Table 1 Efficacy endpoints

Time to clinical improvement measured as an improvement for ≥ two categories on a 7-point ordinal scale in an up to 28 days time-frame

Time to clinical improvement measured as improvement for ≥ two categories on a 7-point ordinal WHO scale (Time frame: up to 28 days):

1. Not hospitalized, no limitations on activities;

2. Not hospitalized, limitation on activities;

3. Hospitalized, not requiring supplemental oxygen;

4. Hospitalized, requiring supplemental oxygen;

5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;

6. Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO);

7. Death.

Secondary

 Duration of fever

Axillary temperature had returned to 37.2ºC or lower and was maintained at 37.2ºC or lower for at least 3 days.

 Time to discharge or to a NEWS < 3 (whichever occurred first)

Only for all the patients whose NEWS scores were ≥ 3 points (at any time of the study) was defined as the duration until the patient was discharged or his/her total NEWS scores were maintained for 24 h under 3 points.

 Time until weaning from oxygen therapy

Time until the patients who had a punctuation above 3 on the WHO ordinal scale of the clinical status, reached the category: “3. Hospitalized but not requiring supplemental oxygen” or lower and maintained it for 24 h.

 Time until weaning from mechanical ventilation was defined as the

Time until the patients who had a punctuation of 6 on the WHO ordinal scale of the clinical status, reached the category: “5. Hospitalized, on non-invasive ventilation or high flow oxygen devices” or lower and maintain it for 24 h.

 The time to hospital discharge

Time until the day of hospital discharge.

Exploratory

 Time to negative SARS-CoV-2 PCR Test

Days up to negative SARS-CoV-2 PCR Test.

 Time to positive SARS-COV-2 antibody IgG test

Days up to positive SARS-COV-2 antibody IgG test.