COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48268

Dr Santanu Kumar Tripathi

tripathi.santanu@gmail.com

2020-10-08

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Treatment

a. Adult individuals, age >18 and <65 years <br/ >b. COVID-19 infection documented by a positive RT-PCR test <br/ >c. Hospitalised patients with moderate to early-severe COVID-19 infection, characterized by <br/ >fever (at the time of screening or when admitted), oxygen saturation â?¤ 94% on air at rest and requiring supplemental oxygen through mask or nasal cannula/catheter <br/ >d. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional) <br/ >e. Informed verbal consent under urgent conditions, documented in the electronically <br/ >

a. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion. <br/ >b. AST/ALT values >5 fold the ULN. <br/ >c. Documented impairment of renal function <br/ >d. Absolute neutrophil count below 500 cells/mm3 <br/ >e. Absolute platelet count below 50,000 cells/mm3 <br/ >f. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection <br/ >g. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use <br/ >h. Pregnancy or lactation. <br/ >i. History of cotrimoxazole hypersensitivity <br/ >j. Patients participating in another clinical trial for SARS-CoV-2 infection <br/ >

2

Dept of Health and Family Welfare Government of West Bengal

18

65

India

Severe disease at enrollment

6: Severe disease at enrollment

200

a. Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline <br/ >b. Duration of hospitalisation: Days from the date of enrolment to the date of discharge <br/ >c. Number of in-patient deaths <br/ >Timepoint: Till Discharge

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

Phase 2

[{"arm_notes": "", "treatment_id": 331, "treatment_name": "Cotrimoxazole", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]