NCT05620160CompletedPhase 3
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of RAY1216 Tablets in Patients With Mild to Moderate SARS-CoV-2 Infection
Guangdong Raynovent Biotech Co., Ltd1 site in 1 country1,359 target enrollmentStarted: November 12, 2022Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 1,359
- Locations
- 1
- Primary Endpoint
- Time to sustained clinical recovery of 11 COVID-19 symptoms
Study Overview
Brief Summary
This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of RAY1216 tablets in the treatment of mild to moderate SARS-CoV-2 infection. The total study duration is up to 28 days.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants who provide written informed consent before the trial, and fully understand the trial content, process and possible adverse reactions.
- •Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures.
- •Male or female participants aged 18-75 (including 18 and 75 years old).
- •Confirmed SARS-CoV-2 infection 120 hours prior to randomization.
- •Initial onset of COVID-19 symptoms/signs within 48 hours before randomization.
- •Fertile participants must agree to take effective contraceptive measures.
Exclusion Criteria
- •Patients with severe or critical COVID-19 who currently require hospitalization, or patients who are expected to develop into severe or critical disease and require hospitalization within 48h after randomization.
- •Difficulty swallowing or a history of gastrointestinal diseases that seriously affect drug absorption.
- •Active liver disease, or obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥ 2ULN).
- •WBC >1ULN, or NEU <0.5ⅹ109/L.
- •Receiving dialysis or have known moderate to severe renal impairment (eGFR<60mL/min/1.73m2).
- •Other suspected or confirmed systemic infections.
- •Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 or CYP2C19 for clearance.
- •Prior or anticipated receipt of any vaccine within 28 days prior to enrollment and during study period.
- •Use of antivirals against SARS-CoV-2 within 7 days prior to enrollment.
- •Weight≤40kg.
- •Pregnant, lactating women or those with a positive pregnancy test (sterilized or postmenopausal women may not have a pregnancy test).
- •Previous administration with any investigational drug within 3 months before the study drug administration.
- •Participants who are judged by the investigator to be unsuitable to participate in this study.
Arms & Interventions
RAY1216
Experimental
Participants received 400mg RAY1216 tablet orally three times daily for 5 days.
Intervention: RAY1216 (Drug)
Placebo
Placebo Comparator
Participants received 400mg placebo orally three times daily for 5 days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Time to sustained clinical recovery of 11 COVID-19 symptoms
Time Frame: Day 1 through Day 29
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days.
Secondary Outcomes
- Proportion of participants who experience hospitalization or death cause by progression to severe disease(Day 1 through Day 29)
- Proportion of participants who experience COVID-19 related hospitalization or death from any cause(Day 1 through Day 29)
- SARS-CoV-2 viral shedding time in nasopharyngeal swabs(baseline, Day 4, Day 6, Day 10, Day 15)
- Proportion of participants who are negative for SARS-CoV-2 nucleic acid test(baseline, Day 4, Day 6, Day 10, Day 15)
- Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)(Day 1 through Day 29)
- Proportion of participants in clinical recovery/remission(Day 1 through Day 29)
- Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms(Day 1 through Day 29)
- Proportion of participants who experience death from any cause(Day 1 through Day 29)
- Time to sustained clinical recovery of each COVID-19 targeted symptoms(Day 1 through Day 29)
- Change of viral load compared to the baseline(baseline, Day 4, Day 6, Day 10, Day 15)
- Time to clinical sustained remission(Day 1 through Day 29)
- Time to sustained clinical recovery of 10 COVID-19 symptoms except cough(Day 1 through Day 29)
Investigators
Study Sites (1)
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