JINZHEN for Treatment of Mild to Moderate COVID-19

NCT05092503 | Completed Phase 1 FDA Drug

• 1 other identifier: JZ-2001-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Median time to sustained symptom resolution within 28 days after beginning of administration.

  * Sustained symptom resolution is defined as absences of symptoms (except for mild fatigue or mild cough) over at least 2 days. * Time to sustained symptom resolution is defined as the time from initiation of study treatment (active or placebo) until symptom resolution.

  28 days

Secondary Outcomes (8)

• Proportion of participants who experience any of these events within 14 and 28 days after beginning of administration.

  up to Day 14 and 28

• Proportion of participants with clinical recovery of symptomatic reliefs within 7 days and 14 days after beginning of administration.

  up to Day 7 and 14

• Proportion of participants demonstrating improvement of each targeted symptom via participant questionnaire.

  up to Day 7, 14 and 28

• Proportion of participants demonstrating resolution of each targeted symptom via participant questionnaire.

  up to Day 7, 14 and 28

• Time to Clinical Recovery (TTCR).

  up to Day 7 and 14

Study Arms (4)

JINZHEN low dose arm

EXPERIMENTAL

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

Drug: JINZHEN Granules for Oral Solution

JINZHEN middle dose arm

EXPERIMENTAL

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

Drug: JINZHEN Granules for Oral Solution

JINZHEN high dose arm

EXPERIMENTAL

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

Drug: JINZHEN Granules for Oral Solution

Placebo arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

JINZHEN Granules for Oral Solution DRUG

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

JINZHEN high dose arm; JINZHEN low dose arm; JINZHEN middle dose arm

Placebo DRUG

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

Placebo arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult ≥ 18 years and ≤ 50 years of age, BMI \< 30 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℃ (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).
• 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.

You may not qualify if:

• 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 ˂ 93% on room air at sea level, or respiratory frequency ˃ 30 breaths/minute, or heart rate ≥ 125 per minute.
• 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, bronchopulmonary dysplasia and other basic pulmonary diseases. Have chronic pulmonary diseases such as pulmonary embolism and pulmonary hypertension at present.
• 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.
• ALT/AST \> 3×ULN, TBIL ≥ 1.5×ULN, creatinine ≥ 1.5×ULN.
• Patients with recurrent diarrhea or abnormal intestinal function that are not caused by COVID-19.
• Patients with a history of type 1 or type 2 diabetes, OR with glycosylated hemoglobin (HbA1c) level ≥ 6.5% during screening.
• Patients with hypertension at screening (systolic blood pressure ≥ 140 mmHg and/or diastolic blood pressure ≥ 90 mmHg).
• 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.
• Suffering from diseases that seriously affect the immune system, such as HIV infection, splenectomy, organ or blood stem cell transplantation, etc.
• Participants who received systemic corticosteroids or other immunosuppressive medications within 14 days before screening.
• Participants with positive results of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) at screening period.
• Participants who are using any herb supplements/products.
• Participants who are currently using anti-virus drugs.

Sponsors & Collaborators

• Lianyungang Kanion Group, Ltd.: lead

Study Sites (10)

Clearview Medical Research LLC

Canyon Country, California, 91351, United States

Location

Family First Medical Research Center

Hialeah Gardens, Florida, 33016, United States

Location

LMG Research

Miami, Florida, 33016, United States

Location

AA Medical Research Center

Flint, Michigan, 48504, United States

Location

F. Gabriel LLC

Bayonne, New Jersey, 07002, United States

Location

Carolina Institute for Clinical Research

Fayetteville, North Carolina, 28303, United States

Location

Frontier Clinical Research LLC

Smithfield, Pennsylvania, 15478, United States

Location

Piedmont Research Partners

Fort Mill, South Carolina, 29707, United States

Location

SMS Clinical Research

Mesquite, Texas, 75149, United States

Location

Frontier Clinical Research LLC

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

COVID-19

Interventions

Solutions

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Zhu

  Jiangsu Kanion Pharmaceutical Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 25, 2021
• Study Start: May 26, 2022
• Primary Completion: May 12, 2023
• Study Completion: May 12, 2023
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (10)