Study of GST-HG171/Ritonavir Compared With Placebo in Patients With Mild to Moderate COVID-19

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess the efficacy and safety of GST-HG171/Ritonavir in the treatment of mild to moderate COVID-19.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fujian Akeylink Biotechnology Co., Ltd.
• Treatments: Ritonavir

Criteria

Inclusion Criteria:

1. Participants ≥18 years of age.

2. Confirmed SARS-CoV-2 infection 4 days prior to randomization.

3. The subjects were classified as mild/moderate type COVID-19.

4. Initial onset 2 of 11 COVID-19 symptoms within 48 hours before randomization,respiratory and feverish symptoms must be included.

5. Participants who are willing and able to comply with the protocol for treatment plan, virological testing, laboratory testing and other study procedures.

6. Fertile participants must agree to take effective contraceptive measures.

Exclusion Criteria:

1. Has hypersensitivity or other contraindication to any of the components of the study interventions.

2. Patients with severe or critical COVID-19.

3. Active liver disease, or obvious abnormal liver function (ALT or AST ≥ 3ULN, or total bilirubin ≥ 1.5ULN).

4. Receiving dialysis or have known moderate to severe renal impairment.

5. Compromised immune system.

6. Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease.

7. Suspected or confirmed concurrent active systemic infection other than COVID-19.

8. Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life-threatening within 30 days prior to study entry, as determined by the investigator.

9. Treatment with antivirals against SARS-CoV-2 within 14 days prior to randomization.

10. Current or expected use of strong CYP3A4 inducers, inhibitors or medications that are highly dependent on CYP3A4 for clearance.

11. Has received or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment.

12. Has received any SARS-CoV-2 vaccine within 3 months prior to randomization.

13. Participating in another interventional clinical study with an investigational compound or device.

14. Pregnant, lactating women or those with a positive pregnancy test.

15. Previous administration with any investigational drug within 3 months before the study drug administration.

16. Participants who are judged by the investigator to be unsuitable to participate in this study.