1. subjects with a pre-baseline (i.e., in the month preceding the current covid-19 infection) impairment in general health condition for whatever reason except covid-19, with a severe dependency for daily living activities (barthel index ≤ 60/100) or chronic oxygen therapy. 2. having received treatment for covid-19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, non-invasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the aforementioned therapies, which could not be administered in a resource-limited setting). 4. patients with severe covid-19, meeting score \>5 on the 11-point who clinical progression scale or presenting, after an initial stabilisation prior to randomisation, any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 \<300. in case a direct measure of pao2 has not been obtained, it should be imputed according to a referenced formula. for sites located over 1000 m above sea level, pao2/fio2 ratio will be adjusted. 5. patients receiving, at randomisation, treatment with antiviral therapy against sars-cov-2 or requiring anti-inflammatory/immunomodulating drugs beyond glucocorticoids with the exceptions listed below: * prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: 1. the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. 2. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. * prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: 1. the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. 2. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. * prior administration of an antiviral might be acceptable in the following circumstances: 1. for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir/ritonavir), they must have been given for an earlier stage of the disease, outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of previous antiviral drugs should have been administered at least 24 h before randomisation. 2. for antiviral monoclonal antibodies, they must have been given for an earlier stage of the disease (including pre-exposure prophylaxis), outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of antiviral monoclonal antibodies should have been administered at least 1 week before randomisation. 6. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study. 7. patients receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers. 8. viral illness (other than covid-19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection. 9. patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (i.e., prednisone at a daily dose of \>10 mg for \>1 month, or another glucocorticoid at equipotent dose). 10. any of the following cardiac conditions or risk factors: * sinus bradycardia (\<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr \>200 msec), or any other bradyarrhythmia (\<50 beats/min), except for patients with permanent pacemakers; * cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; * known abnormal value of left ventricular ejection fraction (lvef \<low limit of normal (lln)), unless documented confirmation of recovery (lvef \>lln) in the previous month; * qt interval corrected using fridericia's formula (qtcf) \>450 msec for males or \>470 msec for females; * history of known congenital or acquired qt prolongation; * uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at screening; * troponin test performed at local laboratory \>1.5 x uln; or * need for an unreplaceable drug that prolongs qt and it is clearly associated with a known risk for torsades de pointes (tdp); in case of being already on treatment with these aforementioned drugs, a minimum of 4 half-lives of the drug is required before replacement (if feasible). 11. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or patients for whom dexamethasone, antihistamine h1/h2 or antiserotoninergic agents are contraindicated. 12. females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding. 13. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least 1 protocol specified method of contraception. 14. any other clinically significant medical condition (including major surgery within the last 3 weeks before screening) or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact on patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (i.e., in the month preceding the current covid-19 infection) impairment in general health condition for whatever reason except covid-19, with a severe dependency for daily living activities (barthel index ≤ 60/100) or chronic oxygen therapy. 2. having received treatment for covid-19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, non-invasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the aforementioned therapies, which could not be administered in a resource-limited setting). 4. patients with severe covid-19, meeting score \>5 on the 11-point who clinical progression scale or presenting, after an initial stabilisation prior to randomisation, any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 \<300. in case a direct measure of pao2 has not been obtained, it should be imputed according to a referenced formula. for sites located over 1000 m above sea level, pao2/fio2 ratio will be adjusted. 5. patients receiving, at randomisation, treatment with antiviral therapy against sars-cov-2 or requiring anti-inflammatory/immunomodulating drugs beyond glucocorticoids with the exceptions listed below: * prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: 1. the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. 2. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. * prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: 1. the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. 2. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. * prior administration of an antiviral might be acceptable in the following circumstances: 1. for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir/ritonavir), they must have been given for an earlier stage of the disease, outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of previous antiviral drugs should have been administered at least 24 h before randomisation. 2. for antiviral monoclonal antibodies, they must have been given for an earlier stage of the disease (including pre-exposure prophylaxis), outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of antiviral monoclonal antibodies should have been administered at least 1 week before randomisation. 6. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study. 7. patients receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers. 8. viral illness (other than covid-19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection. 9. patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (i.e., prednisone at a daily dose of \>10 mg for \>1 month, or another glucocorticoid at equipotent dose). 10. any of the following cardiac conditions or risk factors: * sinus bradycardia (\<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr \>200 msec), or any other bradyarrhythmia (\<50 beats/min), except for patients with permanent pacemakers; * cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; * known abnormal value of left ventricular ejection fraction (lvef \<low limit of normal (lln)), unless documented confirmation of recovery (lvef \>lln) in the previous month; * qt interval corrected using fridericia's formula (qtcf) \>450 msec for males or \>470 msec for females; * history of known congenital or acquired qt prolongation; * uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at screening; * troponin test performed at local laboratory \>1.5 x uln; or * need for an unreplaceable drug that prolongs qt and it is clearly associated with a known risk for torsades de pointes (tdp); in case of being already on treatment with these aforementioned drugs, a minimum of 4 half-lives of the drug is required before replacement (if feasible). 11. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or patients for whom dexamethasone, antihistamine h1/h2 or antiserotoninergic agents are contraindicated. 12. females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding. 13. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for \>12 months) who are not using at least 1 protocol specified method of contraception. 14. any other clinically significant medical condition (including major surgery within the last 3 weeks before screening) or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact on patient compliance or the safety/efficacy observations in the study.

subjects with a pre-baseline (i.e., in the month preceding the current covid-19 infection) impairment in general health condition for whatever reason except covid-19, with a severe dependency for daily living activities (barthel index ≤ 60/100) or chronic oxygen therapy. having received treatment for covid-19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, non-invasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the aforementioned therapies, which could not be administered in a resource-limited setting). patients with severe covid-19, meeting score >5 on the 11-point who clinical progression scale or presenting, after an initial stabilisation prior to randomisation, any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 <300. in case a direct measure of pao2 has not been obtained, it should be imputed according to a referenced formula. for sites located over 1000 m above sea level, pao2/fio2 ratio will be adjusted. patients receiving, at randomisation, treatment with antiviral therapy against sars-cov-2 or requiring anti-inflammatory/immunomodulating drugs beyond glucocorticoids with the exceptions listed below: prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. prior administration of an antiviral might be acceptable in the following circumstances: for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir/ritonavir), they must have been given for an earlier stage of the disease, outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of previous antiviral drugs should have been administered at least 24 h before randomisation. for antiviral monoclonal antibodies, they must have been given for an earlier stage of the disease (including pre-exposure prophylaxis), outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of antiviral monoclonal antibodies should have been administered at least 1 week before randomisation. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study. patients receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers. viral illness (other than covid-19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection. patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (i.e., prednisone at a daily dose of >10 mg for >1 month, or another glucocorticoid at equipotent dose). any of the following cardiac conditions or risk factors: sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; known abnormal value of left ventricular ejection fraction (lvef <low limit of normal (lln)), unless documented confirmation of recovery (lvef >lln) in the previous month; qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females; history of known congenital or acquired qt prolongation; uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at screening; troponin test performed at local laboratory >1.5 x uln; or need for an unreplaceable drug that prolongs qt and it is clearly associated with a known risk for torsades de pointes (tdp); in case of being already on treatment with these aforementioned drugs, a minimum of 4 half-lives of the drug is required before replacement (if feasible). hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or patients for whom dexamethasone, antihistamine h1/h2 or antiserotoninergic agents are contraindicated. females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least 1 protocol specified method of contraception. any other clinically significant medical condition (including major surgery within the last 3 weeks before screening) or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact on patient compliance or the safety/efficacy observations in the study.

subjects with a pre-baseline (i.e., in the month preceding the current covid-19 infection) impairment in general health condition for whatever reason except covid-19, with a severe dependency for daily living activities (barthel index ≤ 60/100) or chronic oxygen therapy. having received treatment for covid-19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, non-invasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the aforementioned therapies, which could not be administered in a resource-limited setting). patients with severe covid-19, meeting score >5 on the 11-point who clinical progression scale or presenting, after an initial stabilisation prior to randomisation, any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 <300. in case a direct measure of pao2 has not been obtained, it should be imputed according to a referenced formula. for sites located over 1000 m above sea level, pao2/fio2 ratio will be adjusted. patients receiving, at randomisation, treatment with antiviral therapy against sars-cov-2 or requiring anti-inflammatory/immunomodulating drugs beyond glucocorticoids with the exceptions listed below: prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: the total daily dose is not higher than 10 mg of dexamethasone phosphate (equivalent to dexamethasone base 8.25 mg/day) or equivalent glucocorticoids. the duration of the treatment does not exceed 72 hours prior to study treatment day 1. prior administration of an antiviral might be acceptable in the following circumstances: for small molecules (e.g., remdesivir, molnupiravir, nirmaltrevir/ritonavir), they must have been given for an earlier stage of the disease, outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of previous antiviral drugs should have been administered at least 24 h before randomisation. for antiviral monoclonal antibodies, they must have been given for an earlier stage of the disease (including pre-exposure prophylaxis), outside a clinical trial, and there should be a documentation of objective clinical deterioration plus evidence of persisting positivity for sars-cov-2 in appropriate biological samples. last dose of antiviral monoclonal antibodies should have been administered at least 1 week before randomisation. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study. patients receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers. viral illness (other than covid-19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection. patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (i.e., prednisone at a daily dose of >10 mg for >1 month, or another glucocorticoid at equipotent dose). any of the following cardiac conditions or risk factors: sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; known abnormal value of left ventricular ejection fraction (lvef <low limit of normal (lln)), unless documented confirmation of recovery (lvef >lln) in the previous month; qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females; history of known congenital or acquired qt prolongation; uncorrected hypokalaemia, hypocalcaemia (adjusted) and/or hypomagnesemia at screening; troponin test performed at local laboratory >1.5 x uln; or need for an unreplaceable drug that prolongs qt and it is clearly associated with a known risk for torsades de pointes (tdp); in case of being already on treatment with these aforementioned drugs, a minimum of 4 half-lives of the drug is required before replacement (if feasible). hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) or patients for whom dexamethasone, antihistamine h1/h2 or antiserotoninergic agents are contraindicated. females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least 1 protocol specified method of contraception. any other clinically significant medical condition (including major surgery within the last 3 weeks before screening) or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact on patient compliance or the safety/efficacy observations in the study.

subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities (barthel index <90/100) or chronic oxygen therapy having received treatment for covid 19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) patients with severe covid 19, meeting score >5 on the 11 point who clinical progression scale or presenting during the screening any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 <300 patients receiving treatment with antiviral therapy against sars-cov-2 (either small molecules or antibodies, convalescent plasma, monoclonal antibodies, il 6 receptor inhibitor, or immunomodulatory drugs) within 2 weeks before enrolment. prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: the total daily dose is not higher than 6 mg of dexamethasone base (equivalent to dexamethasone phosphate 7.2 mg/day) or equivalent glucocorticoid the duration of the treatment does not exceed 72 hours prior to study treatment day 1 history of live vaccination within the last 4 weeks prior to study enrolment. regulatory approved, nonreplicative viral vector based vaccines are allowed if given not earlier than 1 week previous to day 1. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study patients receiving treatment with strong cytochrome p450 3a4 ( cyp3a4) inhibitors or inducers viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for >1 month, or other glucocorticoid at equipotent dose) any of the following cardiac conditions or risk factors: sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; known abnormal value of left ventricular ejection fraction (lvef < lln), unless documented confirmation of recovery (lvef > lln) in the previous month; qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate 12-lead ecg at screening history of known congenital or acquired qt prolongation uncorrected hypokalaemia, hypocalcaemia (adjusted), and/or hypomagnesemia at screening concomitant treatments with drugs known to be associated with a risk of qt prolongation or cardiac arrhythmia troponin test performed at local laboratory > 1.5 x uln pre-existing neuropathies of any type grade ≥2 according to national cancer institute common terminology criteria for adverse events (nci ctcae) version 5.0 hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities (barthel index <90/100) or chronic oxygen therapy having received treatment for covid 19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) patients with severe covid 19, meeting score >5 on the 11 point who clinical progression scale or presenting during the screening any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 <300 patients receiving treatment with antiviral therapy against sars-cov-2 (either small molecules or antibodies, convalescent plasma, monoclonal antibodies, il 6 receptor inhibitor, or immunomodulatory drugs) within 2 weeks before enrolment. prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: the total daily dose is not higher than 6 mg of dexamethasone base (equivalent to dexamethasone phosphate 7.2 mg/day) or equivalent glucocorticoid the duration of the treatment does not exceed 72 hours prior to study treatment day 1 history of live vaccination within the last 4 weeks prior to study enrolment. regulatory approved, nonreplicative viral vector based vaccines are allowed if given not earlier than 1 week previous to day 1. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study patients receiving treatment with strong cytochrome p450 3a4 ( cyp3a4) inhibitors or inducers viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for >1 month, or other glucocorticoid at equipotent dose) any of the following cardiac conditions or risk factors: sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; known abnormal value of left ventricular ejection fraction (lvef < lln), unless documented confirmation of recovery (lvef > lln) in the previous month; qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate 12-lead ecg at screening history of known congenital or acquired qt prolongation uncorrected hypokalaemia, hypocalcaemia (adjusted), and/or hypomagnesemia at screening concomitant treatments with drugs known to be associated with a risk of qt prolongation or cardiac arrhythmia troponin test performed at local laboratory > 1.5 x uln pre-existing neuropathies of any type grade ≥2 according to national cancer institute common terminology criteria for adverse events (nci ctcae) version 5.0 hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities (barthel index <90/100) or chronic oxygen therapy 2. having received treatment for covid 19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) 4. patients with severe covid 19, meeting score >5 on the 11 point who clinical progression scale or presenting during the screening any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 <300 5. patients receiving treatment with antiviral therapy against sars-cov-2 (either small molecules or antibodies, convalescent plasma, monoclonal antibodies, il 6 receptor inhibitor, or immunomodulatory drugs) within 2 weeks before enrolment. prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: 1. the total daily dose is not higher than 6 mg of dexamethasone base (equivalent to dexamethasone phosphate 7.2 mg/day) or equivalent glucocorticoid 2. the duration of the treatment does not exceed 72 hours prior to study treatment day 1 6. history of live vaccination within the last 4 weeks prior to study enrolment. regulatory approved, nonreplicative viral vector based vaccines are allowed if given not earlier than 1 week previous to day 1. 7. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study 8. patients receiving treatment with strong cytochrome p450 3a4 ( cyp3a4) inhibitors or inducers 9. viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection 10. patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for >1 month, or other glucocorticoid at equipotent dose) 11. any of the following cardiac conditions or risk factors: - sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; - cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; - known abnormal value of left ventricular ejection fraction (lvef < lln), unless documented confirmation of recovery (lvef > lln) in the previous month; - qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate 12-lead ecg at screening - history of known congenital or acquired qt prolongation - uncorrected hypokalaemia, hypocalcaemia (adjusted), and/or hypomagnesemia at screening - concomitant treatments with drugs known to be associated with a risk of qt prolongation or cardiac arrhythmia - troponin test performed at local laboratory > 1.5 x uln 12. pre-existing neuropathies of any type grade ≥2 according to national cancer institute common terminology criteria for adverse events (nci ctcae) version 5.0 13. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) 14. females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding 15. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception 16. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities (barthel index <90/100) or chronic oxygen therapy 2. having received treatment for covid 19 in another clinical trial in the prior 4 weeks, except documented allocation in a placebo arm. 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least one of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) 4. patients with severe covid 19, meeting score >5 on the 11 point who clinical progression scale or presenting during the screening any of clinical signs indicative of severe systemic illness, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, or pao2/fio2 <300 5. patients receiving treatment with antiviral therapy against sars-cov-2 (either small molecules or antibodies, convalescent plasma, monoclonal antibodies, il 6 receptor inhibitor, or immunomodulatory drugs) within 2 weeks before enrolment. prior administration of dexamethasone or equivalent glucocorticoid might be acceptable if: 1. the total daily dose is not higher than 6 mg of dexamethasone base (equivalent to dexamethasone phosphate 7.2 mg/day) or equivalent glucocorticoid 2. the duration of the treatment does not exceed 72 hours prior to study treatment day 1 6. history of live vaccination within the last 4 weeks prior to study enrolment. regulatory approved, nonreplicative viral vector based vaccines are allowed if given not earlier than 1 week previous to day 1. 7. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study 8. patients receiving treatment with strong cytochrome p450 3a4 ( cyp3a4) inhibitors or inducers 9. viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection 10. patients with uncontrolled known primary or secondary immunodeficiency, including chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for >1 month, or other glucocorticoid at equipotent dose) 11. any of the following cardiac conditions or risk factors: - sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; - cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; - known abnormal value of left ventricular ejection fraction (lvef < lln), unless documented confirmation of recovery (lvef > lln) in the previous month; - qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate 12-lead ecg at screening - history of known congenital or acquired qt prolongation - uncorrected hypokalaemia, hypocalcaemia (adjusted), and/or hypomagnesemia at screening - concomitant treatments with drugs known to be associated with a risk of qt prolongation or cardiac arrhythmia - troponin test performed at local laboratory > 1.5 x uln 12. pre-existing neuropathies of any type grade ≥2 according to national cancer institute common terminology criteria for adverse events (nci ctcae) version 5.0 13. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) 14. females who are pregnant (negative serum or urine pregnancy test required for all females of child-bearing potential at screening) or breast feeding 15. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception 16. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities or chronic oxygen therapy 2. participating in another clinical trial for treatment of covid 19 infection or patients previously enrolled in clinical trials and currently in follow up, or patients previously vaccinated for covid 19 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) 4. patients clinically indicated for management of sars cov 2 (covid 19), with baseline disease severity rated as severe (if positive testing by standard reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent test, symptoms suggestive of severe illness with covid 19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress, clinical signs indicative of severe systemic illness with covid 19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, spo2 ≤93% on room air at sea level, or pao2/fio2 <300) 5. patients receiving treatment with antivirals, interleukin (il) 6 receptor inhibitor, corticosteroids, or immunomodulatory drugs for covid 19 infection within 4 weeks before enrolment 6. history of live vaccination within the last 4 weeks prior to study enrolment; subjects must not receive live, attenuated influenza vaccine within 4 weeks before enrolment or at any time during the study 7. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study 8. receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers (see appendix 4) 9. viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection are eligible 10. any of the following cardiac conditions or risk factors: - sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; - cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; - known abnormal value of left ventricular ejection fraction (lvef < lln), unless documented confirmation of recovery (lvef > lln) in the previous month; - qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate ecg at screening - history of known congenital or acquired qt prolongation - uncorrected hypokalaemia, hypoglycaemia (adjusted) and/or hypomagnesemia at baseline - concomitant treatments with drugs known to be associated with a risk of qt prolongation or cardiac arrhythmia - troponin test performed at local laboratory > 1.5 x uln 11. pre-existing neuropathies of any type grade ≥2 12. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) 13. females who are pregnant (negative serum pregnancy test required for all females of child-bearing potential at screening) or breast feeding 14. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception 15. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities or chronic oxygen therapy 2. participating in another clinical trial for treatment of covid 19 infection or patients previously enrolled in clinical trials and currently in follow up, or patients previously vaccinated for covid 19 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) 4. patients clinically indicated for management of sars cov 2 (covid 19), with baseline disease severity rated as severe (if positive testing by standard reverse transcription polymerase chain reaction (rt-pcr) assay or equivalent test, symptoms suggestive of severe illness with covid 19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress, clinical signs indicative of severe systemic illness with covid 19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, spo2 ≤93% on room air at sea level, or pao2/fio2 <300) 5. patients receiving treatment with antivirals, interleukin (il) 6 receptor inhibitor, corticosteroids, or immunomodulatory drugs for covid 19 infection within 4 weeks before enrolment 6. history of live vaccination within the last 4 weeks prior to study enrolment; subjects must not receive live, attenuated influenza vaccine within 4 weeks before enrolment or at any time during the study 7. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study 8. receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers (see appendix 4) 9. viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection are eligible 10. any of the following cardiac conditions or risk factors: - sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrioventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (<50 beats/min), except for patients with permanent pacemakers; - cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; - known abnormal value of left ventricular ejection fraction (lvef < lln), unless documented confirmation of recovery (lvef > lln) in the previous month; - qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate ecg at screening - history of known congenital or acquired qt prolongation - uncorrected hypokalaemia, hypoglycaemia (adjusted) and/or hypomagnesemia at baseline - concomitant treatments with drugs known to be associated with a risk of qt prolongation or cardiac arrhythmia - troponin test performed at local laboratory > 1.5 x uln 11. pre-existing neuropathies of any type grade ≥2 12. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol) 13. females who are pregnant (negative serum pregnancy test required for all females of child-bearing potential at screening) or breast feeding 14. females and males with partners of child-bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception 15. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities or chronic oxygen therapy 2. participating in another clinical trial for treatment of covid 19 infection or patients previously enrolled in clinical trials and currently in follow up, or patients previously vaccinated for covid 19 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) 4. patients clinically indicated for management of sars cov 2 (covid 19), with baseline disease severity rated as severe (if positive testing by standard rt pcr assay or equivalent test, symptoms suggestive of severe illness with covid 19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress, clinical signs indicative of severe systemic illness with covid 19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, spo2 ≤93% on room air at sea level, or pao2/fio2 <300) 5. patients receiving treatment with antivirals, il 6 receptor inhibitor, corticosteroids, or immunomodulatory drugs for covid 19 infection within 4 weeks before enrolment 6. history of live vaccination within the last 4 weeks prior to study enrolment; subjects must not receive live, attenuated influenza vaccine within 4 weeks before enrolment or at any time during the study 7. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study 8. receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers (see appendix 4) 9. viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection are eligible 10. any of the following cardiac conditions: *sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrio-ventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (< 50 beats/min), except for patients with permanent pacemarkers; *cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; or *qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate ecg at screening 11. pre-existing neuropathies of any type grade ≥2 12. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol). 13. females who are pregnant (negative serum pregnancy test required for all females of child bearing potential at screening) or breast feeding 14. females and males with partners of child bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception 15. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.

1. subjects with a pre-baseline (ie, in the prior month) impairment in general health condition for whatever reason except covid 19, requiring either assistance for daily living activities or chronic oxygen therapy 2. participating in another clinical trial for treatment of covid 19 infection or patients previously enrolled in clinical trials and currently in follow up, or patients previously vaccinated for covid 19 3. evidence of respiratory failure at the time of randomisation, based on resource utilisation requiring at least 1 of the following: endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive positive pressure ventilation, ecmo, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) 4. patients clinically indicated for management of sars cov 2 (covid 19), with baseline disease severity rated as severe (if positive testing by standard rt pcr assay or equivalent test, symptoms suggestive of severe illness with covid 19, which could include any symptom of moderate illness or shortness of breath at rest, or respiratory distress, clinical signs indicative of severe systemic illness with covid 19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, spo2 ≤93% on room air at sea level, or pao2/fio2 <300) 5. patients receiving treatment with antivirals, il 6 receptor inhibitor, corticosteroids, or immunomodulatory drugs for covid 19 infection within 4 weeks before enrolment 6. history of live vaccination within the last 4 weeks prior to study enrolment; subjects must not receive live, attenuated influenza vaccine within 4 weeks before enrolment or at any time during the study 7. patients receiving treatment with chloroquine or derivatives within 8 weeks before enrolment or during the study 8. receiving treatment with strong cytochrome p450 3a4 (cyp3a4) inhibitors or inducers (see appendix 4) 9. viral illness (other than covid 19) requiring therapy, except for patients with treated and adequately controlled (undetectable) human immunodeficiency virus infection are eligible 10. any of the following cardiac conditions: *sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease), atrio-ventricular block of any degree (pr >200 msec), or any other bradyarrhythmia (< 50 beats/min), except for patients with permanent pacemarkers; *cardiac infarction, cardiac surgery or cardiac insufficiency episode within the last 6 months; or *qt interval corrected using fridericia's formula (qtcf) >450 msec for males or >470 msec for females, based on triplicate ecg at screening 11. pre-existing neuropathies of any type grade ≥2 12. hypersensitivity to the active ingredient or any of the excipients (mannitol, macrogolglycerol hydroxystearate, and ethanol). 13. females who are pregnant (negative serum pregnancy test required for all females of child bearing potential at screening) or breast feeding 14. females and males with partners of child bearing potential (females who are not surgically sterile or postmenopausal defined as amenorrhoea for >12 months) who are not using at least 1 protocol-specified method of contraception 15. any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardise the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.