Remdesivir plus Tocilizumab efficacy trial in moderate to severe COVID-19 patients

Not Applicable

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2020/12/029615
• Lead Sponsor: Dr Swati Datta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

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) < 1000/uL at screening

8. Clinical evidence of active tuberculosis or blood culture proven active secondary infections

9. Participating in other drug clinical trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
1. Proportion of Participants Requiring Initiation of Invasive Ventilation Post-baseline <br/ ><br>2. Ventilator-Free Days from Randomization to Day 28 <br/ ><br>3. Duration of CCU Stay in Days <br/ ><br>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) <br/ ><br>5. Mortality Rate on Days 7, 14, 21, 28 <br/ ><br>Timepoint: 28 days from the point of randomization.