Clinical trial NCT05056558: Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19
Official title: Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19 - A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial in Bangladesh
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
Lead sponsor: Incepta Pharmaceuticals Ltd
Sponsor class: INDUSTRY
First posted: 2021-09-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical status assessed by a 7-point ordinal scale on Day 14
timeFrame: Day 1 to Day 14
Secondary outcomes:
measure: The proportion of participants with treatment emergent adverse events
timeFrame: Day 1 to Day 28
Other outcomes:
measure: Time to clinical improvement (days): clinical improvement is defined as a ≥ 2-point improvement in clinical status (7-point ordinal scale) from Day 1
timeFrame: Day 1 to Day 28
measure: Time to ≥ 1-point improvement (days) from baseline clinical status
timeFrame: Day 1 to Day 28
measure: 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
timeFrame: Day 1 to Day 28
measure: Duration of oxygen therapy (days)
timeFrame: Day 1 to Day 28
measure: Proportion of patients with shift in oxygen support status from baseline
timeFrame: Day 1 to Day 28
measure: Duration of hospitalization (days)
timeFrame: Day 1 to Day 28
measure: Number of patients with all-cause mortality at Day 28
timeFrame: Day 1 to Day 28
Locations:
city: Dhaka
country: Bangladesh
facility: Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital
Study officials:
affiliation: Dhaka Medical College
name: Md. Titu Miah, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
name: Md. Mujibur Rahman, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
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