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NCT Number: NCT04596839

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

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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Combined Military Hospital

Dhaka, 1206, Bangladesh

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years at time of signing Informed Consent Form
  • 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
  • Willingness of study participant to accept randomization to any assigned treatment arm
  • 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.

Treatment and study plan

Remdesivir

Drug

Remdesivir INN 100 mg lyophilized powder for infusion

Standard of care

Other

Standard of Care Treatment for COVID-19 Infection

Primary outcomes

  1. Duration of hospital stay (Days)

    Time frame: 28 Days

Secondary outcomes

  1. 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;
    • Death;

  2. All causes mortality

    Time frame: 28 Days

  3. Duration (days) of mechanical ventilation

    Time frame: 28 Days

  4. Duration (days) of supplemental oxygenation

    Time frame: 28 Days

  5. Time to 2019-nCoV RT-PCR negativity in Nasopharyngeal Swab

    Time frame: 28 Days

  6. Frequency of serious adverse drug events

    Time frame: 28 Days

Sponsors and collaborators

Lead sponsor

Dr. Md. Alimur Reza

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 22, 2020
Registry last updated
Aug 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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