Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Resveratrol-Copper tablets: Patients will receive Resveratrol-Copper tablets. Each tablet contains 5.6 mg of Resveratrol and 560 ng of Copper. Route - per oral.
Frequency - 1 tablet 4 t
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and non-pregnant female patients 2 Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen 3 Pneumonia confirmed by chest imaging 4 Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air 5 Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) abnormalities in any of these parameters. 6 Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible 7 Arterial blood gas, if done, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels
Exclusion criteria
Exclusion criteria: Asymptomatic or only mildly symptomatic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time to clinical improvement, defined as a 2-point improvement on a 7-point ordinal scale will be the primary endpoint.Timepoint: Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 All-cause mortality at 28 days after randomization (28-day mortality) in the 3 arms. 2 Overall Survival times in days (with any-cause death constituting an event) 3 The proportion of patients with virological positivity, (estimated by an approved PCR test in throat and/or nasal swab specimen) at 10 days after randomization. 4 The proportion of patients with clinical improvement at day 14 after randomization.Timepoint: Day 28 Day 28 Day 10 Day 14 | — |
Countries
India
Contacts
Public ContactVikram Gota
ACTREC,
Outcome results
None listed