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

Mild to Moderate COVID-19 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05620160
• Other study ID #: RAY1216-22-02
• Status: Completed
• Phase: Phase 3
• Start date: November 12, 2022
• Est. completion date: March 28, 2023

Study information

• Verified date: May 2023
• Source: Guangdong Raynovent Biotech Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1359
• Est. completion date: March 28, 2023
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 <0.5?109/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.

Related Conditions & MeSH terms

• COVID-19
• Mild to Moderate COVID-19

Intervention

Drug:
• RAY1216
RAY1216(tablet)
• Placebo
placebo (tablet)

Locations

Country	Name	City	State
China	The First Affiliated Hospital Of Guangzhou Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Raynovent Biotech Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 through Day 29
Secondary	Proportion of participants who experience hospitalization or death cause by progression to severe disease		Day 1 through Day 29
Secondary	Proportion of participants who experience death from any cause		Day 1 through Day 29
Secondary	Proportion of participants who experience COVID-19 related hospitalization or death from any cause		Day 1 through Day 29
Secondary	SARS-CoV-2 viral shedding time in nasopharyngeal swabs		baseline, Day 4, Day 6, Day 10, Day 15
Secondary	Change of viral load compared to the baseline		baseline, Day 4, Day 6, Day 10, Day 15
Secondary	Proportion of participants who are negative for SARS-CoV-2 nucleic acid test		baseline, Day 4, Day 6, Day 10, Day 15
Secondary	Time to clinical sustained remission		Day 1 through Day 29
Secondary	Proportion of participants in clinical recovery/remission		Day 1 through Day 29
Secondary	Time to sustained clinical recovery of 10 COVID-19 symptoms except cough		Day 1 through Day 29
Secondary	Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms		Day 1 through Day 29
Secondary	Time to sustained clinical recovery of each COVID-19 targeted symptoms		Day 1 through Day 29
Secondary	Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)		Day 1 through Day 29