COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN13857593

Dr Giorgio Reine

giorgio.reiner@apr.ch

2021-05-12

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Current inclusion criteria as of 29/07/2021: 1. Patient informed consent form (ICF) signed 2. Aged =18 and =64 years at the time of the signature of ICF 3. Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact 4. Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version as of 27/05/2020). In the study will be enrolled COVID-19 patient with RT-PCR Ct value =30 for =2 genes out of 4, at the first swab. The enrollment of COVID-19 vaccinated patients will be allowed if they will present a “clinical vaccination failure”, defined according to the indications reported in the “Global Manual on Surveillance of AE Following Immunization” (WHO guidelines) 5. Onset of symptoms from not more than 2/3 days Previous inclusion criteria: 1. Patient informed consent form (ICF) signed 2. Aged =18 and <64 years at the time of the signature of ICF 3. Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact 4. Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version as of 27/05/2020). In the study will be enrolled COVID-19 patient with RT-PCR Ct value <30 for =2 genes out of 4, at the first swab. 5. Onset of symptoms from not more than 2/3 days

Current exclusion criteria as of 29/07/2021: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 7. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 8. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 9. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 10. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 11. Prior hospitalization for COVID-19 12. Positive pregnancy test or breastfeeding woman 13. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 14. History of severe drug and/or food allergies and/or known allergies to the trial product or its components 15. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient Previous exclusion criteria: 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases) 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values 3. Immune system illnesses 4. Known drug and/or alcohol abuse 5. Individuals who are cognitively impaired and/or who are unable to give informed consent 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine) 7. Vaccination with COVID-19 vaccine 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV) 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity 12. Prior hospitalization for COVID-19 13. Positive pregnancy test or breastfeeding woman 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient 15. History of severe dr

3

Applied Pharma Research (Switzerland)

18

64

Italy

Mild disease at enrollment

1: Mild disease at enrollment

57

1. Viral load in COVID-19 patients measured using quantitative swab test with RT-PCR at baseline; 1; 2; 3; 4; 5; 6; 10; and 21 days (three swabs daily on day 1 and 2; and one swab daily on other days)

Not reported

[{"arm_notes": "3 times/day for 5 days", "treatment_id": 1185, "treatment_name": "Sentinox", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "5 times/day for 5 days", "treatment_id": 1185, "treatment_name": "Sentinox", "treatment_type": "Medical device", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]