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NCT05620160 | COMPLETED | Mild to Moderate COVID-19

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

Guangdong Raynovent Biotech Co., Ltd

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

Mild to Moderate COVID-19

Intervention/treatment

RAY1216

Placebo

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1359 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2022-11-12
Estimated Primary Completion Date : 2023-01-19
Estimated Study Completion Date : 2023-03-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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 of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19

Location Details

NCT05620160

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

China, Guangdong

The First Affiliated Hospital Of Guangzhou Medical University

Guangzhou, Guangdong, China,