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

NCT05620160 | Completed Phase 3

• 1 other identifier: RAY1216-22-02
• Study Type: interventional
• Target: 1,359
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• 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

• 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

Study Arms (2)

RAY1216

EXPERIMENTAL

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

Drug: RAY1216

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

RAY1216 DRUG

RAY1216（tablet）

RAY1216

Placebo DRUG

placebo （tablet）

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Related Publications (1)

• Zhan Y, Lin Z, Liang J, Sun R, Li Y, Lin B, Ge F, Lin L, Lu H, Su L, Xiang T, Pan H, Huang C, Deng Y, Wang F, Xu R, Chen D, Zhang P, Tong J, Wang X, Meng Q, Zheng Z, Ou S, Guo X, Yao H, Yu T, Li W, Zhang Y, Jiang M, Fang Z, Song Y, Chen R, Luo J, Kang C, Liang S, Li H; other Collaborative Institutes; Zheng J, Zhong N, Yang Z. Leritrelvir for the treatment of mild or moderate COVID-19 without co-administered ritonavir: a multicentre randomised, double-blind, placebo-controlled phase 3 trial. EClinicalMedicine. 2023 Dec 14;67:102359. doi: 10.1016/j.eclinm.2023.102359. eCollection 2024 Jan.

  PMID: 38188690 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2022
• First Posted: November 17, 2022
• Study Start: November 12, 2022
• Primary Completion: January 19, 2023
• Study Completion: March 28, 2023
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CN (1)