NCT05056558

Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19

Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19 - A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial in Bangladesh

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 480 (estimated)
• Sponsor: Incepta Pharmaceuticals Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is multicenter clinical trial to evaluate efficacy and safety of Baricitinib in treatment for COVID-19. This trial will compare Baricitinib, a drug recommended for Rheumatoid Arthritis, against standard of care, to assess its relative effectiveness against COVID-19. By enrolling patients in multiple centers, this trial aims to recruit more patients to evaluate whether this drug slow disease progression or improve survival. Currently no effective therapeutics treatment or vaccine is available in the world for this highly transmissible respiratory borne infection, Covid-19. A number of drug trials are ongoing to measure the efficacy of the drug against the virus. Bangladesh as a resource limited country with limitation to provided health care services to the huge number of Covid-19 patients who will need hospitalization will be benefited from this study. There is no physical, psychological, social, legal risk in this study. The trial therapeutic will be approved form the Directorate of drug Administration (DGDA), Bangladesh.

Conditions

• Covid19

Interventions

Type	Name	Description
DRUG	Baricitinib	Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
DRUG	Placebo	Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-04-01
• Completion: 2022-09-01
• First posted: 2021-09-24
• Last updated: 2021-09-28

Locations

1 site across 1 country: Bangladesh