An International Randomized Trial of Additional Treatments for COVID-19 in Hospitalized Patients Who Are All Receiving the Local Standard of Care

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-29

Study Completion Date

2022-11-30

Brief Summary

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This study is an adaptive, randomized, open-label, controlled clinical trial, performed worldwide in collaboration with WHO and INSERM.

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Detailed Description

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Conditions

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SARS-CoV-2 Infection COVID-19 Moderate and Severe COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Standard of Care (SoC)

This arm will receive standard supportive care according to guidelines for COVID-19. This is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Group Type OTHER

Standard of Care (SoC)

Intervention Type OTHER

Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Remdesivir + SoC

Remdesivir 200 mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care

Group Type EXPERIMENTAL

Standard of Care (SoC)

Intervention Type OTHER

Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Remdesivir

Intervention Type DRUG

Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first

Interventions

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Standard of Care (SoC)

Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.

Intervention Type OTHER

Remdesivir

Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients 18 years and older
* Current SARS-CoV-2 infection
* Admitted to the hospital ward or the ICU due to COVID-19
* SpO2 \<= 94% on room air OR oxygen demand OR breathing support
* Written informed consent obtained

Exclusion Criteria

* Patient's non-consent or inability to informed consent
* Pregnant or breastfeeding women.
* Subjects pretreated with one of the study drugs in the past 29 days
* Anticipated transfer within 72 hours to a non-study hospital
* Severe co-morbidity with life expectancy \< 3 months
* AST or ALT \> 5 times the upper limit of normal
* Stage 4 severe chronic kidney disease or requiring dialysis
* Contraindications and known intolerance to any of the study drugs
* Subjects participating in a potentially confounding drug or device trial
* Any reason why the patient should not participate (investigator's opinion)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No