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

NCT05056558 | Unknown Phase 3 DMC

• 1 other identifier: 2021/BR8/P3/01
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (1)

• 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: 1. Death 2. Hospitalized, on invasive mechanical ventilation or ECMO 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices 4. Hospitalized, requiring low flow supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care (other than per protocol Baricitinib administration) 7. Not hospitalized

  Day 1 to Day 14

Secondary Outcomes (1)

• The proportion of participants with treatment emergent adverse events

  Day 1 to Day 28

Other Outcomes (7)

• 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

Study Arms (2)

Baricitinib

EXPERIMENTAL

Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14

Drug: Baricitinib

Placebo

PLACEBO COMPARATOR

Continued SOC according as mentioned in operational definition in the protocol

Drug: Placebo

Interventions

Baricitinib DRUG

Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14

Also known as: Baricent

Baricitinib

Placebo DRUG

Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14

Also known as: Given Orally

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incepta Pharmaceuticals Ltd: lead

Study Sites (1)

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

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

COVID-19

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Md. Titu Miah, MBBS, FCPS

  Dhaka Medical College

  PRINCIPAL INVESTIGATOR

• Md. Mujibur Rahman, MBBS, MD

  Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md. Mujibur Rahman, MBBS, MD

CONTACT

+8801711-525406; mmrahman61@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2021
• First Posted: September 24, 2021
• Study Start: October 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: September 1, 2022
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

BA (1)