Study of SHEN26 Capsule in Patients With Mild to Moderate COVID-19

Exclusion Criteria

• •1. Subjects diagnosed with severe or critical COVID-19 at screening and/or baseline according to the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) or who, in the judgment of the investigator, are likely to progress to severe/critical COVID-19 prior to randomization.
• •2. Subjects are expected to be transferred to another hospital prior to randomization or within 72 hours of enrollment.
• •3. Subjects with SpO2 ≤ 93% or PaO2/FiO2 ≤ 300 mmHg, or respiratory rate ≥ 30 breaths/minute, or heart rate ≥ 125 beats/minute while breathing room air at sea level for 24 hours prior to dosing.
• •4. Subjects who require mechanical ventilation or are expected to require mechanical ventilation.
• •5. Subjects infected with COVID-19 within 3 months prior to dosing.
• •6. Subjects who have received SARS-CoV-2 monoclonal antibody treatment or prophylaxis within 30 days prior to dosing.
• •7. Subjects who have received COVID-19 convalescent plasma or COVID-19 human immunoglobulin treatment within 30 days prior to dosing.
• •8. Subjects who have received treatment or prophylaxis with antiviral drugs (e.g., Paxlovid, Molnupiravir, Remdesivir, lopinavir/ritonavir combination, ribavirin, chloroquine, hydroxychloroquine, etc.) within 30 days prior to dosing.
• •9. Subjects who have received systemic or inhaled steroids for COVID-19 treatment within 30 days prior to dosing (except for long-term stable dose treatment with concomitant chronic disease and no dose increase).
• •10. Subjects who are on dialysis.
• •11. Subjects with a history of drug or other allergies or who, in the investigator's judgment, may be allergic to the test drug or any component of the test drug.
• •12. Subjects who have undergone major organ surgery (excluding puncture biopsy, tracheotomy, gastrostomy, etc.) or significant trauma within 28 days prior to dosing or who require elective surgery during the trial period.
• •13. Subjects with a life-threatening illness within 28 days prior to dosing, or other clinically significant illness as judged by the investigator.
• •14. Cardiovascular disease meeting any of the following criteria:
• •* Prior history of myocardial infarction within 12 months;
• •* Unstable angina pectoris;
• •* Clinically significant and uncontrollable cardiac arrhythmia;
• •* A history of stroke or transient ischemic attack requiring medication in the past 12 months;
• •* Congestive heart failure based on NYHA classification ≥ Class II;
• •* Restrictive edema of ≥ grade 3 (including respiratory, chest and mediastinal disease: laryngeal edema, pulmonary edema; skin and subcutaneous tissue disease: peripheral edema);
• •* Clinically uncontrollable hypertension.
• •15. Subjects with suspected or confirmed active systemic infections, such as bacterial, fungal, viral or other infections (other than COVID-19 infections), or with conditions that, in the investigator's judgment, would affect the assessment of endpoints in this study.
• •16. Subjects with known HIV infection, or human immunodeficiency virus antibody (HIV-Ab) positive at screening.
• •17. Subjects with liver disease meeting any of the following criteria: