Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19
Primary Purpose
Covid19
Status
Unknown status
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
Baricitinib
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
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
Sites / Locations
- Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Baricitinib
Placebo
Arm Description
Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14
Continued SOC according as mentioned in operational definition in the protocol
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
The proportion of participants with treatment emergent adverse events
Full Information
NCT ID
NCT05056558
First Posted
September 20, 2021
Last Updated
September 25, 2021
Sponsor
Incepta Pharmaceuticals Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05056558
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
April 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incepta Pharmaceuticals Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Baricitinib
Arm Type
Experimental
Arm Description
Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Continued SOC according as mentioned in operational definition in the protocol
Intervention Type
Drug
Intervention Name(s)
Baricitinib
Other Intervention Name(s)
Baricent
Intervention Description
Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Given Orally
Intervention Description
Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14
Primary Outcome Measure Information:
Title
Clinical status assessed by a 7-point ordinal scale on Day 14
Description
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
Time Frame
Day 1 to Day 14
Secondary Outcome Measure Information:
Title
The proportion of participants with treatment emergent adverse events
Time Frame
Day 1 to Day 28
Other Pre-specified Outcome Measures:
Title
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
Title
Time to ≥ 1-point improvement (days) from baseline clinical status
Time Frame
Day 1 to Day 28
Title
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
Title
Duration of oxygen therapy (days)
Time Frame
Day 1 to Day 28
Title
Proportion of patients with shift in oxygen support status from baseline
Time Frame
Day 1 to Day 28
Title
Duration of hospitalization (days)
Time Frame
Day 1 to Day 28
Title
Number of patients with all-cause mortality at Day 28
Time Frame
Day 1 to Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Md. Mujibur Rahman, MBBS, MD
Phone
+8801711-525406
Email
mmrahman61@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Md. Titu Miah, MBBS, FCPS
Organizational Affiliation
Dhaka Medical College
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Md. Mujibur Rahman, MBBS, MD
Organizational Affiliation
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital
City
Dhaka
Country
Bangladesh
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19
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