Mild to Moderate COVID-19Phase 3NCT05620160
Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19
A Phase 3 study testing RAY1216 in people with Mild to Moderate COVID-19, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mild to Moderate COVID-19
- What is being tested?
- RAY1216
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,359 participants
- Where
- 1 siteChina
- Study dates
- 12 Nov 2022to 28 Mar 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital Of Guangzhou Medical University
Guangzhou, Guangdong
About this study
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
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
- Being tested
- RAY1216, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1216Drug
RAY1216（tablet）
PlaceboDrug
placebo （tablet）
| Study group | Role | What they receive |
|---|---|---|
| RAY1216 | Experimental | Participants received 400mg RAY1216 tablet orally three times daily for 5 days. Receives: Drug: RAY1216 |
| Placebo | Placebo comparator | Participants received 400mg placebo orally three times daily for 5 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1 through Day 29
Secondary outcomes (12)
Proportion of participants who experience hospitalization or death cause by progression to severe disease
Measured: Day 1 through Day 29
Proportion of participants who experience death from any cause
Measured: Day 1 through Day 29
Proportion of participants who experience COVID-19 related hospitalization or death from any cause
Measured: Day 1 through Day 29
SARS-CoV-2 viral shedding time in nasopharyngeal swabs
Measured: baseline, Day 4, Day 6, Day 10, Day 15
Change of viral load compared to the baseline
Measured: baseline, Day 4, Day 6, Day 10, Day 15
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Measured: baseline, Day 4, Day 6, Day 10, Day 15
Time to clinical sustained remission
Measured: Day 1 through Day 29
Proportion of participants in clinical recovery/remission
Measured: Day 1 through Day 29
Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
Measured: Day 1 through Day 29
Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
Measured: Day 1 through Day 29
Time to sustained clinical recovery of each COVID-19 targeted symptoms
Measured: Day 1 through Day 29
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start12 Nov 2022
- Primary completion19 Jan 2023
- Study completion28 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild to Moderate COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620160
- Sponsor's protocol ID
- RAY1216-22-02
- Status last verified
- May 2023
- First submitted
- 4 Nov 2022
- Last updated
- 24 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38188690
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05620160
- Acronym / sponsor ID
- RAY1216-22-02
- Conditions
- Mild to Moderate COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,359 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Nov 2022 (actual)
- Primary completion
- 19 Jan 2023 (actual)
- Study completion
- 28 Mar 2023 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAY1216 | Experimental | Drug: RAY1216Participants received 400mg RAY1216 tablet orally three times daily for 5 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received 400mg placebo orally three times daily for 5 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RAY1216RAY1216（tablet） | Drug | RAY1216 |
| Placeboplacebo （tablet） | Drug | Placebo |
Primary outcome
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.
12 secondary outcomes
Proportion of participants who experience hospitalization or death cause by progression to severe disease
Time frame: Day 1 through Day 29
Proportion of participants who experience death from any cause
Time frame: 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
SARS-CoV-2 viral shedding time in nasopharyngeal swabs
Time frame: 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
Proportion of participants who are negative for SARS-CoV-2 nucleic acid test
Time frame: baseline, Day 4, Day 6, Day 10, Day 15
Time to clinical sustained remission
Time frame: Day 1 through Day 29
Proportion of participants in clinical recovery/remission
Time frame: Day 1 through Day 29
Time to sustained clinical recovery of 10 COVID-19 symptoms except cough
Time frame: Day 1 through Day 29
Time to sustained clinical recovery of COVID-19 respiratory and systemic symptoms
Time frame: Day 1 through Day 29
Time to sustained clinical recovery of each COVID-19 targeted symptoms
Time frame: Day 1 through Day 29
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Day 1 through Day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2023.
- Derived from this study: PubMed 38188690Zhan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RAY1216 in people with Mild to Moderate COVID-19, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to sustained clinical recovery of 11 COVID-19 symptoms (time frame: Day 1 through Day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05620160, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2023.