Cotrimoxazole in hospitalised patients with moderate to early-severe COVID-19 infectio

Phase 2

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

• Registration Number: CTRI/2020/10/028297
• Lead Sponsor: Dept of Health and Family Welfare Government of West Bengal

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

a. Adult individuals, age >18 and <65 years

b. COVID-19 infection documented by a positive RT-PCR test

c. Hospitalised patients with moderate to early-severe COVID-19 infection, characterized by

fever (at the time of screening or when admitted), oxygen saturation <= 94% on air at rest and requiring supplemental oxygen through mask or nasal cannula/catheter

d. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional)

e. Informed verbal consent under urgent conditions, documented in the electronically

Exclusion Criteria

a. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion.

b. AST/ALT values >5 fold the ULN.

c. Documented impairment of renal function

d. Absolute neutrophil count below 500 cells/mm3

e. Absolute platelet count below 50,000 cells/mm3

f. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection

g. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use

h. Pregnancy or lactation.

i. History of cotrimoxazole hypersensitivity

j. Patients participating in another clinical trial for SARS-CoV-2 infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified