JINZHEN for Treatment of Mild to Moderate COVID-19

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

JINZHEN is a botanical drug that contains eight chemical constituents extracted from plant, mineral and animal origin raw materials. This study is to evaluate the safety and efficacy of JINZHEN Granules for Oral Solution compared to placebo for treatment of mild to moderate COVID-19 outpatients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lianyungang Kanion Group, Ltd.

Criteria

Inclusion Criteria:

1. Adult ≥ 18 years of age at time of enrollment.

2. Have presence of SARS-CoV-2 infection confirmed by reverse transcription polymerase chain reaction (RT-PCR) test with sample collection ≤ 3 days prior to randomization.

3. Fever ≥ 38.0℃ (oral temperature) or ≥ 38.6℃ (tympanic temperature) within 48 hours before screening; and at least one of respiratory rate > 24/min or cough.

4. Initial onset of signs/symptoms for ≤ 5 days prior to randomization.

5. Participant provides written informed consent prior to initiation of any study procedures.

6. Participant is willing to accept randomization to any assigned treatment arm. And participant understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. SARS-CoV-2 infection confirmed participants who are currently hospitalized or are expected to need hospitalization (for COVID-19 within 48 hours of randomization).

2. Participants who have SpO2 < 94%, or arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg, or respiratory frequency > 30/min, or lung infiltrates > 50%.

3. Require mechanical ventilation or anticipated impending need for mechanical ventilation.

4. Pre-existing pulmonary conditions such as chronic obstructive pulmonary disease or asthma. Imaging confirmed the existence of severe lung interstitial lesions, bronchiectasis and other basic pulmonary diseases.

5. Have any other active infectious diseases. Such as influenza, bacterial infections of the respiratory system (suppurative tonsillitis, acute tracheobronchitis, etc.) and other respiratory diseases affecting the evaluation of clinical trials.

6. ALT/AST > 3×ULN, TBIL ≥ 1.5×ULN, creatinine ≥ 1.5×ULN.

7. Patients with recurrent diarrhea or abnormal intestinal function.

8. Patients with electrolyte disturbances during screening.

9. Have any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study. Such as, unresectable malignant tumor, blood disease, active bleeding, cachexia, nervous system disease, endocrine system disease, cardiovascular disease (NYHA ≥ grade 3), etc.

10. Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ transplantation, etc.

11. Participants who are using any herb supplements.

12. Nursing women or women of pregnancy test positive or planning to be pregnant throughout the study period.

13. Psychiatric or cognitive illness or recreational drug/alcohol use.

14. Participants Receipt of any interventional experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.

15. Participants unable to take oral medications.

16. Other conditions inappropriate for participation in this clinical trial considered by the investigators.