Covid19Phase 3NCT04693026
Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients
A Phase 3 study testing Remdesivir, Baricitinib and Tocilizumab in people with Covid19 and Covid-19 ARDS, run by M Abdur Rahim Medical College and Hospital at 1 site in Bangladesh.
Trial summary
This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19, Covid-19 ARDS
- What is being tested?
- Remdesivir, Baricitinib and Tocilizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteBangladesh
- Study dates
- 10 Sep 2020to 5 Mar 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Who cannot join
- Participants with uncontrolled clinical status who were hospitalized from the before. Contraindication / possible drug interaction. Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/ renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site, 1 recruiting
- Recruiting
M. Abdur Rahim Medical College Hospital
Dinajpur, 5200
Akter Kamal, MD, PhD, 0088017233991, kamalaktar@yahoo.com
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, 008801817711079, dr_mohiuddinchy@yahoo.com
About this study
Official title: Efficacy of Ramdicivir and Baricitinib Combination Therapy for the Treatment of COVID 19 ARDS
This study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients.
- Conditions
- Covid19, Covid-19 ARDS
- Being tested
- Remdesivir, Baricitinib, Tocilizumab
- Keywords
- COVID 19, Covid-19 ARDS, Tocilizumab, Remdicivir, Baricitinib
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
Also called Ninavir
Remdesivir 100 IV Infusion as a lyophilized powder
BaricitinibDrug
Baricitinib oral tablet form
TocilizumabDrug
Tocilizumab IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| Group A: Remdesivir + Baricitinib treatment group | Experimental | Remdesivir (Injectable solution):
A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization.
+
Baricitinib (oral tablet form):
Baricitinib tablets 4 mg/day for 2 to 4weeks Receives: Drug: Remdesivir; Drug: Baricitinib |
| Group B: Remdesivir + Tocilizumab treatment group | Active comparator | Remdesivir (Injectable solution) A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization.
+
Tocilizumab (Injectable solution):
Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart. Receives: Drug: Remdesivir; Drug: Tocilizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Improvement (TTCI)
Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours.
Measured: Following randomization 30 days
Secondary outcomes (5)
Mortality Rate
Mortality Rate on Days during hospitalization
Measured: Following randomization 30 days.
Duration of ICU stay
Duration of ICU Stay in days.
Measured: Following randomization 30 days.
Duration total hospital stay
Duration of hospital stay in days.
Measured: Following randomization 30 days.
Rate of daily Supplemental Oxygen Use
Rate of daily Supplemental Oxygen Use by the patient
Measured: Following randomization 30 days.
Time to Clinical Failure
Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation, ICU Admission, or Withdrawal (whichever occurs first)
Measured: Following randomization 30 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2021
- Study start10 Sep 2020
- Primary completion15 Feb 2021 (estimated)
- Study completion5 Mar 2021 (estimated)
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
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M Abdur Rahim Medical College and Hospital
- Sponsor type
- Other government
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Responsible party
- Principal investigator, Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University
- Investigators
- Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD, Study chair, First Affiliated Hospital Xi'an Jiaotong UniversityAkter Kamal, MD, PhD, Study director, M Abdur Rahim Medical College and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04693026
- Sponsor's protocol ID
- M.A.R.M.C.D./2020/2637
- Status last verified
- Dec 2020
- First submitted
- 30 Dec 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ramdicivir and Baricitinib Combination Therapy for the Treatment of COVID 19 ARDS
- ClinicalTrials.gov ID
- NCT04693026
- Acronym / sponsor ID
- M.A.R.M.C.D./2020/2637
- Conditions
- Covid19, Covid-19 ARDS
- Keywords
- COVID 19, Covid-19 ARDS, Tocilizumab, Remdicivir, Baricitinib
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M Abdur Rahim Medical College and HospitalOther government
- Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
- Study start
- 10 Sep 2020 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 5 Mar 2021 (estimated)
- First posted
- 5 Jan 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 study was designed to evaluate the efficacy of Remdesivir and Baricitinib combination therapy for the treatment of severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to compare the outcome of the "Remdesivir + Baricitinib" combination against "Remdesivir + Tocilizumab" therapy and find the best option for the management of ARDS in COVID-19 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Remdesivir + Baricitinib treatment group | Experimental | Drug: Remdesivir, Drug: BaricitinibRemdesivir (Injectable solution): A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization. + Baricitinib (oral tablet form): Baricitinib tablets 4 mg/day for 2 to 4weeks |
| Group B: Remdesivir + Tocilizumab treatment group | Active comparator | Drug: Remdesivir, Drug: TocilizumabRemdesivir (Injectable solution) A loading dose of Remdesivir I/V 5mg/kg (less than 40kg) or 200mg (>40kg) on day 1, then 2.5mg/kg (less than 40kg) or 100mg (>40kg) daily following randomization. + Tocilizumab (Injectable solution): Tocilizumab I/V 8mg/Kg up to 800mg highest 12 hours apart. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.
Key exclusion criteria (1 listed)
- Participants with uncontrolled clinical status who were hospitalized from the before. Contraindication / possible drug interaction. Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/ renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.
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 |
|---|---|---|
| RemdesivirAlso: NinavirRemdesivir 100 IV Infusion as a lyophilized powder | Drug | Group A: Remdesivir + Baricitinib treatment group, Group B: Remdesivir + Tocilizumab treatment group |
| BaricitinibBaricitinib oral tablet form | Drug | Group A: Remdesivir + Baricitinib treatment group |
| TocilizumabTocilizumab IV Infusion | Drug | Group B: Remdesivir + Tocilizumab treatment group |
Primary outcome
Time to Clinical Improvement (TTCI)
Time frame: Following randomization 30 days
Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours.
5 secondary outcomes
Mortality Rate
Time frame: Following randomization 30 days.
Duration of ICU stay
Time frame: Following randomization 30 days.
Duration total hospital stay
Time frame: Following randomization 30 days.
Rate of daily Supplemental Oxygen Use
Time frame: Following randomization 30 days.
Time to Clinical Failure
Time frame: Following randomization 30 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD study chair
First Affiliated Hospital Xi'an Jiaotong University
Akter Kamal, MD, PhD study director
M Abdur Rahim Medical College and Hospital
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 Remdesivir, Baricitinib and Tocilizumab in people with Covid19 and Covid-19 ARDS, run by M Abdur Rahim Medical College and Hospital 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 5 Jan 2021. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD (008801817711079, dr_mohiuddinchy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Improvement (TTCI) (time frame: Following randomization 30 days). 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 Jan 2021.