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Cotrimoxazole in hospitalised patients with severe COVID-19 infection

Cotrimoxazole in hospitalised patients with severe COVID-19 infection compared to the standard of care â?? an investigator-initiated, randomised controlled trial (CoTroxCov Study)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/02/031012
Enrollment
200
Registered
2021-02-04
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Intervention1: Add-on oral cotrimoxazole: oral cotrimoxazole 960 mg three times daily for 7 days along with standard of care Control Intervention1: Standard of Care: Standard of Care

Sponsors

Dept of Health and Family Welfare Government of West Bengal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: a. Adult individuals, age >18 and 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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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 Day 7—

Secondary

MeasureTime frame
1. Changes in body temperature, respiratory rate, CRP, SpO2 2. Incidence of serious and non-serious adverse events Timepoint: Baseline Day 7—

Countries

India

Contacts

Public ContactBibhuti Saha

School of Tropical Medicine

bibhuti.saha@gmail.com9831296071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026