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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baricitinib | Experimental | Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14 |
|
| Placebo | Placebo Comparator | Continued SOC according as mentioned in operational definition in the protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baricitinib | Drug | Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14 |
|
| 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:
| Day 1 to Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants with treatment emergent adverse events | Day 1 to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to clinical improvement (days): clinical improvement is defined as a ≥ 2-point improvement in clinical status (7-point ordinal scale) from Day 1 | Day 1 to Day 28 | |
| Time to ≥ 1-point improvement (days) from baseline clinical status | Day 1 to Day 28 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Md. Mujibur Rahman, MBBS, MD | Contact | +8801711-525406 | mmrahman61@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Md. Titu Miah, MBBS, FCPS | Dhaka Medical College | Principal Investigator |
| Md. Mujibur Rahman, MBBS, MD | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital | Dhaka | Bangladesh |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000596027 | baricitinib |
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| Placebo | Drug | Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14 |
|
|
| Time to recovery: defined as an improvement in clinical status from a baseline score of 2 through 5 to a score of 6 or 7, or an improvement from a baseline score of 6 to a score of 7 | Day 1 to Day 28 |
| Duration of oxygen therapy (days) | Day 1 to Day 28 |
| Proportion of patients with shift in oxygen support status from baseline | Day 1 to Day 28 |
| Duration of hospitalization (days) | Day 1 to Day 28 |
| Number of patients with all-cause mortality at Day 28 | Day 1 to Day 28 |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |