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

Sponsor
M Abdur Rahim Medical College and Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04693026
Collaborator
First affiliated Hospital Xi'an Jiaoting University (Other)
150
1
2
5.8
25.9

Study Details

Study Description

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
Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Sep 10, 2020
Anticipated Primary Completion Date :
Feb 15, 2021
Anticipated Study Completion Date :
Mar 5, 2021

Arms and Interventions

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 Names:
  • 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 Names:
  • Ninavir
  • Drug: Tocilizumab
    Tocilizumab IV Infusion

    Outcome Measures

    Primary Outcome Measures

    1. Time to Clinical Improvement (TTCI) [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 [Following randomization 30 days.]

      Mortality Rate on Days during hospitalization

    2. Duration of ICU stay [Following randomization 30 days.]

      Duration of ICU Stay in days.

    3. Duration total hospital stay [Following randomization 30 days.]

      Duration of hospital stay in days.

    4. Rate of daily Supplemental Oxygen Use [Following randomization 30 days.]

      Rate of daily Supplemental Oxygen Use by the patient

    5. Time to Clinical Failure [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M. Abdur Rahim Medical College Hospital Dinajpur Bangladesh 5200

    Sponsors and Collaborators

    • M Abdur Rahim Medical College and Hospital
    • First affiliated Hospital Xi'an Jiaoting University

    Investigators

    • 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    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:
    Jan 5, 2021
    Last Update Posted:
    Jan 5, 2021
    Last Verified:
    Dec 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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, Resident, First Affiliated Hospital Xi'an Jiaotong University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 5, 2021