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

Sponsor
Incepta Pharmaceuticals Ltd
Study ID
NCT05056558
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 31, 2021
Status verified
Sep 2021
Primary completion
Apr 30, 2022
Completion
Sep 30, 2022

Study Design

Enrollment
480 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Baricitinib
    Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14
  • Placebo Comparator: Placebo
    Continued SOC according as mentioned in operational definition in the protocol

Primary Outcome Measure

Clinical status assessed by a 7-point ordinal scale on Day 14 [ Time Frame: Day 1 to Day 14 ]

Central Contacts

Related Studies