Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19)
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|ClinicalTrials.gov Identifier: NCT04596839|
Recruitment Status : Active, not recruiting
First Posted : October 22, 2020
Last Update Posted : June 1, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Remdesivir Other: Standard of Care||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19): An Open Label, Multi-Center, Randomized Controlled Trial|
|Actual Study Start Date :||September 4, 2020|
|Actual Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||July 31, 2021|
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.
Remdesivir INN 100 mg lyophilized powder for infusion
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
- Duration of hospital stay (Days) [ Time Frame: 28 Days ]
- 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:
- Hospital discharge or meet discharge criteria
- Hospitalization, not requiring supplemental oxygen;
- Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);
- ICU/hospitalization, requiring NIV/ HFNC therapy;
- ICU, requiring ECMO and/or IMV;
- All causes mortality [ Time Frame: 28 Days ]
- Duration (days) of mechanical ventilation [ Time Frame: 28 Days ]
- Duration (days) of supplemental oxygenation [ Time Frame: 28 Days ]
- Time to 2019-nCoV RT-PCR negativity in Nasopharyngeal Swab [ Time Frame: 28 Days ]
- Frequency of serious adverse drug events [ Time Frame: 28 Days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04596839
|Combined Military Hospital|
|Dhaka, Bangladesh, 1206|
|Principal Investigator:||Major General Md. Azizul Islam, MBBS, FCPS||Combined Military Hospital|