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COVID-19Phase 1/2NCT05092503

JINZHEN for Treatment of Mild to Moderate COVID-19

A Phase 1/2 study testing JINZHEN Granules for Oral Solution in people with COVID-19, run by Lianyungang Kanion Group, Ltd. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
COVID-19
What is being tested?
JINZHEN Granules for Oral Solution
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
10 sitesUnited States
Study dates
26 May 2022to 12 May 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Nursing women or women of pregnancy test positive or planning to be pregnant throughout the study period.
  • Psychiatric or cognitive illness (such as schizophrenia spectrum disorders, mood disorders, dementia, etc.) or alcohol abuse.
  • Participants who have received 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.
  • 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.
  • Participants with mild to moderate COVID-19 who would be eligible for another FDA authorized COVID-19 therapeutic.
  • Participants who are on sensitive substrates or substrates of a narrow therapeutic range for major cytochrome P450 and transporters.
  • Other conditions inappropriate for participation in this clinical trial considered by the investigators.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • F. Gabriel LLC

    Bayonne, New Jersey, 07002

  • Clearview Medical Research LLC

    Canyon Country, California, 91351

  • Carolina Institute for Clinical Research

    Fayetteville, North Carolina, 28303

  • AA Medical Research Center

    Flint, Michigan, 48504

  • Piedmont Research Partners

    Fort Mill, South Carolina, 29707

  • Family First Medical Research Center

    Hialeah Gardens, Florida, 33016

  • SMS Clinical Research

    Mesquite, Texas, 75149

  • LMG Research

    Miami, Florida, 33016

  • Frontier Clinical Research LLC

    Morgantown, West Virginia, 26505

  • Frontier Clinical Research LLC

    Smithfield, Pennsylvania, 15478

Other trials in United States

About this study

Official title: A Phase I/Ⅱ 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

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.

Read the 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
Being tested
JINZHEN Granules for Oral Solution, Placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JINZHEN Granules for Oral SolutionDrug

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

  • PlaceboDrug

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

Study groups in NCT05092503
Study groupRoleWhat they receive
JINZHEN low dose armExperimentalPatients will take 0.375 gram of JINZHEN Granules twice a day for 14 days.
Receives: Drug: JINZHEN Granules for Oral Solution
JINZHEN middle dose armExperimentalPatients will take 0.75 gram of JINZHEN Granules twice a day for 14 days.
Receives: Drug: JINZHEN Granules for Oral Solution
JINZHEN high dose armExperimentalPatients will take 1.5 gram of JINZHEN Granules twice a day for 14 days.
Receives: Drug: JINZHEN Granules for Oral Solution
Placebo armPlacebo comparatorPatients will take placebo granules twice a day for 14 days.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 28 days

Secondary outcomes (8)

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

    COVID-19 related hospitalization (defined as > 24 hours of acute care).

    COVID-19 related emergency room visit > 24 hours.

    All-cause mortality.

    Measured: up to Day 14 and 28

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

    Clinical recovery is defined as subjects with normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 2 days.

    Measured: up to Day 7 and 14

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

    Improvement is defined as symptoms scored 2 or 3 at baseline are scored 0 or 1, AND symptoms scored 1 at baseline are scored 0.

    Measured: up to Day 7, 14 and 28

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

    Resolution is defined as symptoms (except tiredness and cough) scored ≥ 1 at baseline are scored 0, AND tiredness or cough scored > 1 at baseline are scored ≤ 1.

    Measured: up to Day 7, 14 and 28

  5. Time to Clinical Recovery (TTCR).

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

    Measured: up to Day 7 and 14

  6. Time to improvement of each targeted symptom via participant questionnaire.

    Time to improvement is defined as the time from initiation of study treatment (active or placebo) until this symptom meets the definition of improvement AND sustained for at least 2 days.

    Measured: up to Day 7, 14 and 28

  7. Time to resolution of each targeted symptom via participant questionnaire.

    Time to resolution is defined as the time from initiation of study treatment (active or placebo) until this symptom meets the definition of resolution AND sustained for at least 2 days.

    Measured: up to Day 7, 14 and 28

  8. Viral load change

    Viral load change from screening to Day 8 and 15

    Measured: Day 8 and 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start26 May 2022
  3. Primary completion12 May 2023
  4. Study completion12 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092503
Sponsor's protocol ID
JZ-2001-01
Status last verified
Mar 2024
First submitted
6 Oct 2021
Last updated
20 Mar 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing JINZHEN Granules for Oral Solution in people with COVID-19, run by Lianyungang Kanion Group, Ltd. at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Median time to sustained symptom resolution within 28 days after beginning of administration. (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05092503.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.

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