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

March 31, 2021 updated by: Abu Taiub Mohammed Mohiuddin Chowdhury, M Abdur Rahim Medical College and Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

205

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Chittagong, Bangladesh, 4000
        • Chattogram General Hospital
      • Cox's Bazar, Bangladesh
        • Cox's Bazar 250 Bed District Sadar Hospital
      • Dinajpur, Bangladesh, 5200
        • M. Abdur Rahim Medical College Hospital
      • Dinajpur, Bangladesh
        • M. Abdur Rahim Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Following randomization 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of ICU Stay
Time Frame: Following randomization 30 days.
Duration of ICU Stay in Days
Following randomization 30 days.
Mortality Rate
Time Frame: Following randomization 30 days.
Mortality Rate on Days during hospitalization
Following randomization 30 days.
Time to Recovery
Time Frame: 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
Following randomization 30 days.
Hospital stay
Time Frame: 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)
Following randomization 30 days.
Rate of daily Supplemental Oxygen Use
Time Frame: Following randomization 30 days.
Rate of daily Supplemental Oxygen Use by the patient
Following randomization 30 days.
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 or Withdrawal (whichever occurs first)
Following randomization 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M Abdur Rahim Medical College and Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2020

Primary Completion (Actual)

January 30, 2021

Study Completion (Actual)

February 10, 2021

Study Registration Dates

First Submitted

December 19, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (Actual)

December 22, 2020

Study Record Updates

Last Update Posted (Actual)

April 2, 2021

Last Update Submitted That Met QC Criteria

March 31, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M.A.R.M.C.D./2020/1985

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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