COVID-19 trials registries data warehouse

http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51954

Bibhuti Saha

bibhuti.saha@gmail.com

2021-02-04

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 severe COVID-19 infection, characterized by <br/ >fever (at the time of screening or when admitted) and requiring supplemental oxygen through non- re-breath mask between 10L-15L/ min. <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

19

64

India

Severe disease at enrollment

6: Severe disease at enrollment

200

Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7)Timepoint: Baseline <br/ >Day 7

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

Not reported

[{"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"}]