JINZHEN for Treatment of Mild to Moderate COVID-19

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Proof-of-concept Study to Evaluate the Safety and Efficacy of JINZHEN Granules for Oral Solution in Participants With Mild to Moderate COVID-19

Conditions
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COVID-19

Intervention / Treatment
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* Drug: JINZHEN Granules for Oral Solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult ≥ 18 years of age at time of enrollment. 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. 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. Initial onset of signs/symptoms for ≤ 5 days prior to randomization. Participant provides written informed consent prior to initiation of any study procedures. Participant is willing to accept randomization to any assigned treatment arm. And participant understands and agrees to comply with planned study procedures. Exclusion Criteria: SARS-CoV-2 infection confirmed participants who are currently hospitalized or are expected to need hospitalization (for COVID-19 within 48 hours of randomization). 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%. Require mechanical ventilation or anticipated impending need for mechanical ventilation. 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. 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. ALT/AST > 3×ULN, TBIL ≥ 1.5×ULN, creatinine ≥ 1.5×ULN. Patients with recurrent diarrhea or abnormal intestinal function. Patients with electrolyte disturbances during screening. 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. Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ transplantation, etc. Participants who are using any herb supplements. Nursing women or women of pregnancy test positive or planning to be pregnant throughout the study period. Psychiatric or cognitive illness or recreational drug/alcohol use. Participants Receipt of any interventional experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation. Participants unable to take oral medications. Other conditions inappropriate for participation in this clinical trial considered by the investigators.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JINZHEN low dose arm<br>Patients will take 0.375 gram of JINZHEN Granules twice a day for 14 days. | Drug: JINZHEN Granules for Oral Solution<br>* JINZHEN granules will be dissolved in drinking water and administered orally.<br>* Other names: JINZHEN;|
| Experimental: JINZHEN middle dose arm<br>Patients will take 0.75 gram of JINZHEN Granules twice a day for 14 days. | Drug: JINZHEN Granules for Oral Solution<br>* JINZHEN granules will be dissolved in drinking water and administered orally.<br>* Other names: JINZHEN;|
| Experimental: JINZHEN high dose arm<br>Patients will take 1.5 gram of JINZHEN Granules twice a day for 14 days. | Drug: JINZHEN Granules for Oral Solution<br>* JINZHEN granules will be dissolved in drinking water and administered orally.<br>* Other names: JINZHEN;|
| Placebo Comparator: Placebo arm<br>Patients will take placebo granules twice a day for 14 days. | Drug: Placebo<br>* Placebo granules will be dissolved in drinking water and administered orally.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants who experience any of following events within 14 days after beginning of administration. | COVID-19 related hospitalization (defined as ≥ 24 hours of acute care) COVID-19 related emergency room visit | 14 days | 
| Proportion of participants with clinical recovery of symptomatic reliefs within 14 days after beginning of administration. | - Clinical recovery is defined as subjects with normalization of fever, respiratory rate, and oxygen saturation sustained for at least 72 hours. Fever, respiratory rate, and oxygen saturation will be combined to report using a score system. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Clinical Recovery (TTCR). | - TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until clinical recovery. | up to 14 days | 
| Viral load change. | - Viral load change from the time of screening to Day 7 and Day 14. | up to14 days | 
| Adverse events. | - Proportion of participants experiencing adverse events, including laboratory assessments. | 28 days |