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

Guangdong Raynovent Biotech

Status and phase: Completed; Phase 3

Conditions: Mild to Moderate COVID-19

Treatments: Drug: Placebo; Drug: RAY1216

Study type: Interventional

Funder types: Industry

Identifiers

NCT05620160

RAY1216-22-02

Details and patient eligibility

About

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.

Enrollment: 1,359 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,359 participants in 2 patient groups, including a placebo group

RAY1216

Experimental group

Description:

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

Treatment:

Drug: RAY1216

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo