A Trial of Remdesivir in Adults With Mild and Moderate COVID-19

• Status: Suspended
• Trial end date: 2020-04-27
• 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 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 mild or moderate COVID-19.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Capital Medical University
• Collaborator: Chinese Academy of Medical Sciences
• 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. Hospitalised with:

• Fever - ≥36.7℃ -axilla or Oral temperature ≥ 38.0 ℃ or ≥38.6°C tympanic or rectal or

• And at least one of Respiratory rate >24/min Or Cough

5. ≤8 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. SaO2/SPO2≤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg

4. Known allergic reaction to remdesivir

5. 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

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

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

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