Created at Source Raw Value Validated value
June 4, 2022, 2 p.m. usa

Feb. 17, 2022, 5 p.m. usa

known hypersensitivity or intolerance to interferon (ifn) or novaferon or any excipient(s) of novaferon, including pre-existing allergy or hypersensitivity to ampicillin. currently undergoing invasive mechanical ventilation (including venous ecmo). inability to use a nebulizer with a mouthpiece. alt/ast > 5 times the upper limit of normal (uln) or a history of decompensated cirrhosis. stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr < 30 ml/min/ 1.73m2). in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. possibility of the patient being discharged from hospital within 24 hours. concurrent participation in other anti-covid-19 therapeutic or interventional trials. patients may, at the discretion of the investigator, concurrently participate in other non-interventional covid-19 studies. prior or concurrent use of experimental antiviral therapy for covid-19 that includes lopinavir/ritonavir, convalescent plasma, ivermectin, neutralization antibodies or chloroquine/hydroxychloroquine (remdesivir allowed) (see section 9.4.1). prior or concurrent use of jak inhibitors for the treatment of covid-19 (anti-il-6 agents allowed) (see section 9.4.1). prior or concurrent use of any interferons other than the investigational product (see section 9.4.1) other known active infections or other clinical conditions (e.g., severe chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation. patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, and patients with prior transplants. females who are breast-feeding, lactating, pregnant or intending to become pregnant. the subject has any medical condition that in the opinion of the investigator would compromise subject's safety or compliance with study procedures.

known hypersensitivity or intolerance to interferon (ifn) or novaferon or any excipient(s) of novaferon, including pre-existing allergy or hypersensitivity to ampicillin. currently undergoing invasive mechanical ventilation (including venous ecmo). inability to use a nebulizer with a mouthpiece. alt/ast > 5 times the upper limit of normal (uln) or a history of decompensated cirrhosis. stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr < 30 ml/min/ 1.73m2). in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. possibility of the patient being discharged from hospital within 24 hours. concurrent participation in other anti-covid-19 therapeutic or interventional trials. patients may, at the discretion of the investigator, concurrently participate in other non-interventional covid-19 studies. prior or concurrent use of experimental antiviral therapy for covid-19 that includes lopinavir/ritonavir, convalescent plasma, ivermectin, neutralization antibodies or chloroquine/hydroxychloroquine (remdesivir allowed) (see section 9.4.1). prior or concurrent use of jak inhibitors for the treatment of covid-19 (anti-il-6 agents allowed) (see section 9.4.1). prior or concurrent use of any interferons other than the investigational product (see section 9.4.1) other known active infections or other clinical conditions (e.g., severe chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation. patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease, and patients with prior transplants. females who are breast-feeding, lactating, pregnant or intending to become pregnant. the subject has any medical condition that in the opinion of the investigator would compromise subject's safety or compliance with study procedures.

Dec. 18, 2020, 12:31 a.m. usa

- 1. known hypersensitivity or intolerance to interferon (ifn) or novaferon or any excipient(s) of novaferon, including pre-existing allergy or hypersensitivity to ampicillin. - currently undergoing invasive mechanical ventilation (including venous ecmo). - inability to use a nebulizer with a mouthpiece. - alt/ast > 5 times the upper limit of normal or a history of decompensated cirrhosis. - stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr < 30 ml/min/ 1.73m2). - in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. - in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. - possibility of the patient being discharged from hospital within 24 hours. - participation in other anti-covid-19 therapeutic or interventional trials. patients may, at the discretion of the investigator, participate in other non-interventional covid-19 studies. - current use of other antiviral therapy (e.g. remdesivir, etc.) or other experimental therapy, including anti-inflammatory agents, convalescent plasma, or hydroxychloroquine - has received, or has a plan to receive within the 28 day treatment period, a sars-cov-2 vaccine. - use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of chronic oral corticosteroids for a non-covid-19-related condition at a dose higher than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks. - other known active infections or other clinical conditions (e.g. chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed. - patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. - females who are breast-feeding, lactating, pregnant or intending to become pregnant. - positive for hepatitis b, hepatitis c or uncontrolled hiv

- 1. known hypersensitivity or intolerance to interferon (ifn) or novaferon or any excipient(s) of novaferon, including pre-existing allergy or hypersensitivity to ampicillin. - currently undergoing invasive mechanical ventilation (including venous ecmo). - inability to use a nebulizer with a mouthpiece. - alt/ast > 5 times the upper limit of normal or a history of decompensated cirrhosis. - stage 4 severe chronic kidney disease or requiring dialysis (i.e. egfr < 30 ml/min/ 1.73m2). - in the opinion of the investigator, progression to death is imminent and inevitable within the next 48 - 72 hours, irrespective of the provision of treatment. - in the opinion of the investigator, progression to mechanical ventilation is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment. - possibility of the patient being discharged from hospital within 24 hours. - participation in other anti-covid-19 therapeutic or interventional trials. patients may, at the discretion of the investigator, participate in other non-interventional covid-19 studies. - current use of other antiviral therapy (e.g. remdesivir, etc.) or other experimental therapy, including anti-inflammatory agents, convalescent plasma, or hydroxychloroquine - has received, or has a plan to receive within the 28 day treatment period, a sars-cov-2 vaccine. - use of immunomodulatory drugs at, or within 3 months prior to, enrollment; use of chronic oral corticosteroids for a non-covid-19-related condition at a dose higher than prednisone 20 mg (or equivalent) per day for the preceding 4 weeks. - other known active infections or other clinical conditions (e.g. chronic obstructive pulmonary disease) that contraindicate aerosolized inhalation; coexisting pneumonia is allowed. - patients with current or prior psychiatric illness, seizure disorders, retinal autoimmune disorders, pre-existing severe cardiovascular disease and patients with prior transplants. - females who are breast-feeding, lactating, pregnant or intending to become pregnant. - positive for hepatitis b, hepatitis c or uncontrolled hiv