Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| 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）
|
Outcome Measures
Primary Outcome Measures
- Time to sustained clinical recovery of 11 COVID-19 symptoms [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.
Secondary Outcome Measures
- Proportion of participants with severe COVID-19 disease or death [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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Participants who provide written informed consent before the trial, and fully understand the trial content, process and possible adverse reactions.
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Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures.
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Male or female participants aged 18-75 (including 18 and 75 years old).
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Confirmed SARS-CoV-2 infection 120 hours prior to randomization.
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Initial onset of COVID-19 symptoms/signs within 48 hours before randomization.
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Fertile participants must agree to take effective contraceptive measures.
Exclusion Criteria:
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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.
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Difficulty swallowing or a history of gastrointestinal diseases that seriously affect drug absorption.
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Active liver disease, or obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥ 2ULN).
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WBC >1ULN, or NEU <0.5ⅹ109/L.
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Receiving dialysis or have known moderate to severe renal impairment (eGFR<60mL/min/1.73m2).
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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.
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Prior or anticipated receipt of any vaccine within 28 days prior to enrollment and during study period.
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Use of antivirals against SARS-CoV-2 within 7 days prior to enrollment.
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Weight≤40kg.
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Pregnant, lactating women or those with a positive pregnancy test (sterilized or postmenopausal women may not have a pregnancy test).
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Previous administration with any investigational drug within 3 months before the study drug administration.
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Participants who are judged by the investigator to be unsuitable to participate in this study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Guangdong Raynovent Biotech Co., Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RAY1216-22-02