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

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19 - A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial in Bangladesh

Conditions
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Covid19

Intervention / Treatment
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* Drug: Baricitinib
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Baricitinib<br>Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14 | Drug: Baricitinib<br>* Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14<br>* Other names: Baricent;|
| Placebo Comparator: Placebo<br>Continued SOC according as mentioned in operational definition in the protocol | Drug: Placebo<br>* Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14<br>* Other names: Given Orally;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical status assessed by a 7-point ordinal scale on 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: Death Hospitalized, on invasive mechanical ventilation or ECMO Hospitalized, on non-invasive ventilation or high flow oxygen devices Hospitalized, requiring low flow supplemental oxygen Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol Baricitinib administration) Not hospitalized | Day 1 to Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of participants with treatment emergent adverse events |  | Day 1 to Day 28 |