Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19)
Status:
Completed
Trial end date:
2021-04-30
Target enrollment:
Participant gender:
Summary
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.