The Role of High Dose Co-trimoxazole in Severe Covid-19 Patients
Status:
Not yet recruiting
Trial end date:
2021-11-14
Target enrollment:
Participant gender:
Summary
Coronavirus Disease 19 (COVID-19) is a worldwide pandemic and a major global health concern
which is caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). The newly
emerged Coronavirus disease 2019 (COVID-19), which was first identified in Wuhan, China, has
swept through 219 countries, killing a staggering number of people. According to WHO reports,
the number of deaths had risen to 3,155,168by March 30, 2021, out of 149,910,744 confirmed
cases. In Bangladesh, the outbreak has infected over 745,322confirmed cases, with over 11,053
deaths reported. Though the patient may be asymptomatic or present with mild symptoms,
mortality is quite high in the severe form of the disease which often progresses to critical
phase presented as Acute Respiratory Distress Syndrome (ARDS). This is due to exaggerated
response of immune system to the virus termed as cytokine storm syndrome (CSS). There is
currently no effective antiviral therapy for SARS-CoV-2 and supportive care is the mainstay
of therapy. As a result we are still searching for a better therapeutic agent which will help
in treating Covid-19 cases in terms of mortality, morbidity, oxygen requirement, length of
stay in hospital. Co-trimoxazole (composed of one-part Trimethoprim and five parts
Sulfamethoxazole)is a sulphur containing anti-folate bactericidal drug which is being used
for over 60 years for various indications esp. respiratory tract infections. It is known to
have immunomodulatory and anti-inflammatory properties that may help to prevent progression
to critical phase and cytokine storm syndrome in severe COVID-19 patients. It acts rapidly
when given in high dose due to its better bioavailability and lung penetration. Low cost and
a good safety profile can make it an ideal candidate for treatment of COVID -19 in a low
resource country like Bangladesh.
Methods and materials:
This interventional double-blind place controlled randomized trial will be conducted in the
department of medicine at Bangabandhu Sheikh Mujib Medical University (BSMMU) 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 high dose co-trimoxazole in addition to standard therapy or
placebo along with standard therapy. 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 28- day mortality between the
two groups will be compared. Data will be collected from case record forms, anonymised and
stored securely in a secure online web based portal. Statistical analysis will be performed
using t-test or Mann -Whitney U test or Wilcoxon signed rank test for continuous variables
and Chi- square test or Fisher's exact test for categorical variables. Survival will be
assessed by the Kaplan-Meier method. Comparisons between two groups will be performed using
the log-rank test. A p-value of < 0.05 will be considered to be significant. The statistical
software SPSS version 25 will be used for the analysis.
Conclusion If the results from this clinical trial demonstrate the beneficial effects of high
co-trimoxazole in patients with severe COVID-19 it could help to reduce the need for
respiratory support for thousands of patients, saving valuable lives and decrease the burden
of healthcare system in countries with limited resources.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh