JINZHEN for Treatment of Mild to Moderate COVID-19

NCT ID: NCT05092503

Last Updated: 2024-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-26
• Study Completion Date: 2023-05-12

Brief 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.

Detailed Description

The study is a randomized, double-blind, placebo-controlled, proof of concept study with four groups (low dose treatment group, middle dose treatment group, high dose treatment group, and placebo group). Study eligibility will be assessed during screening. Study participants will be randomized in a 3:1 ratio to receive JINZHEN Granules for Oral Solution or placebo granules for 14 days.

During the 14-day clinical study, participants will be assessed daily at home using e-diary to collect clinical data and in person visit on Day 7 and Day14. All subjects will undergo a series of efficacy, safety, and laboratory assessments. Clinical observation endpoints will be assessed at day 7 and day 14. Interim analysis will be performed to evaluate efficacy and safety of 7-day and 14-day treatment.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

JINZHEN low dose arm

Patients will take 0.375 gram of JINZHEN Granules twice a day for 14 days.

Group Type: EXPERIMENTAL

JINZHEN Granules for Oral Solution

Intervention Type: DRUG

JINZHEN granules will be dissolved in drinking water and administered orally.

JINZHEN middle dose arm

Patients will take 0.75 gram of JINZHEN Granules twice a day for 14 days.

Group Type: EXPERIMENTAL

JINZHEN Granules for Oral Solution

Intervention Type: DRUG

JINZHEN granules will be dissolved in drinking water and administered orally.

JINZHEN high dose arm

Patients will take 1.5 gram of JINZHEN Granules twice a day for 14 days.

Group Type: EXPERIMENTAL

JINZHEN Granules for Oral Solution

Intervention Type: DRUG

JINZHEN granules will be dissolved in drinking water and administered orally.

Placebo arm

Patients will take placebo granules twice a day for 14 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo granules will be dissolved in drinking water and administered orally.

Interventions

JINZHEN Granules for Oral Solution

JINZHEN granules will be dissolved in drinking water and administered orally.

Intervention Type: DRUG

Placebo

Placebo granules will be dissolved in drinking water and administered orally.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Adult ≥ 18 years and ≤ 50 years of age, BMI < 30 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℃ (100.4℉ oral temperature) or ≥ 38.6℃ (101.48℉ tympanic temperature) within 48 hours before screening; and at least one of respiratory rate > 24 breaths/minute or cough (scored ≥ 2 via participant questionnaire).

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 ˂ 93% on room air at sea level, or respiratory frequency ˃ 30 breaths/minute, or heart rate ≥ 125 per minute.

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, bronchopulmonary dysplasia and other basic pulmonary diseases. Have chronic pulmonary diseases such as pulmonary embolism and pulmonary hypertension at present.

5. Have any other active infectious diseases. Such as influenza, bacterial infections of the respiratory system (suppurative tonsillitis, acute tracheobronchitis, active tuberculosis, 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 that are not caused by COVID-19.

8. Patients with a history of type 1 or type 2 diabetes, OR with glycosylated hemoglobin (HbA1c) level ≥ 6.5% during screening.

9. Patients with hypertension at screening (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg).

10. 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 and heart conditions (e.g., heart failure [New York heart association (NYHA) ≥ grade 3], coronary artery disease, cardiomyopathies), down syndrome, sickle cell disease, cystic fibrosis, thalassemia, etc.

11. Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ or blood stem cell transplantation, etc.

12. Participants who received systemic corticosteroids or other immunosuppressive medications within 14 days before screening.

13. Participants with positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) at screening period.

14. Participants who are using any herb supplements/products.

15. Participants who are currently using anti-virus drugs.

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

17. Psychiatric or cognitive illness (such as schizophrenia spectrum disorders, mood disorders, dementia, etc.) or alcohol abuse.

18. Participants who have received any interventional experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation.

19. Participants unable to take oral medications.

20. Participants who plan to receive live attenuated vaccine within 1 month prior to the first administration of the study drug or during the study period.

21. Participants with mild to moderate COVID-19 who would be eligible for another FDA authorized COVID-19 therapeutic.

22. Participants who are on sensitive substrates or substrates of a narrow therapeutic range for major cytochrome P450 and transporters.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lianyungang Kanion Group, Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhu

Role: STUDY_DIRECTOR

Jiangsu Kanion Pharmaceutical Co., Ltd

Locations

Clearview Medical Research LLC

Canyon Country, California, United States

Family First Medical Research Center

Hialeah Gardens, Florida, United States

LMG Research

Miami, Florida, United States

AA Medical Research Center

Flint, Michigan, United States

F. Gabriel LLC

Bayonne, New Jersey, United States

Carolina Institute for Clinical Research

Fayetteville, North Carolina, United States

Frontier Clinical Research LLC

Smithfield, Pennsylvania, United States

Piedmont Research Partners

Fort Mill, South Carolina, United States

SMS Clinical Research

Mesquite, Texas, United States

Frontier Clinical Research LLC

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

JZ-2001-01

Identifier Type: -

Identifier Source: org_study_id