Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19

Covid19 Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05056558
• Other study ID #: 2021/BR8/P3/01
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: October 2021
• Est. completion date: September 2022

Study information

• Verified date: September 2021
• Source: Incepta Pharmaceuticals Ltd
• Contact: Md. Mujibur Rahman, MBBS, MD
• Phone: +8801711-525406
• Email: mmrahman61[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: September 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Covid19

Intervention

Drug:
• Baricitinib
Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
• Placebo
Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14

Locations

Country	Name	City	State
Bangladesh	Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Incepta Pharmaceuticals Ltd

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Time to = 1-point improvement (days) from baseline clinical status		Day 1 to Day 28
Other	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
Other	Duration of oxygen therapy (days)		Day 1 to Day 28
Other	Proportion of patients with shift in oxygen support status from baseline		Day 1 to Day 28
Other	Duration of hospitalization (days)		Day 1 to Day 28
Other	Number of patients with all-cause mortality at Day 28		Day 1 to Day 28
Primary	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	Day 1 to Day 14
Secondary	The proportion of participants with treatment emergent adverse events		Day 1 to Day 28