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

Inclusion criteria

• 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.

Exclusion criteria

• 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.