NCT04252664.

Study name	'A trial of remdesivir in adults with mild and moderate COVID‐19'
Methods	Trial design: RCT Allocation: randomised Intervention model: parallel assignment Masking: quadruple (participant, care provider, investigator, outcomes assessor) Primary purpose: treatment Sample size: NR Estimated enrolment: 308 participants Setting: inpatient Language: Chinese Number of centres: 1 (Jin Yin‐tan Hospital Wuhan, Hubei, China, 100013) Type of intervention: drug
Participants	Inclusion criteria: Age ≥ 18 years at time of signing informed consent form Laboratory (RT‐PCR)‐confirmed COVID‐19 Lung involvement confirmed with chest imaging Hospitalised with: fever ≥ 36.7 °C axilla or oral temperature ≥ 38.0 °C or ≥ 38.6 °C tympanic or rectal and at least 1 of respiratory rate > 24/min or cough ≤ 8 days since illness onset Willingness of study participant to accept randomisation to any assigned treatment arm Must agree not to enrol in another study of an investigational agent prior to completion of day 28 of study Exclusion criteria: Physician decides that trial involvement is not in patient's best interest, or any condition that does not allow the protocol to be followed safely Severe liver disease (e.g. Child‐Pugh score ≥ C, AST > 5 times upper limit) SaO2/SPO2 ≤ 94% in room air condition, or PaO2/FiO2 ratio < 300 mmHg Known allergic reaction to remdesivir Patients with known severe renal impairment (eGFR ≤ 30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, haemodialysis, peritoneal dialysis Pregnant or breastfeeding, or positive pregnancy test in a pre‐dose examination Will be transferred to another hospital which is not the study site within 72 hours Receipt of any experimental treatment for COVID‐19 within the 30 days prior to the time of the screening evaluation
Interventions	Details of intervention: Drug: remdesivir (other name: GS‐5734) Dose: RDV 200 mg loading dose (day 1), 100 mg (once daily, 9 days) maintenance doses Route of administration: intravenous Treatment details of control group: Drug: remdesivir placebo Dose: RDV placebo 200 mg loading dose (day 1), 100 mg (once daily, 9 days) maintenance dose Route of administration: intravenous Concomitant therapy: NR
Outcomes	Primary study outcome: Time to clinical recovery (TTCR) (time frame: up to 28 days) TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours, or live hospital discharge, whichever comes first. Normalisation and alleviation criteria: Fever: < 37 °C Respiratory rate: ≤ 24/min on room air Oxygen saturation: > 94% on room air Cough: mild or absent on a patient‐reported scale of severe, moderate, mild, absent Secondary outcome measures: All‐cause mortality (time frame: up to 28 days) Baseline SpO2 during screening, PaO2/FiO2 < 300 mmHg or a respiratory rate ≥ 24 breaths per minute without supplemental oxygen Frequency of respiratory progression (time frame: up to 28 days) Defined as SpO2 ≤ 94% on room air or PaO2/FiO2 < 300 mmHg and requirement for supplemental oxygen or more advanced ventilator support Time to defervescence (in those with fever at enrolment) (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) Time to dyspnoea 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 supplemental oxygen or non‐invasive ventilation (time frame: up to 28 days) Time to 2019‐nCoV RT‐PCR negative in upper respiratory tract specimen (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) Frequency of requirement for mechanical ventilation (time frame: up to 28 days) Frequency of serious adverse events (time frame: up to 28 days) Review outcomes: Inpatient setting: All‐cause mortality at day 28, day 60, time‐to‐event, and at hospital discharge: planned Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale (WHO 2020c), WHO Ordinal Scale for Clinical Improvement (WHO 2020c)) at day 28, day 60, and up to longest follow‐up), including: improvement of clinical status: planned: weaning or liberation from invasive mechanical ventilation in surviving participants, i.e. WHO ≤ 6, if ≥ 7 at baseline; ventilator‐free days; ventilator‐free defined as WHO ≤ 6; duration to liberation from invasive mechanical ventilation; liberation from supplemental oxygen in surviving participants, i.e. WHO ≤ 4, if ≥ 5 at baseline; duration to liberation from supplemental oxygen. worsening of clinical status: planned: new need for mechanical ventilation; new need for invasive mechanical ventilation; new need for non‐invasive mechanical ventilation or high‐flow oxygen; new need for oxygen by mask or nasal prongs. Need for dialysis (at up to 28 days): not planned Quality of life, including fatigue and neurological status, assessed with standardised scales (e.g. WHOQOL‐100) at up to 7 days, up to 30 days, and longest follow‐up available: not planned Admission to ICU: not planned Duration of hospitalisation: planned Time to discharge from hospital: planned Viral clearance, assessed with RT‐PCR test for SARS‐CoV‐2 at baseline and up to 3, 7, and 15 days: planned Vitamin D serum levels: not planned Serious adverse events, defined as number of participants with event: planned Adverse events (any grade, grade 1 to 2, grade 3 to 4), defined as number of participants with event: not planned
Starting date	12 February 2020
Contact information	Bin Cao, China‐Japan Friendship Hospital
Notes	Recruitment status: suspended, “The epidemic of COVID‐19 has been controlled well at present, no eligible patients can be recruited.” Prospective completion date: 10 April 2020 Date last update was posted: 15 April 2020 Sponsor/funding: Capital Medical University