Role of Co-trimoxazole in Severe COVID-19 Patients
Status:
Recruiting
Trial end date:
2021-01-30
Target enrollment:
Participant gender:
Summary
Coronavirus Disease 19 (COVID-19) is a global pandemic caused by Severe Acute Respiratory
Syndrome Coronavirus 2 (SARS-CoV-2). Severe disease occurs in 15% of the cases with COVID-19
and may progress to critical disease in only 5% of the cases with a high risk of mortality.
Critical disease may present as acute respiratory failure secondary to Acute Respiratory
Distress Syndrome (ARDS) and is caused by the body's hyper-immune response to the virus in
the form of a cytokine storm syndrome (CSS). There is currently no effective anti-viral
treatment against SARS-CoV-2 and the mainstay of treatment is supportive. Co-trimoxazole
(combination of trimethoprim and sulphamethoxazole in a 1:5) ratio is a Sulphur containing
anti-folate bactericidal antibiotic indicated for the treatment of respiratory tract
infections. It has been around for over 60 years and is inexpensive and readily available
with a good safety profile. It has a rapid onset of action with excellent bioavailability and
lung penetration. In addition to having antimicrobial properties co-trimoxazole have
immunomodulatory and anti-inflammatory properties and may be a potential treatment option for
cytokine storm syndrome mediated severe COVID-19.
This open-label randomized controlled trial will be conducted in the department of medicine
at Bangabandhu Sheikh Mujib Medical University (BSMMU), Anwar Khan Modern Medical college and
Mughda Medical College Hospital (DMCH), Dhaka for a duration of 6 months following approval
of this protocol. It will recruit at least 94 consecutive adults (18 years or older) patients
with clinically suspected COVID-19 and severe illness as per WHO criteria. After taking
informed written consent patients will be randomly assigned in a 1:1 ratio to either oral
co-trimoxazole in addition to standard therapy or standard therapy alone. Baseline
characteristics, changes in the physiological and biochemical parameters like (SpO2/FiO2
ratio, respiratory rate, body temperature and C - reactive protein), length of hospital stay,
side effects of drugs, requirement for ventilatory support (non-invasive and invasive
ventilation) and in-patient mortality between the two groups will be compared.
Conclusion If the results from this clinical trial demonstrate the beneficial effects of
co-trimoxazole in severe COVID-19 patients it could be used widely, thereby reducing the need
for respiratory support and potentially saving thousands of lives in developing nations with
limited resources where healthcare may be easily overwhelmed.
Phase:
Phase 2
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Collaborators:
Anwar Khan Mordern Medical College and Hospital, Dhaka Mugda Medical College and Hospital, Dhaka