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JINZHEN for Treatment of Mild to Moderate COVID-19

Primary Purpose

COVID-19

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

JINZHEN Granules for Oral Solution

Placebo

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

JINZHEN low dose arm

JINZHEN middle dose arm

JINZHEN high dose arm

Placebo arm

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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

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.

Secondary Outcome Measures

Time to Clinical Recovery (TTCR).

- TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until clinical recovery.

Viral load change.

- Viral load change from the time of screening to Day 7 and Day 14.

Adverse events.

- Proportion of participants experiencing adverse events, including laboratory assessments.

Full Information

NCT ID

NCT05092503

First Posted

October 6, 2021

Last Updated

October 21, 2021

Sponsor

Lianyungang Kanion Group, Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05092503

Brief Title

JINZHEN for Treatment of Mild to Moderate COVID-19

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 2022 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

March 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lianyungang Kanion Group, Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

JINZHEN low dose arm

Arm Type

Experimental

Arm Description

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

Arm Title

JINZHEN middle dose arm

Arm Type

Experimental

Arm Description

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

Arm Title

JINZHEN high dose arm

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo arm

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

JINZHEN Granules for Oral Solution

Other Intervention Name(s)

JINZHEN

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Proportion of participants who experience any of following events within 14 days after beginning of administration.

Description

COVID-19 related hospitalization (defined as ≥ 24 hours of acute care) COVID-19 related emergency room visit

Time Frame

14 days

Title

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

Description

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Time to Clinical Recovery (TTCR).

Description

- TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until clinical recovery.

Time Frame

up to 14 days

Title

Viral load change.

Description

- Viral load change from the time of screening to Day 7 and Day 14.

Time Frame

up to14 days

Title

Adverse events.

Description

- Proportion of participants experiencing adverse events, including laboratory assessments.

Time Frame

28 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

JINZHEN for Treatment of Mild to Moderate COVID-19

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