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Evaluation of the efficacy and safety of Co-trimoxazole in patients with COVID-19

Evaluation of the efficacy and safety of Co-trimoxazole in patients with COVID-19: A randomized open-label clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220407054446N1
Enrollment
60
Registered
2022-05-22
Start date
2022-04-19
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Coronavirus disease (COVID-19). Severe acute respiratory syndrome [SARS]

Interventions

Intervention 1: Intervention group: Co-trimoxazole, along with standard treatment, will be administered at a dose of 960 mg (2 tablets of 480 mg) twice a day for 7 days. Intervention 2: Control group:

Sponsors

Bandare-abbas University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 18 years or older Conscious and voluntary satisfaction Definitive diagnosis of COVID-19 disease by PCR test Hospitalized with early sign of moderate disease

Exclusion criteria

Exclusion criteria: Multiple organ failure Severe ARDS Septic shock Acute kidney injury (which GFR is <15) Drug allergy / Sensitivity to drugs with sulfuric structure / Intolerance to co-trimoxazole Women during pregnancy and lactation, taking other antiviral drugs, tocilizumab or plasma therapy

Design outcomes

Primary

MeasureTime frame
Reduction of viral load at the end of the study. Timepoint: At the end of the seventh day or discharge time. Method of measurement: PCR(Polymerase Chain Reaction) test.;Improvement of clinical symptoms during the intervention period (improvement of clinical symptoms as continuous improvement (more than 72 hours). Timepoint: Daily follow up and repeated measurements are performed at least twice per follow up. Method of measurement: Oral temperature = 36.6 °C; respiratory frequency =24 times per minute; and oxygen saturation =98% without mechanical respiration. In addition, the need for oxygen therapy and ventilation with non-invasive positive pressure in daily follow up along with other clinical symptoms such as cough, muscle pain, headache, shortness of breath, weakness and lethargy, decreased sense of smell and taste, diarrhea, abdominal spasm, nausea and vomiting are recorded qualitatively.

Secondary

MeasureTime frame
Length of hospital stay. Timepoint: Beginning of study and end of study (day 7 of study or discharge time). Method of measurement: CBC tests, subtraction count of white cells, ferritin, CRP, LDH, ESR, creatinine and serum nitrogen urea.;Need to be admitted to the intensive care unit. Timepoint: Beginning of study and end of study (day 7 of study or discharge time). Method of measurement: CBC tests, subtraction count of white cells, ferritin, CRP, LDH, ESR, creatinine and serum nitrogen urea.;Improvement of biochemical parameters of patients. Timepoint: Beginning of study and end of study (day 7 of study or discharge time). Method of measurement: CBC tests, subtraction count of white cells, ferritin, CRP, LDH, ESR, creatinine and serum nitrogen urea.;Side effects of the drugs studied. Timepoint: Side effects are recorded daily in the studied groups. Method of measurement: Side effects of the studied drugs, especially those such as hypersensitivity reactions, allergies, doubts, anemia, hypotension, nausea and vomiting, diarrhea, gastrointestinal spasms, weakness and lethargy, headache, and rash), frequency of possible side effects due to intervention and frequency of withdrawal due to side effects are recorded daily in the studied groups.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Sahar Defaei

Bandare-abbas University of Medical Sciences

Sahardefaee137397@gmail.com+98 76 3334 7000

Outcome results

None listed

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