COVID-19
Conditions
Interventions
Ascorbic acid
Sponsors
Cytel Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Participants are eligible to be included in the study only if all of the following criteria apply: High-risk cohort: 1. Men or women 18-80 years, inclusive, at the time of signing the informed consent 2. Willing and able to provide informed consent 3. Laboratory confirmed SARS-CoV-2 infection, with test results within past 72 hours 4. At increased risk of developing severe COVID-19 disease (at least one of the following) • Age =60 • Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease (COPD), pulmonary hypertension, emphysema, or tuberculosis on treatment • Diabetes mellitus (type 1 or type 2), requiring oral medication or insulin for treatment • Hypertension, requiring at least 1 antihypertensive oral medication for treatment • Coronary artery disease with history of graft or stent • Cardiac failure, Class 2 or greater using New York Heart Association functional class • History of organ or stem cell transplant • Immunocompromised status due to disease (e.g., those living with human immunodeficiency virus, confirmed malignancy) • Immunocompromised status due to medication (e.g., persons taking 20 mg or more of prednisone equivalents a day, anti-inflammatory monoclonal antibody therapies, or cancer therapies) • Body mass index = 30 kg/m2
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: 1. Known hypersensitivity to any of the study drugs 2. Currently hospitalized 3. Signs of respiratory distress prior to randomization, including respiratory rate >24 per minute and/or SpO2 470 ms in males, and > 480 ms in females if indicated by the safety profile of the investigational product 9. Potentially clinically significant pharmacokinetic and pharmacodynamic drug interactions as determined by the study clinical pharmacologist* 10. Currently participating in a clinical trial currently or within 30 days of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LRTI, defined by SpO2<93% or decline from baseline of 6% in 2 measurements at least 2 hours apart. ;Time to clearance of nasal SARS-CoV-2, defined as 1 negative swab. | — |
Secondary
| Measure | Time frame |
|---|---|
| Serious adverse events (including death, hospitalization) and adverse events resulting in treatment discontinuation ;Hospitalisation | — |
Countries
South Africa
Contacts
Public ContactCaroldine Neal
Study Coordinator
Outcome results
None listed