search
Back to results

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

Primary Purpose

Covid19, Covid-19 ARDS

Status
Completed
Phase
Phase 3
Locations
Bangladesh
Study Type
Interventional
Intervention
Remdesivir
Tocilizumab
Sponsored by
M Abdur Rahim Medical College and Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID 19, Remdesivir, Ticilizumab, COVID-19 ARDS

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chattogram General Hospital
  • Cox's Bazar 250 Bed District Sadar Hospital
  • M. Abdur Rahim Medical College Hospital
  • M. Abdur Rahim Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Group A: Remdesivir + Tocilizumab treatment group

Group B: Control group

Arm Description

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.

Treatment as given without Remdesivir and Tocilizumab.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of ICU Stay
Duration of ICU Stay in Days
Mortality Rate
Mortality Rate on Days during hospitalization
Time to Recovery
Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed
Hospital stay
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)
Rate of daily Supplemental Oxygen Use
Rate of daily Supplemental Oxygen Use by the patient
Time to Clinical Failure
Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation or Withdrawal (whichever occurs first)

Full Information

First Posted
December 19, 2020
Last Updated
March 31, 2021
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
search

1. Study Identification

Unique Protocol Identification Number
NCT04678739
Brief Title
Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
Official Title
Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2020 (Actual)
Primary Completion Date
January 30, 2021 (Actual)
Study Completion Date
February 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the 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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Covid-19 ARDS
Keywords
COVID 19, Remdesivir, Ticilizumab, COVID-19 ARDS

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A: Remdesivir + Tocilizumab treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
Group B: Control group
Arm Type
No Intervention
Arm Description
Treatment as given without Remdesivir and Tocilizumab.
Intervention Type
Drug
Intervention Name(s)
Remdesivir
Intervention Description
Remdesivir 100 IV Infusion as a lyophilized powder
Intervention Type
Drug
Intervention Name(s)
Tocilizumab
Other Intervention Name(s)
Actemra IV Infusion
Intervention Description
Actemra IV Infusion
Primary Outcome Measure Information:
Title
Time to Clinical Improvement (TTCI)
Description
Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours.
Time Frame
Following randomization 30 days.
Secondary Outcome Measure Information:
Title
Duration of ICU Stay
Description
Duration of ICU Stay in Days
Time Frame
Following randomization 30 days.
Title
Mortality Rate
Description
Mortality Rate on Days during hospitalization
Time Frame
Following randomization 30 days.
Title
Time to Recovery
Description
Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed
Time Frame
Following randomization 30 days.
Title
Hospital stay
Description
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)
Time Frame
Following randomization 30 days.
Title
Rate of daily Supplemental Oxygen Use
Description
Rate of daily Supplemental Oxygen Use by the patient
Time Frame
Following randomization 30 days.
Title
Time to Clinical Failure
Description
Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation or Withdrawal (whichever occurs first)
Time Frame
Following randomization 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Akter Kamal, MD, PhD
Organizational Affiliation
M Abdur Rahim Medical College Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Chattogram General Hospital
City
Chittagong
ZIP/Postal Code
4000
Country
Bangladesh
Facility Name
Cox's Bazar 250 Bed District Sadar Hospital
City
Cox's Bazar
Country
Bangladesh
Facility Name
M. Abdur Rahim Medical College Hospital
City
Dinajpur
ZIP/Postal Code
5200
Country
Bangladesh
Facility Name
M. Abdur Rahim Medical College Hospital
City
Dinajpur
Country
Bangladesh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35450050
Citation
Mohiuddin Chowdhury ATM, Kamal A, Abbas KU, Talukder S, Karim MR, Ali MA, Nuruzzaman M, Li Y, He S. Efficacy and Outcome of Remdesivir and Tocilizumab Combination Against Dexamethasone for the Treatment of Severe COVID-19: A Randomized Controlled Trial. Front Pharmacol. 2022 Apr 5;13:690726. doi: 10.3389/fphar.2022.690726. eCollection 2022.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs