NCT04596839

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

Completed Phase 2 Last updated 10 August 2021

What this trial tests

Phase 2 trial testing Remdesivir in Covid19 in 60 participants. Completed in 30 April 2021.

Timeline

4 September 2020

Primary endpoint
30 April 2021

30 April 2021

Quick facts

Lead sponsor	Dr. Md. Alimur Reza
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	4 September 2020
Primary completion	30 April 2021
Estimated completion	30 April 2021
Sites	1 location across Bangladesh

Drugs / interventions tested

• Remdesivir (remdesivir) — full drug profile →
• Standard of Care

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Dr. Md. Alimur Reza

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Remdesivir for the treatment of COVID-19.
   Ansems K, Grundeis F, Dahms K, Mikolajewska A, et al · · 2021 · cited 89× · PMID 34350582 · DOI 10.1002/14651858.cd014962
2. Remdesivir for treatment of COVID-19; an updated systematic review and meta-analysis.
   Rezagholizadeh A, Khiali S, Sarbakhsh P, Entezari-Maleki T. · · 2021 · cited 85× · PMID 33549577 · DOI 10.1016/j.ejphar.2021.173926
3. Remdesivir for the treatment of COVID-19.
   Grundeis F, Ansems K, Dahms K, Thieme V, et al · · 2023 · cited 55× · PMID 36695483 · DOI 10.1002/14651858.cd014962.pub2
4. Baricitinib combination therapy: a narrative review of repurposed Janus kinase inhibitor against severe SARS-CoV-2 infection.
   Akbarzadeh-Khiavi M, Torabi M, Rahbarnia L, Safary A. · · 2022 · cited 21× · PMID 34902115 · DOI 10.1007/s15010-021-01730-6
5. The IDentif.AI-x pandemic readiness platform: Rapid prioritization of optimized COVID-19 combination therapy regimens.
   Blasiak A, Truong ATL, Remus A, Hooi L, et al · · 2022 · cited 17× · PMID 35773329 · DOI 10.1038/s41746-022-00627-4
6. Potential treatments of COVID-19: Drug repurposing and therapeutic interventions.
   Raghav PK, Mann Z, Ahluwalia SK, Rajalingam R. · · 2023 · cited 11× · PMID 37059487 · DOI 10.1016/j.jphs.2023.02.004
7. Potential Anti-SARS-CoV-2 Prodrugs Activated by Phosphorylation and Their Role in the Aged Population.
   Chavda VP, Teli D, Balar PC, Vaghela D, et al · · 2023 · cited 3× · PMID 36903575 · DOI 10.3390/molecules28052332
8. The IDentif.AI 2.0 Pandemic Readiness Platform: Rapid Prioritization of Optimized COVID-19 Combination Therapy Regimens
   Blasiak A, Truong AT, Remus A, Hooi L, et al · · 2021 · DOI 10.1101/2021.06.23.21259321