Clinical trial NCT04596839: Antiviral Activity and Safety of Remdesivir in Bangladeshi Patients With Severe Coronavirus Disease (COVID-19)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Covid19
Keywords: Remdesivir
Lead sponsor: Beximco Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2020-10-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Duration of hospital stay (Days)
timeFrame: 28 Days
Secondary outcomes:
measure: Time to Clinical Improvement (TTCI)
timeFrame: 28 Days
measure: All causes mortality
timeFrame: 28 Days
measure: Duration (days) of mechanical ventilation
timeFrame: 28 Days
measure: Duration (days) of supplemental oxygenation
timeFrame: 28 Days
measure: Time to 2019-nCoV RT-PCR negativity in Nasopharyngeal Swab
timeFrame: 28 Days
measure: Frequency of serious adverse drug events
timeFrame: 28 Days
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: Combined Military Hospital
Study officials:
affiliation: Combined Military Hospital
name: Major General Md. Azizul Islam, MBBS, FCPS
role: PRINCIPAL_INVESTIGATOR
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