Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 3: B338- Other specified viral diseases Health Condition 4: J168- Pneumonia due to other specified infectious organisms
Conditions
Interventions
None listed
Sponsors
nil
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age =18 years at time of signing Informed Consent Form 2. Laboratory (RT-PCR) confirmed COVID-19. 3. Lung involvement confirmed with chest imaging 4. Hospitalized with a SaO2/SPO2=94% on room air or Pa02/Fi02 ratio 5. =12 days since illness onset 6. Have given consent to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Severe liver disease (e.g. Child Pugh score = C, AST >5 times upper limit) 2. Pregnant or breastfeeding, or positive pregnancy test in a pre dose examination 3. Patients with known severe renal impairment (estimated glomerular filtration rate =30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis 4. Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] Defined as the time (in days) from starting of study treatment (Remdesivir) along with the standard of care until a decline of two categories on a Six category ordinal scale of clinical status (1 ? discharged; 6 ? death) or live discharge from hospital. Timepoint: 1.Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] Defined as the time (in days) from starting of study treatment (Remdesivir) along with the standard of care until a decline of two categories on a Six category ordinal scale of clinical status (1 ? discharged; 6 ? death) or live discharge from hospital. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Clinical status, assessed (days 7, 14, 21, and 28). 2. Time to hospital discharge or NEWS2 (National Early Warning Score 2) of = 2 maintained for 24 hours. 3. All cause mortality Duration (days) of mechanical ventilation Duration (days) of supplemental oxygenation Length of hospital stay (days) 4. Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens 5. Frequency of serious adverse drug events [ All Time Frame: up to 28 days ] Timepoint: up to 28 days from starting study drugs. | — |
Countries
India
Contacts
Public ContactANJAN CHATTOPADHYAY
Medical College Hospital Kolkata
Outcome results
None listed