Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Conditions
Interventions
Intervention1: Remdesivir plus Tocilizumab group: Remdesivir, 200 mg IV on day-1 f/b 100 mg IV on day-2-5. PLUS
Tocilizumab 400 mg slow IV, may be repeated after 12 hours.
Control Intervention1: R
Sponsors
Dr Swati Datta
Dr Asim Kumar Kundu
Eligibility
Inclusion criteria
Inclusion criteria: Patients with moderate to severe COVID-19 disease with following criteria : 1. Age >18 years 2. Laboratory confirmed COVID-19 patients 3. SpO2 94% 4. Patients on different modalities of oxygen therapy 5. Patients with radiologically confirmed pneumonia 6. ARDS / Acute Respiratory Failure Presence of raised inflammatory markers e.g. CRP, ferritin, IL-6
Exclusion criteria
Exclusion criteria: Patients with moderate to severe COVID-19 disease with following criteria : 1. Pregnancy or breast feeding 2. Serum alanine aminotransferase(ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) 3. Known severe renal impairment (eGFR ï?¼30 ml/min/1.73 m2 or on continuous RRT (hemodialysis, peritoneal dialysis) 4. Known severe allergic reactions to tocilizumab or other monoclonal antibodies 5. Known hypersensitivity to remdesivir 6. Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months 7. Absolute neutrophil count (ANC) 8. Clinical evidence of active tuberculosis or blood culture proven active secondary infections 9. Participating in other drug clinical trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of moderate to severe COVID-19 patients achieving clinical improvement defined as a 2 point reduction in patientsâ?? admission status six-point ordinal scale or live discharge from the hospital, which ever come first.Timepoint: 28 days from the point of randomization. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of Participants Requiring Initiation of Invasive Ventilation Post-baseline 2. Ventilator-Free Days from Randomization to Day 28 3. Duration of CCU Stay in Days 4. Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of one-category worsening on the ordinal scale or Withdrawal (whichever occurs first) 5. Mortality Rate on Days 7, 14, 21, 28 Timepoint: 28 days from the point of randomization. | — |
Countries
India
Contacts
Public ContactDr Swati Datta
Medical College, Kolkata
Outcome results
None listed