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Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19

Primary Purpose

Mild to Moderate COVID-19

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
RAY1216
Placebo
Sponsored by
Guangdong Raynovent Biotech Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild to Moderate COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The First Affiliated Hospital Of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

RAY1216

Placebo

Arm Description

Participants received 400mg RAY1216 tablet orally three times daily for 5 days.

Participants received 400mg placebo orally three times daily for 5 days.

Outcomes

Primary Outcome Measures

Time to sustained clinical recovery of 11 COVID-19 symptoms
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days.

Secondary Outcome Measures

Proportion of participants who experience hospitalization or death cause by progression to severe disease
Proportion of participants who experience death from any cause
Proportion of participants who experience COVID-19 related hospitalization or death from any cause
SARS-CoV-2 viral shedding time in nasopharyngeal swabs
Change of viral load compared to the baseline
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time to clinical sustained remission
Proportion of participants in clinical recovery/remission
Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
Time to sustained clinical recovery of each COVID-19 targeted symptoms
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
November 4, 2022
Last Updated
May 22, 2023
Sponsor
Guangdong Raynovent Biotech Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05620160
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 12, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
March 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Raynovent Biotech Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild to Moderate COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1359 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RAY1216
Arm Type
Experimental
Arm Description
Participants received 400mg RAY1216 tablet orally three times daily for 5 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 400mg placebo orally three times daily for 5 days.
Intervention Type
Drug
Intervention Name(s)
RAY1216
Intervention Description
RAY1216(tablet)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo (tablet)
Primary Outcome Measure Information:
Title
Time to sustained clinical recovery of 11 COVID-19 symptoms
Description
The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 for three consecutive days.
Time Frame
Day 1 through Day 29
Secondary Outcome Measure Information:
Title
Proportion of participants who experience hospitalization or death cause by progression to severe disease
Time Frame
Day 1 through Day 29
Title
Proportion of participants who experience death from any cause
Time Frame
Day 1 through Day 29
Title
Proportion of participants who experience COVID-19 related hospitalization or death from any cause
Time Frame
Day 1 through Day 29
Title
SARS-CoV-2 viral shedding time in nasopharyngeal swabs
Time Frame
baseline, Day 4, Day 6, Day 10, Day 15
Title
Change of viral load compared to the baseline
Time Frame
baseline, Day 4, Day 6, Day 10, Day 15
Title
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time Frame
baseline, Day 4, Day 6, Day 10, Day 15
Title
Time to clinical sustained remission
Time Frame
Day 1 through Day 29
Title
Proportion of participants in clinical recovery/remission
Time Frame
Day 1 through Day 29
Title
Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
Time Frame
Day 1 through Day 29
Title
Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
Time Frame
Day 1 through Day 29
Title
Time to sustained clinical recovery of each COVID-19 targeted symptoms
Time Frame
Day 1 through Day 29
Title
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Day 1 through Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
The First Affiliated Hospital Of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

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Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19

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