NCT04470531

Role of Co-trimoxazole in Severe COVID-19 Patients

Status unknown Phase 2 Last updated 16 July 2020

What this trial tests

Phase 2 trial testing oral co-trimoxazole in Covid19 in 94 participants. Status unknown.

Timeline

12 July 2020

Primary endpoint
12 October 2020

30 January 2021

Quick facts

Lead sponsor	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	94
Start date	12 July 2020
Primary completion	12 October 2020
Estimated completion	30 January 2021
Sites	1 location across Bangladesh

Drugs / interventions tested

• oral co-trimoxazole — full drug profile →

Conditions studied

• Covid19 — all drugs for Covid19 →
• Severe COVID-19 Patients — all drugs for Severe COVID-19 Patients →

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Who can join

Adults 18 to 70, any sex, with Covid19 or Severe COVID-19 Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibiotics for the treatment of COVID-19.
   Popp M, Stegemann M, Riemer M, Metzendorf MI, et al · · 2021 · cited 60× · PMID 34679203 · DOI 10.1002/14651858.cd015025
2. Description and Analysis of Cytokine Storm in Registered COVID-19 Clinical Trials: A Systematic Review.
   Eljaaly K, Malibary H, Alsulami S, Albanji M, et al · · 2021 · cited 11× · PMID 34199506 · DOI 10.3390/pathogens10060692