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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

About this trial

This is an interventional treatment trial for Covid19

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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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