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

A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study of RAY1216 Tablets in Patients With Mild to Moderate SARS-CoV-2 Infection

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 Overview

• Status: Completed
• Conditions: Mild to Moderate COVID-19
• Intervention / Treatment: Drug: RAY1216; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1359
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAY1216; Participants received 400mg RAY1216 tablet orally three times daily for 5 days.	Drug: RAY1216; RAY1216（tablet）
Placebo Comparator: Placebo; Participants received 400mg placebo orally three times daily for 5 days.	Drug: Placebo; placebo （tablet）

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2022
• Primary Completion (Actual): January 19, 2023
• Study Completion (Actual): March 28, 2023

Study Registration Dates

• First Submitted: November 4, 2022
• First Submitted That Met QC Criteria: November 11, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: RAY1216-22-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No