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

May 22, 2023 updated by: Guangdong Raynovent Biotech Co., Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1359

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to sustained clinical recovery of 11 COVID-19 symptoms
Time Frame: Day 1 through Day 29
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
SARS-CoV-2 viral shedding time in nasopharyngeal swabs
Time Frame: baseline, Day 4, Day 6, Day 10, Day 15
baseline, Day 4, Day 6, Day 10, Day 15
Change of viral load compared to the baseline
Time Frame: baseline, Day 4, Day 6, Day 10, Day 15
baseline, Day 4, Day 6, Day 10, Day 15
Time to clinical sustained remission
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Proportion of participants in clinical recovery/remission
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Proportion of participants who experience hospitalization or death cause by progression to severe disease
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Proportion of participants who experience death from any cause
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Proportion of participants who experience COVID-19 related hospitalization or death from any cause
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time Frame: baseline, Day 4, Day 6, Day 10, Day 15
baseline, Day 4, Day 6, Day 10, Day 15
Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
Time Frame: Day 1 through Day 29
Day 1 through Day 29
Time to sustained clinical recovery of each COVID-19 targeted symptoms
Time Frame: Day 1 through Day 29
Day 1 through Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guangdong Raynovent Biotech Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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