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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT04252664
• Date of registration: 31/01/2020
• Prospective Registration: Yes
• Primary sponsor: Capital Medical University
• Public title: A Trial of Remdesivir in Adults With Mild and Moderate COVID-19
• Scientific title: A Phase 3 Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Remdesivir in Hospitalized Adult Patients With Mild and Moderate COVID-19.
• Date of first enrolment: February 12, 2020
• Target sample size: 308
• Recruitment status: Suspended
• URL: https://clinicaltrials.gov/show/NCT04252664
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

China

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

SARS-CoV-2

COVID-19

Intervention(s)

Drug: Remdesivir

Drug: Remdesivir placebo

Primary Outcome(s)

Time to Clinical recoveryTime to Clinical Recovery (TTCR) [Time Frame: up to 28 days]

Secondary Outcome(s)

Frequency of serious adverse events [Time Frame: up to 28 days]

Frequency of respiratory progression [Time Frame: up to 28 days]

Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve. [Time Frame: up to 28 days]

Time to dyspnea reported as mild or absent (on a scale of severe, moderate, mild absent, in those with dyspnoea at enrolment rated as severe or moderate,) [Time Frame: up to 28 days]

Frequency of requirement for mechanical ventilation [Time Frame: up to 28 days]

All cause mortality [Time Frame: up to 28 days]

Time to defervescence (in those with fever at enrolment) [Time Frame: up to 28 days]

Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen [Time Frame: up to 28 days]

Frequency of requirement for supplemental oxygen or non-invasive ventilation [Time Frame: up to 28 days]

Time to cough reported as mild or absent (in those with cough at enrolment rated severe or moderate) [Time Frame: up to 28 days]

Secondary ID(s)

CAP-China remdesivir 1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Chinese Academy of Medical Sciences