Cotrimoxazole in hospitalised patients with severe COVID-19 infectio
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
- Registration Number
- CTRI/2021/02/031012
- Lead Sponsor
- Dept of Health and Family Welfare Government of West Bengal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
a. Adult individuals, age >18 and <65 years
b. COVID-19 infection documented by a positive RT-PCR test
c. Hospitalised patients with severe COVID-19 infection, characterized by
fever (at the time of screening or when admitted) and requiring supplemental oxygen through non- re-breath mask between 10L-15L/ min.
d. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional)
e. Informed verbal consent under urgent conditions, documented in the electronically
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
- Primary Outcome Measures
Name Time Method 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/ ><br>Day 7
- Secondary Outcome Measures
Name Time Method 1.Changes in body temperature, respiratory rate, CRP, SpO2 <br/ ><br>2.Incidence of serious and non-serious adverse events <br/ ><br>Timepoint: Baseline <br/ ><br>Day 7