Covid19Phase 3NCT05056558
Efficacy and Safety of Baricitinib in Patients With Moderate and Severe COVID-19
A Phase 3 study testing Baricitinib in people with Covid19, run by Incepta Pharmaceuticals Ltd at 1 site in Bangladesh.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Covid19
- What is being tested?
- Baricitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBangladesh
- Study dates
- 30 Jul 2020to 12 Apr 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Dhaka Medical College, Mugda Medical College, Kuwait Bangladesh Friendship Government Hospital
Dhaka
About this study
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
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
- Being tested
- Baricitinib, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaricitinibDrug
Also called Baricent
Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
PlaceboDrug
Also called Given Orally
Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14
| Study group | Role | What they receive |
|---|---|---|
| Baricitinib | Experimental | Continued SOC together with oral 4 mg Baricitinib from day 1 to day 14 Receives: Drug: Baricitinib |
| Placebo | Placebo comparator | Continued SOC according as mentioned in operational definition in the protocol Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1 to Day 14
Secondary outcomes (1)
The proportion of participants with treatment emergent adverse events
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2021
- Study start30 Jul 2020 (estimated)
- Primary completion30 Jul 2025 (estimated)
- Study completion12 Apr 2026 (estimated)
Why it stopped: The study was planned during COVID-19 outbreak to assess Baricitinib in Patients With Moderate and Severe COVID-19. The study could not be started due to many obstacle which was raised because of Pandemic. The study is no more relevant.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incepta Pharmaceuticals Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Md. Titu Miah, MBBS, FCPS, Principal investigator, Dhaka Medical CollegeMd. Mujibur Rahman, MBBS, MD, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05056558
- Sponsor's protocol ID
- 2021/BR8/P3/01
- Status last verified
- Nov 2026
- First submitted
- 20 Sep 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05056558
- Acronym / sponsor ID
- 2021/BR8/P3/01
- Conditions
- Covid19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study was planned during COVID-19 outbreak to assess Baricitinib in Patients With Moderate and Severe COVID-19. The study could not be started due to many obstacle which was raised because of Pandemic. The study is no more relevant.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Incepta Pharmaceuticals LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Jul 2020 (estimated)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 12 Apr 2026 (estimated)
- First posted
- 24 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Baricitinib | Experimental | Drug: BaricitinibContinued SOC together with oral 4 mg Baricitinib from day 1 to day 14 |
| Placebo | Placebo comparator | Drug: PlaceboContinued SOC according as mentioned in operational definition in the protocol |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BaricitinibAlso: BaricentContinued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14 | Drug | Baricitinib |
| PlaceboAlso: Given OrallyContinued standard of care (SOC) together with oral placebo tablet from day 1 to day 14 | Drug | Placebo |
Primary outcome
Clinical status assessed by a 7-point ordinal scale on Day 14
Time frame: Day 1 to 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
1 secondary outcome
The proportion of participants with treatment emergent adverse events
Time frame: Day 1 to Day 28
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Md. Titu Miah, MBBS, FCPS principal investigator
Dhaka Medical College
Md. Mujibur Rahman, MBBS, MD principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Baricitinib in people with Covid19, run by Incepta Pharmaceuticals Ltd at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical status assessed by a 7-point ordinal scale on Day 14 (time frame: Day 1 to Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.