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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2020/10/028297

Enrollment

200

Registered

2020-10-08

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: cotrimoxazole plus standard of care: Patients will receive oral cotrimoxazole 960 mg twice daily for 7 days Control Intervention1: Routine Care: drugs or procedures in routine clinical

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 moderate to early-severe COVID-19 infection, characterized by fever (at the time of screening or when admitted), oxygen saturation 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

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

Secondary

Measure	Time frame
1. Changes in body temperature, respiratory rate, CRP, SpO2 2. Incidence of serious and non-serious adverse events Timepoint: Till Discharge	—

Countries

India

Contacts

Public ContactDr Santanu Kumar Tripathi

School of Tropical Medicine

tripathi.santanu@gmail.com9230566771

Outcome results

None listed

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