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

NCT05056558 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 480

Last updated 2021-09-28

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Incepta Pharmaceuticals Ltd

    lead INDUSTRY

Principal Investigators

  • Md. Titu Miah, MBBS, FCPS · Dhaka Medical College

  • Md. Mujibur Rahman, MBBS, MD · Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-31
Primary Completion
2022-04-30
Completion
2022-09-30

Countries

  • Bangladesh

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05056558 on ClinicalTrials.gov