Overview

A Trial of Remdesivir in Adults With Severe COVID-19

Status:
Terminated
Trial end date:
2020-04-10
Target enrollment:
0
Participant gender:
All
Summary
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (SARS-CoV-2) from these pneumonia patients and developed a real-time reverse transcription PCR (real-time RT-PCR) diagnostic assay. Given no specific antiviral therapy for COVID-19 and the ready availability of remdesvir as a potential antiviral agent, based on pre-clinical studies in SARS-CoV and MERS-CoV infections, this randomized, controlled, double blind trial will evaluate the efficacy and safety of remdesivir in patients hospitalized with severe COVID-19.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Capital Medical University
Treatments:
Remdesivir
Criteria
Inclusion Criteria:

1. Age ≥18 years at time of signing Informed Consent Form

2. Laboratory (RT-PCR) confirmed COVID-19.

3. Lung involvement confirmed with chest imaging

4. Hospitalized with a SaO2/SPO2≤94% on room air or Pa02/Fi02 ratio <300mgHg

5. ≤12 days since illness onset

6. Willingness of study participant to accept randomization to any assigned treatment
arm.

7. Must agree not to enroll in another study of an investigational agent prior to
completion of Day 28 of study.

Exclusion Criteria:

1. 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.

2. Severe liver disease (e.g. Child Pugh score ≥ C, AST>5 times upper limit)

3. Pregnant or breastfeeding, or positive pregnancy test in a predose examination

4. Patients with known severe renal impairment (estimated glomerular filtration rate ≤30
mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis,
peritoneal dialysis

5. Will be transferred to another hospital which is not the study site within 72 hours.

6. Receipt of any experimental treatment for COVID-19 within the 30 days prior to the
time of the screening evaluation.