Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19 - A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial in Bangladesh
Trial Snapshot
- Phase
- Phase 3
- Sponsor
- Incepta Pharmaceuticals Ltd
- Enrollment
- 480
- Locations
- 1
- Primary Endpoint
- Clinical status assessed by a 7-point ordinal scale on Day 14
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Baricitinib
Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14
Intervention: Baricitinib (Drug)
Placebo
Continued SOC according as mentioned in operational definition in the protocol
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Clinical status assessed by a 7-point ordinal scale on Day 14
Time Frame: Day 1 to Day 14
The ordinal scale is an assessment of the clinical status at a given study day. Each day, the worst(ie, lowest ordinal) score from the previous day will be recorded, ie, on Day 3, the lowest ordinal score from Day 2 is obtained and recorded for Day 2. The scale is as follows: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol Baricitinib administration) 7. Not hospitalized
Secondary Outcomes
- The proportion of participants with treatment emergent adverse events(Day 1 to Day 28)