Clinical trial NCT05620160: Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19
Official title: A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of RAY1216 Tablets in Patients With Mild to Moderate SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild to Moderate COVID-19
Lead sponsor: Guangdong Raynovent Biotech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 1359
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Participants who provide written informed consent before the trial, and fully understand the trial content, process and possible adverse reactions.
2. Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures.
3. Male or female participants aged 18-75 (including 18 and 75 years old).
4. Confirmed SARS-CoV-2 infection 120 hours prior to randomization.
5. Initial onset of COVID-19 symptoms/signs within 48 hours before randomization.
6. Fertile participants must agree to take effective contraceptive measures.

Exclusion Criteria:

1. 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.
2. Difficulty swallowing or a history of gastrointestinal diseases that seriously affect drug absorption.
3. Active liver disease, or obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥ 2ULN).
4. WBC \>1ULN, or NEU \<0.5ⅹ109/L.
5. Receiving dialysis or have known moderate to severe renal impairment (eGFR\<60mL/min/1.73m2).
6. Other suspected or confirmed systemic infections.
7. Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 or CYP2C19 for clearance.
8. Prior or anticipated receipt of any vaccine within 28 days prior to enrollment and during study period.
9. Use of antivirals against SARS-CoV-2 within 7 days prior to enrollment.
10. Weight≤40kg.
11. Pregnant, lactating women or those with a positive pregnancy test (sterilized or postmenopausal women may not have a pregnancy test).
12. Previous administration with any investigational drug within 3 months before the study drug administration.
13. Participants who are judged by the investigator to be unsuitable to participate in this study.

Primary outcomes:
measure: Time to sustained clinical recovery of 11 COVID-19 symptoms
timeFrame: Day 1 through Day 29
Secondary outcomes:
measure: Proportion of participants who experience hospitalization or death cause by progression to severe disease
timeFrame: Day 1 through Day 29
measure: Proportion of participants who experience death from any cause
timeFrame: Day 1 through Day 29
measure: Proportion of participants who experience COVID-19 related hospitalization or death from any cause
timeFrame: Day 1 through Day 29
measure: SARS-CoV-2 viral shedding time in nasopharyngeal swabs
timeFrame: baseline, Day 4, Day 6, Day 10, Day 15
measure: Change of viral load compared to the baseline
timeFrame: baseline, Day 4, Day 6, Day 10, Day 15
measure: Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
timeFrame: baseline, Day 4, Day 6, Day 10, Day 15
measure: Time to clinical sustained remission
timeFrame: Day 1 through Day 29
measure: Proportion of participants in clinical recovery/remission
timeFrame: Day 1 through Day 29
measure: Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
timeFrame: Day 1 through Day 29
measure: Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
timeFrame: Day 1 through Day 29
measure: Time to sustained clinical recovery of each COVID-19 targeted symptoms
timeFrame: Day 1 through Day 29
measure: Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Day 1 through Day 29
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital Of Guangzhou Medical University
state: Guangdong
Study officials:
References: