Outcome measures
illness, throat, cough, breathlessness, C axillae
SECONDARY
The primary efficacy measure was (i) the mean duration (days) from baseline randomization to day one of clinical recovery (CR) and (ii) the proportion of patients showing clinical recovery, within a time framework of 28 days. Clinical recovery was accepted when all of the following criteria were met for at least 48 hours under the observation of the hospital COVID-19 physician (a) normal body temperature (≤36.6°C axillae or ≤37.2°C oral) (b) absence of cough requiring regular medication (c)absence of breathlessness on routine daily self-care activities and respiratory rate less than 30 breaths per minute without supplemental oxygen (d) absence of any other symptom/sign attributed to COVID-19 illness and requiring continuous treatment (e) normal SpO2 by standard peripheral oximetry device (above 95 percent)(f) negative RT-PCR assay for SARS-CoV-2 from nasal and throat swab. The checklist of symptoms that were monitored daily for recovery was also guided by the WHO guideline [There were several secondary efficacy measures pertaining to (i) timelines such as the mean duration from onset of symptoms to CR, mean duration from hospitalization to CR (ii) COVID-19-related blood assay biomarkers such as C-reactive protein (CRP), D-Dimer, Ferritin, interleukin-6. They are described in the enclosed protocol (