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

NCT04678739 | Completed Phase 3 DMC

• 1 other identifier: M.A.R.M.C.D./2020/1985
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 4

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.

Conditions

Covid19; Covid-19 ARDS

Keywords

COVID 19; Remdesivir; Ticilizumab; COVID-19 ARDS

Outcome Measures

Primary Outcomes (1)

• 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.

  Following randomization 30 days.

Secondary Outcomes (6)

• Duration of ICU Stay

  Following randomization 30 days.

• Mortality Rate

  Following randomization 30 days.

• Time to Recovery

  Following randomization 30 days.

• Hospital stay

  Following randomization 30 days.

• Rate of daily Supplemental Oxygen Use

  Following randomization 30 days.

Study Arms (2)

Group A: Remdesivir + Tocilizumab treatment group

EXPERIMENTAL

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; Drug: Tocilizumab

Group B: Control group

NO INTERVENTION

Treatment as given without Remdesivir and Tocilizumab.

Interventions

Remdesivir DRUG

Remdesivir 100 IV Infusion as a lyophilized powder

Group A: Remdesivir + Tocilizumab treatment group

Tocilizumab DRUG

Actemra IV Infusion

Also known as: Actemra IV Infusion

Group A: Remdesivir + Tocilizumab treatment group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (4)

Chattogram General Hospital

Chittagong, 4000, Bangladesh

Location

Cox's Bazar 250 Bed District Sadar Hospital

Cox’s Bāzār, Bangladesh

Location

M. Abdur Rahim Medical College Hospital

Dinajpur, 5200, Bangladesh

Location

M. Abdur Rahim Medical College Hospital

Dinajpur, Bangladesh

Location

Related Publications (1)

• 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.

  PMID: 35450050 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

remdesivir; tocilizumab

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

• Akter Kamal, MD, PhD

  M Abdur Rahim Medical College Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: December 19, 2020
• First Posted: December 22, 2020
• Study Start: August 15, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 10, 2021
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BA (4)