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

NCT ID: NCT05056558

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 480 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-31
• Study Completion Date: 2022-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Baricitinib

Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14

Group Type: EXPERIMENTAL

Baricitinib

Intervention Type: DRUG

Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14

Placebo

Continued SOC according as mentioned in operational definition in the protocol

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14

Interventions

Baricitinib

Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14

Intervention Type: DRUG

Placebo

Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14

Intervention Type: DRUG

Other Intervention Names

Baricent; Given Orally

Eligibility Criteria

Inclusion Criteria

• SARS-Co-V2 positivity to the nasal-swab by reverse-transcriptase-polymerase chain- reaction (RT-PCR) assay tested by the local diagnostic laboratory
• Age >18 years
• Presence of any symptoms suggestive of COVID-19, such as such as fever, fatigue, cough (with or without sputum production), shortness of breath, sore throat, nasal congestion, anorexia, malaise, or headache. Rarely, patients may also present with diarrhea, nausea, and vomiting
• Presence of radiological findings of pneumonia assessed by chest radiograph, computed tomography
• Moderate and severe COVID-19 as per previous definition national guideline/WHO
• Give informed written consent

Exclusion Criteria

• Absolute lymphocyte count <500/mm3 and absolute neutrophil count of <1000/mm3 and Hemoglobin 8gm/dl or less
• Severe hepatic or renal impairment
• Live vaccine within 3 months prior to first dose of the drug
• Pregnancy
• Lactation
• Current malignancy or history of malignancies over the previous 5 years and/or history of malignancies in first degree relatives
• Transaminases values 5-fold higher than the upper normal limit
• Proven evidence of concomitant bacterial infections
• Clinical evidences suggestive of pulmonary tuberculosis, or past history and/or history of contact with TB patient
• Known hypersensitivity to Baricitinib
• Those who have received Tocilizumab previously

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incepta Pharmaceuticals Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Md. Titu Miah, MBBS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Dhaka Medical College

Md. Mujibur Rahman, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Locations

Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital

Dhaka, , Bangladesh

Countries

Bangladesh

Central Contacts

Md. Mujibur Rahman, MBBS, MD

Role: CONTACT

mmrahman61@gmail.com

+8801711-525406

Other Identifiers

2021/BR8/P3/01

Identifier Type: -

Identifier Source: org_study_id