A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19

• Status: Not yet recruiting
• Trial end date: 2023-04-30
• Target enrollment: 0
• Participant gender: All

Summary

This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo.

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

Details

• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 1. Participants ≥18 years of age 2.Initial positive Severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)tested by Reverse Transcription-Polymerase Chain Reaction(RT-PCR) or rapid antigen test within protocol specified time prior to the first dose of study drug collected from any respiratory tract specimen 3.With signs/symptoms attributable to COVID-19 prior to the day of the first dose of study drug.

4. At least one of the following symptoms of COVID-19 present within 24 hours prior to the first dose of study drug and meeting severity.

5. Has mild or moderate COVID-19. 6. Participants agree to take highly effective contraceptive measures from signing the informed consent to at least 1 month after the last dose of study intervention.

7. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

8. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

Exclusion Criteria:

1. Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).

2. Known medical history of active liver disease.

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

4. Compromised immune system.

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

6. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.

7. 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.

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

9. Other medical or psychiatric conditions including recent or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

10. Clinical signs indicative of severe systemic illness with COVID-19

11. Treatment with antivirals against SARS-CoV-2 prior to randomization.

12. Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during study treatment and for 4 days after the last dose of study drug.

13. Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 21 days prior to randomization or during study treatment .

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

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

16. Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19.

Prior/Concurrent Clinical Study Experience:

17. Previous administration with any investigational drug or vaccine within 30 days or 5 half-lives prior to randomization.

18. Known prior participation in this trial or other trial involving SIM0417.

Other Exclusions:

19. Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test in the pre-dose examinations:

20. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.