Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: BRII-196 and BRII-198: 1000 mg Intravenous Infusion single dose only
Treatment Duration is SINGLE DOSE ONLY
Intervention2: VIR-7831: 500 mg Intravenous Infusion single dose only
Treat
Sponsors
National Institute of Allergy and Infectious Diseases NIAID National Institutes of Health NIH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age more than or equal to 18 years 2. Informed consent by the patient or the patientâ??s legally-authorized representative (LAR) 3. SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests will be maintained.)
Exclusion criteria
Exclusion criteria: 1. Prior receipt of Any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19 or SARS-CoV-2 nMAb at any time prior to hospitalization; 2. Not willing to abstain from participation in other COVID-19 treatment trials until after Day 5 (with the approval of study leadership, enrollment before or on Day 5 is permitted for trials comparing different approaches for implementing SOC interventions 3. In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments; 4. Expected inability to participate in study procedures; 5. Women of child-bearing potential who are not already pregnant at study entry and who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with men or practice appropriate contraception through 18 months of the study. 6. Men who are unwilling to acknowledge the strong advice to abstain from sexual intercourse with women of child-bearing potential or to use barrier contraception through 18 months of the study. Prior to the initial futility assessment for an investigational agent, the following two additional exclusions (7 and 8) which define disease severity stratum 2 apply: 7. Presence at enrollment of any of the following: a. stroke b. meningitis c. encephalitis d. myelitis e. myocardial infarction f. myocarditis g. pericarditis h. symptomatic CHF (NYHA class III-IV) i. arterial or deep venous thrombosis or pulmonary embolism 8. Current requirement for any of the following: a. invasive mechanical ventilation b. ECMO c. mechanical circulatory support d. vasopressor therapy e. commencement of renal replacement therapy at this admission (i.e. not patients on chronic renal replacement therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Is time from randomization to sustained recovery, defined as being discharged from the index hospitalization, followed by being alive and home for 14 consecutive days prior to Day 90.Timepoint: Day 0,1,2,3,4,5,6,7,14,28, 42,60,75 and 90. Month 6,12 and 18 | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to death will be compared between the investigational agent versus control groupTimepoint: Day 0,1,2,3,4,5,6,7,14,28, 42,60,75 and 90. Month 6,12 and 18 | — |
Countries
Argentina, Australia, Brazil, Chile, Denmark, France, Georgia, Germany, Greece, India, Israel, Japan, Mexico, Nigeria, Peru, Poland, Portugal, Singapore, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States of America
Contacts
Public ContactDrNKumarasamy
VHS-Infectious Diseases Medical Centre
Outcome results
None listed