An Adaptive Randomized Platform Trial to Investigate the Efficacy of Novel Agents for Treatment of SARS-CoV-2 Infection Among High-Risk Outpatient Adults.

Authors
Category Primary study
Registry of TrialsPan African Clinical Trials Registry
Year 2020
INTERVENTION: Ascorbic acid Lopinavir ritonavir CONDITION: ; COVID‐19 COVID‐19 PRIMARY OUTCOME: 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 OUTCOME: Hospitalisation Serious adverse events (including death, hospitalization) and adverse events resulting in treatment discontinuation 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 f
Epistemonikos ID: 085fd07cf1817e534ac148c52d86ab6aa03764ef
First added on: Aug 22, 2020