|D045169||Severe Acute Respiratory Syndrome NIH||0.05|
|D018352||Coronavirus Infections NIH||0.04|
There is one clinical trial.
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.
Description: Duration of hospital stay in daysMeasure: Length of stay in hospital (in days) Time: 14 days
Description: % of patients died after enrollmentMeasure: In-patient mortality Time: 14 days
Description: ratio of Saturation of oxygen in % and Fraction of inspired oxygenMeasure: SpO2/FiO2 ratio Time: Day 1,2,3,4 and 5
Description: Respiratory rate per minuteMeasure: respiratory rate Time: Day 1,2,3,4 and 5
Description: CRP level in mg/litreMeasure: C-reactive Protein Time: Day 1,2,3,4 and 5
Description: Temperature in degree FahrenheitMeasure: Fever Time: Day 1,2,3,4 and 5
Description: Requirement of ventilator support in hoursMeasure: Ventilator support Time: 14 days
Description: % of patients developed early reaction like fever, rash, abdominal pain, urticaria, vomiting, wheezing, chest tightnessMeasure: Proportion of drug adverse reaction Time: 24 hours