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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
JINZHEN granules will be dissolved in drinking water and administered orally.
Placebo granules will be dissolved in drinking water and administered orally.
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
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.
Time frame: 28 days
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.
Time frame: 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.
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.
Time frame: up to Day 7 and 14
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.
Time frame: up to Day 7, 14 and 28
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.
Time frame: up to Day 7, 14 and 28
Time to Clinical Recovery (TTCR).
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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
TTCR is defined as the time from initiation of study treatment (active or placebo) until clinical recovery.
Time frame: up to Day 7 and 14
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.
Time frame: up to Day 7, 14 and 28
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.
Time frame: up to Day 7, 14 and 28
Viral load change
Viral load change from screening to Day 8 and 15
Time frame: Day 8 and 15