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Completed

NCT Number: NCT04678739

Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial

This randomized clinical trial was designed and intended to evaluate the efficacy of Remdesivir and Tocilizumab as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by Coronavirus disease 2019 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.

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Key information

Conditions

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

Age range

16 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chattogram General Hospital, Chittagong, Bangladesh

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Exclusion criteria

  • Participants with uncontrolled clinical status who were hospitalized from the before.
  • Contraindication / possible drug interaction.
  • Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, AIDS, Pulmonary TB, pregnancy, Corpulmonale, and etc.

Treatment and study plan

Remdesivir

Drug

Remdesivir 100 IV Infusion as a lyophilized powder

Tocilizumab

Drug

Actemra IV Infusion

Other names: Actemra IV Infusion

Primary outcomes

  1. Time to Clinical Improvement (TTCI)

    Time frame: Following randomization 30 days.

    Time to Clinical Improvement (TTCI) Defined as Time from Randomization to National Early Warning Score 2 (NEWS2) Score of </= 2 Maintained for 24 Hours.

Secondary outcomes

  1. Duration of ICU Stay

    Time frame: Following randomization 30 days.

    Duration of ICU Stay in Days

  2. Mortality Rate

    Time frame: Following randomization 30 days.

    Mortality Rate on Days during hospitalization

  3. Time to Recovery

    Time frame: Following randomization 30 days.

    Defined as Time from Randomization to the Time when a Non-ICU Hospital Ward or not Requiring Supplemental Oxygen, or Better is Observed

  4. Hospital stay

    Time frame: Following randomization 30 days.

    Time from Randomization to Hospital Discharge or "Ready for Discharge" (as Evidenced by Normal Body Temperature and Respiratory Rate, and Stable Oxygen Saturation on Ambient Air or </= 4L Supplemental Oxygen)

  5. Rate of daily Supplemental Oxygen Use

    Time frame: Following randomization 30 days.

    Rate of daily Supplemental Oxygen Use by the patient

  6. Time to Clinical Failure

    Time frame: Following randomization 30 days.

    Time to Clinical Failure, Defined as the Time from Randomization to the First Occurrence of Death, Mechanical Ventilation or Withdrawal (whichever occurs first)

Sponsors and collaborators

Lead sponsor

M Abdur Rahim Medical College and Hospital

Other Gov

Collaborators

  • Chattogram General Hospital
  • Cox's Bazar 250 Bed District Sadar Hospital
  • First Affiliated Hospital Xi'an Jiaotong University

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2020
Registry last updated
Apr 2, 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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