Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19)

August 9, 2021 updated by: Dr. Md. Alimur Reza

Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19): An Open Label, Multi-Center, Randomized Controlled Trial

Background - A novel coronavirus, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in December 2019 as the cause of a respiratory illness COVID-19 in Wuhan City, China. WHO declared a public health emergency outbreak of this virus on 30 January 2020 and declared COVID-19 a global pandemic on 11 March, 2020. Bangladesh reported its first case on March 8, 2020 and first fatality on April 1, 2020. Bangladesh had shown a staggered course of COVID-19 transmission initially but a surge in cases was observed from April, 2020.

Remdesivir remains as the only potential therapy for the treatment of COVID-19 till date. Based on several pre-clinical studies in SARS-CoV and MERS-CoV infections, Animal trials in COVID-19 and data from human trials, this randomized, controlled, open label trial will evaluate the antiviral activity and safety of Remdesivir in Bangladeshi hospitalized patients with severe COVID-19.

This study finding will provide knowledge if Remdesivir is effective enough to treat Bangladeshi COVID-19 hospitalized patients with adequate safety and tolerability. The result of this study will help the key opinion leaders regarding the matter, to take appropriate decision regarding usage of Remdesivir for the treatment of COVID-19 in Bangladesh.

Study Procedure - All patients will receive the standard medical care for COVID-19+ve at the respective hospitals. Vital signs will be recorded every 24 hrs for 1st 5 days then once in 2 days till discharge or as per the discretion of the attending physicians. After screening the COVID-19 confirmed patients will be randomized into 2 treatment arms.

Patient's safety assessment e. g. blood parameters (CBC, Creatinine, SGPT, RBS, Creatinine, Creatinine Clearance) will be done on screening, day 5 and day 14 or discharge; Chest X-ray and ECG on screening and day 14 or discharge. SARS-CoV-2 (viral load) will be looked in on day 5, day 10 and day 14 or at the time of discharge. In case any study patient deteriorates during the study period will be managed as per the guideline of that particular hospital and if needed will be shifted to ICU. Patients who will recover will be discharged as per the national guideline for the COVID-19 hospitalized patients. Patients will be contacted at 28 days either over phone or in person to get their health status since discharge.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

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
      • Dhaka, Bangladesh, 1206
        • Combined Military 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age ≥18 years at time of signing Informed Consent Form

  2. Hospitalized with diagnosed COVID-19 confirmed by RT-PCR test ≤ 7 days before randomization with any one following criteria

    • Respiratory distress (≥30 breaths/min);
    • Finger oxygen saturation ≤93% at rest;
    • Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤300mmHg
  3. Willingness of study participant to accept randomization to any assigned treatment arm
  4. Must agree not to enroll in another study of an investigational agent prior to completion of Day 28 of study

Exclusion Criteria:

  • Physician makes a decision that trial involvement is not in patients' best interest, or any condition that does not allow the protocol to be followed safely.
  • Severe liver disease (Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit of normal)
  • Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration).
  • Mechanically ventilated (including V-V ECMO) ≥ 5 days, or any duration of V-A ECMO.
  • Known hypersensitivity to the Remdesivir, the metabolites, or formulation excipient
  • Pregnancy or breast feeding.
  • Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.

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: Remdesivir with Standard of Care Treatment for COVID-19 Infection
Participants will receive continued standard of care therapy together with RDV 200 mg on Day 1 followed by RDV 100 mg on Days 2, 3, 4, and 5.
Drug: Remdesivir
Remdesivir INN 100 mg lyophilized powder for infusion
Other: Standard of Care Treatment for COVID-19 Infection
Participants will receive continued standard of care therapy.
Other: Standard of Care
Standard of Care Treatment for COVID-19 Infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of hospital stay (Days)
Time Frame: 28 Days
28 Days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinical Improvement (TTCI)
Time Frame: 28 Days

Time to clinical improvement (censored at Day 28), defined as the time (in days) from randomization of study treatment until a decline of two categories on a six-category ordinal scale of clinical status (1 ꞊ discharged; 6 ꞊ death) or live discharge from hospital.

Six-category ordinal scale:

  1. Hospital discharge or meet discharge criteria
  2. Hospitalization, not requiring supplemental oxygen;
  3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);
  4. ICU/hospitalization, requiring NIV/ HFNC therapy;
  5. ICU, requiring ECMO and/or IMV;
  6. Death;
28 Days
All causes mortality
Time Frame: 28 Days
28 Days
Duration (days) of mechanical ventilation
Time Frame: 28 Days
28 Days
Duration (days) of supplemental oxygenation
Time Frame: 28 Days
28 Days
Time to 2019-nCoV RT-PCR negativity in Nasopharyngeal Swab
Time Frame: 28 Days
28 Days
Frequency of serious adverse drug events
Time Frame: 28 Days
28 Days

Collaborators and Investigators

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

Sponsor

Dr. Md. Alimur Reza

Investigators

  • Principal Investigator: Major General Md. Azizul Islam, MBBS, FCPS, Combined Military 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

Helpful Links

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)

September 4, 2020

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

October 20, 2020

First Submitted That Met QC Criteria

October 20, 2020

First Posted (Actual)

October 22, 2020

Study Record Updates

Last Update Posted (Actual)

August 10, 2021

Last Update Submitted That Met QC Criteria

August 9, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEX-06001

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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