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

Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19 - A Multicenter Randomized Double Blind Placebo Controlled Clinical Trial in Bangladesh

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Covid19
• Intervention / Treatment: Drug: Baricitinib; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 480
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Md. Mujibur Rahman, MBBS, MD; Phone Number: +8801711-525406; Email: mmrahman61@gmail.com

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Baricitinib; Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14	Drug: Baricitinib; Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14; Other Names: Baricent
Placebo Comparator: Placebo; Continued SOC according as mentioned in operational definition in the protocol	Drug: Placebo; Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14; Other Names: Given Orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
The proportion of participants with treatment emergent adverse events	Day 1 to Day 28

Other Outcome Measures

Outcome Measure	Time Frame
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
Time to ≥ 1-point improvement (days) from baseline clinical status	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	Day 1 to Day 28
Duration of oxygen therapy (days)	Day 1 to Day 28
Proportion of patients with shift in oxygen support status from baseline	Day 1 to Day 28
Duration of hospitalization (days)	Day 1 to Day 28
Number of patients with all-cause mortality at Day 28	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Incepta Pharmaceuticals Ltd
• Investigators: Principal Investigator: Md. Titu Miah, MBBS, FCPS, Dhaka Medical College; Principal Investigator: Md. Mujibur Rahman, MBBS, MD, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: September 23, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 25, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2021/BR8/P3/01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No