A Phase 3 interventional study of Baricitinib and Placebo in Covid19, sponsored by Incepta Pharmaceuticals Ltd. Status unknown at 1 site in Bangladesh. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-09-28.
Sponsored by Incepta Pharmaceuticals Ltd · Phase 3, Interventional, and Treatment
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 480 is above the median of 100 across 4,098 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Incepta Pharmaceuticals Ltd is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14
Drug: Baricitinib
Continued SOC according as mentioned in operational definition in the protocol
Drug: Placebo
Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
Also known as: Baricent
Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14
Also known as: Given Orally
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: 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
Time frame: Day 1 to Day 14
The proportion of participants with treatment emergent adverse events
Time frame: Day 1 to Day 28
Time to clinical improvement (days): clinical improvement is defined as a ≥ 2-point improvement in clinical status (7-point ordinal scale) from Day 1
Time frame: Day 1 to Day 28
Time to ≥ 1-point improvement (days) from baseline clinical status
Time frame: Day 1 to Day 28
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
Time frame: Day 1 to Day 28
Duration of oxygen therapy (days)
Time frame: Day 1 to Day 28
Proportion of patients with shift in oxygen support status from baseline
Time frame: Day 1 to Day 28
Duration of hospitalization (days)
Time frame: Day 1 to Day 28
Number of patients with all-cause mortality at Day 28
Time frame: Day 1 to Day 28
This study is status unknown, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
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Incepta Pharmaceuticals Ltd