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Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

Sponsor
M Abdur Rahim Medical College and Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04678739
Collaborator
First Affiliated Hospital Xi'an Jiaotong University (Other), Cox's Bazar 250 Bed District Sadar Hospital (Other), Chattogram General Hospital (Other)
205
Enrollment
4
Locations
2
Arms
5.9
Actual Duration (Months)
51.3
Patients Per Site
8.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
205 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
Actual Study Start Date :
Aug 15, 2020
Actual Primary Completion Date :
Jan 30, 2021
Actual Study Completion Date :
Feb 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group A: Remdesivir + Tocilizumab treatment group

Drug: Remdesivir Injectable solution Tocilizumab 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 I/V 8mg/Kg up to 800mg highest 12 hours apart.

Drug: Remdesivir
Remdesivir 100 IV Infusion as a lyophilized powder

Drug: Tocilizumab
Actemra IV Infusion
Other Names:
  • Actemra IV Infusion

    		•
    No Intervention: Group B: Control group

    Treatment as given without Remdesivir and Tocilizumab.

    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. Duration of ICU Stay [Following randomization 30 days.]

      Duration of ICU Stay in Days

    2. Mortality Rate [Following randomization 30 days.]

      Mortality Rate on Days during hospitalization

    3. Time to Recovery [Following randomization 30 days.]

      Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed

    4. Hospital stay [Following randomization 30 days.]

      Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or </= 4L Supplemental Oxygen)

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

      Rate of daily Supplemental Oxygen Use by the patient

    6. 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 or Withdrawal (whichever occurs first)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-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 Chattogram General Hospital Chittagong Bangladesh 4000
    2 Cox's Bazar 250 Bed District Sadar Hospital Cox's Bazar Bangladesh
    3 M. Abdur Rahim Medical College Hospital Dinajpur Bangladesh 5200
    4 M. Abdur Rahim Medical College Hospital Dinajpur Bangladesh

    Sponsors and Collaborators

    • M Abdur Rahim Medical College and Hospital
    • First Affiliated Hospital Xi'an Jiaotong University
    • Cox's Bazar 250 Bed District Sadar Hospital
    • Chattogram General Hospital

    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 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:
    NCT04678739
    Other Study ID Numbers:
    • M.A.R.M.C.D./2020/1985
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Apr 2, 2021
    Last Verified:
    Mar 1, 2021
    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
    Keywords provided by Abu Taiub Mohammed Mohiuddin Chowdhury, Resident, First Affiliated Hospital Xi'an Jiaotong University
    COVID 19
    Remdesivir
    Ticilizumab
    COVID-19 ARDS
    Additional relevant MeSH terms:
    COVID-19
    Remdesivir

    Study Results

    No Results Posted as of Apr 2, 2021