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Efficacy of Ramdicivir and Baricitinib for the Treatment of Severe COVID 19 Patients

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ClinicalTrials.gov Identifier: NCT04693026
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborator:
First affiliated Hospital Xi'an Jiaoting University
Information provided by (Responsible Party):
Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University

Brief 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). 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.

Condition or disease Intervention/treatment Phase
Covid19 Covid-19 ARDS Drug: Remdesivir Drug: Baricitinib Drug: Tocilizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of Ramdicivir and Baricitinib Combination Therapy for the Treatment of COVID 19 ARDS
Actual Study Start Date : September 10, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : March 5, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group A: Remdesivir + Baricitinib treatment group

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

Drug: Remdesivir
Remdesivir 100 IV Infusion as a lyophilized powder
Other Name: Ninavir

Drug: Baricitinib
Baricitinib oral tablet form

Active Comparator: Group B: Remdesivir + Tocilizumab treatment group

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.

Drug: Remdesivir
Remdesivir 100 IV Infusion as a lyophilized powder
Other Name: Ninavir

Drug: Tocilizumab
Tocilizumab IV Infusion




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Mortality Rate [ Time Frame: Following randomization 30 days. ]
    Mortality Rate on Days during hospitalization

  2. Duration of ICU stay [ Time Frame: Following randomization 30 days. ]
    Duration of ICU Stay in days.

  3. Duration total hospital stay [ Time Frame: Following randomization 30 days. ]
    Duration of hospital stay in days.

  4. Rate of daily Supplemental Oxygen Use [ Time Frame: Following randomization 30 days. ]
    Rate of daily Supplemental Oxygen Use by the patient

  5. Time to Clinical Failure [ Time Frame: Following randomization 30 days. ]
    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)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Severe COVID-19 patients require hospitalization under HDU/ICU. The SARSCoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Exclusion Criteria:

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693026


Contacts
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Contact: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD 008801817711079 dr_mohiuddinchy@yahoo.com
Contact: Akter Kamal, MD, PhD 008801817233991 kamalaktar@yahoo.com

Locations
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Bangladesh
M. Abdur Rahim Medical College Hospital Recruiting
Dinajpur, Bangladesh, 5200
Contact: Akter Kamal, MD, PhD    0088017233991    kamalaktar@yahoo.com   
Contact: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD    008801817711079    dr_mohiuddinchy@yahoo.com   
Sponsors and Collaborators
M Abdur Rahim Medical College and Hospital
First affiliated Hospital Xi'an Jiaoting University
Investigators
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Study Chair: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD First Affiliated Hospital Xi'an Jiaotong University
Study Director: Akter Kamal, MD, PhD M Abdur Rahim Medical College and Hospital
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Responsible Party: Abu Taiub Mohammed Mohiuddin Chowdhury, Resident, First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT04693026    
Other Study ID Numbers: M.A.R.M.C.D./2020/2637
First Posted: January 5, 2021    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Abu Taiub Mohammed Mohiuddin Chowdhury, First Affiliated Hospital Xi'an Jiaotong University:
COVID 19
Covid-19 ARDS
Tocilizumab
Remdicivir
Baricitinib
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Remdesivir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents