Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male and Non-pregnant Female 2 Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen 3 Either asymptomatic or have only mild symptoms ((cough and/or fever and/or sore throat and/or other upper respiratory symptoms) at the time of study inclusion 4 Oxygen saturation of >94% while breathing ambient air, if this is measured 5 Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. 6 Patients with high blood sugar or glycosylated haemoglobin, of any degree 7 Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate levels
Exclusion criteria
Exclusion criteria: 1 Have pneumonia confirmed by chest imaging, OR 2 Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air 3 Have any Grade 2 or worse laboratory abnormality, including haematological, renal, liver, electrolyes.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1 All-cause mortality at 28 days after randomization 2 Overall Survival times in days 3 The proportion of patients with virological positivity 4 The proportion of patients with clinical improvement at day 14Timepoint: Day 28 Day 28 Day 10 Day 14 | — |
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients who suffer clinical deterioration OR viral persistence at Day 10 from the date of randomization (excluding the date of randomization) Clinical deterioration will be defined as defined as a 2-point or greater deterioration on a 7-point ordinal scale in every patient measured on each day, until Day 10 from the date of randomization.Timepoint: Day 10 | — |
Countries
India
Contacts
Public ContactVikram Gota
Advanced Centre for Treatment, Research and Education in Cancer , Tata Memorial Centre
Outcome results
None listed