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

Incepta Pharmaceuticals

Status and phase: Unknown; Phase 3

Conditions: Covid19

Treatments: Drug: Placebo; Drug: Baricitinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT05056558

2021/BR8/P3/01

Details and patient eligibility

About

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.

Enrollment: 480 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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480 participants in 2 patient groups, including a placebo group

Baricitinib

Experimental group

Description:

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

Treatment:

Drug: Baricitinib

Placebo

Placebo Comparator group

Description:

Continued SOC according as mentioned in operational definition in the protocol

Treatment:

Drug: Placebo