COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49731

Dr Swati Datta

drslahiri11@gmail.com

2020-12-07

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

Patients with moderate to severe COVID-19 disease with following criteria : <br/ >1. Age >18 years <br/ >2. Laboratory confirmed COVID-19 patients <br/ >3. SpO2 94% <br/ >4. Patients on different modalities of oxygen therapy <br/ >5. Patients with radiologically confirmed pneumonia <br/ >6. ARDS / Acute Respiratory Failure <br/ >Presence of raised inflammatory markers e.g. CRP, ferritin, IL-6 <br/ >

Patients with moderate to severe COVID-19 disease with following criteria : <br/ >1. Pregnancy or breast feeding <br/ >2. Serum alanine aminotransferase(ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) <br/ >3. Known severe renal impairment (eGFR ï?¼30 ml/min/1.73 m2 or on continuous RRT (hemodialysis, peritoneal dialysis) <br/ >4. Known severe allergic reactions to tocilizumab or other monoclonal antibodies <br/ >5. Known hypersensitivity to remdesivir <br/ >6. Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months <br/ >7. Absolute neutrophil count (ANC) < 1000/uL at screening <br/ >8. Clinical evidence of active tuberculosis or blood culture proven active secondary infections <br/ >9. Participating in other drug clinical trials <br/ >

2

Dr Swati Datta

19

100

India

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

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.

| Declared number of arm (2.0) differs from found arms (3.0)

Not reported

[{"arm_notes": "", "treatment_id": 1689, "treatment_name": "Remdesivir+tocilizumab", "treatment_type": "Antivirals+interleukin inhibitors", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 1099, "treatment_name": "Remdesivir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}]