Baricitinib in Hospitalized Covid-19 Patients With Diabetes Mellitus
Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
To date, some of the most promising drugs used in the treatment of COVID pneumonia are
systemic corticosteroids, remdesivir and baricitinib. Dexamethasone has been found
efficacious in reducing mortality in patients requiring supplemental oxygen and mechanical
ventilation. There is a trend towards reduced mortality in patients who receive remdesivir
and dexamethasone combination, supporting the hypothesis that an antiviral drug combined with
an anti-inflammatory agent improve outcomes in COVID-19. Baricitinib plus remdesivir is
superior to remdesivir alone in reducing recovery time and accelerating improvement in
clinical status among patients with COVID-19, notably among those receiving high-flow oxygen
non-invasive ventilation. Diabetes mellitus increases the risk for COVID-19 morbidity and
mortality. Patients with diabetes have coexisting morbidities and already immune-compromised.
Steroids cause further immunosuppression and may contribute to uncontrolled blood glucose in
this group of patients, resulting in worse outcomes. Baricitinib can be an alternative to
corticosteroids in diabetic patients. This open-label multi-centre non-inferiority randomized
controlled trial will be conducted in seven hospitals in Bangladesh. The primary objective is
to evaluate the clinical efficacy of baricitinib plus remdesivir compared to dexamethasone
plus remdesivir in hospitalized COVID-19 patients with diabetes mellitus, as assessed by the
proportion of patients, need "rescue treatment" between two groups by day 29. Hospitalized
adult (≥18 years) diabetic patients with confirmed SARS-CoV-2 infection have ordinal scale
category 5 will be included in the study. Subjects will be randomized in a 1:1 (by tossing a
coin) ratio in two groups. The total sample size is 362. Group 1 subjects will receive 200 mg
of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily dose of
remdesivir while hospitalized for up to 5 days and 4 mg of baricitinib administered as 2
tablets taken orally daily while hospitalized for up to 14 days. Group 2 will receive the
same dose of remdesivir plus 6 mg of dexamethasone administered as an intravenous injection
daily while hospitalized for up to 10 days. Subjects will be assessed daily while
hospitalized. Discharged subjects will be evaluated on days 15, 22 and 29 (in person; if not
possible, over the telephone). Assessment will be done clinically using an 8-point Ordinal
Scale and National Early Warning Score.
Phase:
Phase 3
Details
Lead Sponsor:
Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders