Last Verified: | March/31/2020 |
First Submitted: | January/30/2020 |
Estimated Enrollment Submitted: | January/30/2020 |
First Posted: | February/4/2020 |
Last Update Submitted: | April/12/2020 |
Last Update Posted: | April/14/2020 |
Actual Study Start Date: | February/11/2020 |
Estimated Primary Completion Date: | April/9/2020 |
Estimated Study Completion Date: | April/26/2020 |
Study Type: | Interventional |
Allocation: | Randomized |
Primary Purpose: | Treatment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Arm | Intervention/treatment |
---|---|
Experimental: Remdesivir group active remdesivir | Drug: Remdesivir group RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days. |
Placebo Comparator: Control group Placebos matched remdesivir | Drug: Control group RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days. |
Ages Eligible for Study: | 18 Years to 18 Years |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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. |