Created at Source Raw Value Validated value
April 22, 2022, 4:30 a.m. eu

1. The patient, in the opinion of the investigator, is not likely to survive for ≥48 hours beyond Day 1. 2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1. a) Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms. b) Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness but no clinical signs indicative of moderate, severe, or critical COVID-19. c) Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least 1 of the following: shock defined by systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg, or requiring vasopressors, respiratory failure requiring endotracheal intubation and invasive mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5), non-invasive 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), and/or multi-organ dysfunction/failure. 3. The patient has a Child Pugh score ≥ C. 4. The patient has a documented medical history of infection with hepatitis A, B, or C at screening or Day 1. 5. The patient has a documented medical history of infection with human immunodeficiency virus and has a detectable viral load and CD4 count <500 cells/μL. 6. The patient has a documented active infection with tuberculosis at screening or Day 1. 7. The patient has clinically significant electrocardiogram abnormalities at screening. 8. A female patient who is pregnant, planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) and before dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests. 9. The patient is planning to donate or bank ova or sperm from Day 1 until 30 days after the last dose of study drug. 10. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study. 11. The patient has a history of sensitivity to any of the study medications, components thereof (eg, mannitol or gelatin), or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation. 12. The patient has participated in and/or plans to participate in another clinical study using an investigational product within the following period before the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). 13. The patient will be transferred to another hospital that is not a study site within 72 hours. Please note: If the investigator has admitting privileges to the transfer hospital, the patient may be considered for randomization. 14. The patient is employed by MetrioPharm, the contract research organization or clinical site involved in the clinical study. 15. The investigator makes a decision that study involvement is not in patient’s best interest, or the patient has any condition, in the opinion of the investigator, that will not allow the protocol to be followed safely.

1. The patient, in the opinion of the investigator, is not likely to survive for ≥48 hours beyond Day 1. 2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1. a) Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms. b) Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness but no clinical signs indicative of moderate, severe, or critical COVID-19. c) Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least 1 of the following: shock defined by systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg, or requiring vasopressors, respiratory failure requiring endotracheal intubation and invasive mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen ≥0.5), non-invasive 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), and/or multi-organ dysfunction/failure. 3. The patient has a Child Pugh score ≥ C. 4. The patient has a documented medical history of infection with hepatitis A, B, or C at screening or Day 1. 5. The patient has a documented medical history of infection with human immunodeficiency virus and has a detectable viral load and CD4 count <500 cells/μL. 6. The patient has a documented active infection with tuberculosis at screening or Day 1. 7. The patient has clinically significant electrocardiogram abnormalities at screening. 8. A female patient who is pregnant, planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) and before dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests. 9. The patient is planning to donate or bank ova or sperm from Day 1 until 30 days after the last dose of study drug. 10. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study. 11. The patient has a history of sensitivity to any of the study medications, components thereof (eg, mannitol or gelatin), or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation. 12. The patient has participated in and/or plans to participate in another clinical study using an investigational product within the following period before the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer). 13. The patient will be transferred to another hospital that is not a study site within 72 hours. Please note: If the investigator has admitting privileges to the transfer hospital, the patient may be considered for randomization. 14. The patient is employed by MetrioPharm, the contract research organization or clinical site involved in the clinical study. 15. The investigator makes a decision that study involvement is not in patient’s best interest, or the patient has any condition, in the opinion of the investigator, that will not allow the protocol to be followed safely.