Clinical trial NCT04723524: Jinhua Qinggan Granules in the Treatment of COVID-19
Official title: Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Effectiveness and Safety of Jinhua Qinggan Granules (JHQG) for the Treatment of COVID 19 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: University of Karachi
Sponsor class: OTHER
Collaborators: name: Indus Hospital and Health Network
name: Dow University Hospital, Mission Rd, Gulzar-e-Hijri, Scheme 33, Karachi. Tel: (92-21) 38771111
name: Dr. Ruth K.M. Pfau Civil Hospital, Karachi
First posted: 2021-01-25
Enrollment: 402
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial
Primary purpose: TREATMENT

Brief summary: The clinical trial is designed to be randomized, double blind, placebo controlled, to evaluate the effectiveness and safety of Jinhua Qinggan granules (JHQG) on mild-category patients of COVID-19 in Pakistani population with the age limit of 18-75 years, at10th day comprehensive follow-up. The informed consent form must be signed by the subjects before their participation in the trial.

Detailed description: The course of treatment is 10 days, and the visit points are set on the 1st and 10th day, in which 10th day is follow-up. Patients will be assessed by using seven-category ordinal scale and clinical signs and symptoms on 1st and 10th day. If the subject recovers and checks out within 10 days, they will be recorded once before checking out. All effectiveness and safety inspection items will be done once before the trial and once at follow-up point i.e. 10th day. In case of any new abnormality or abnormality aggravation after the treatment, should be followed up until normal or stable.

Eligibility criteria: Inclusion Criteria:

* 1) Between the ages of 18-75 years, both male and female.
* 2) Confirmed Coronavirus infection by real time RT-PCR.
* 3) Mild cases of Coronavirus having main symptoms with minimum 2 grade (as mentioned in 7.1.6).
* 4) The subject has signed the informed consent form;

Exclusion Criteria:

* 1) Younger than 18 years or older than 75 years.
* 2) Patients with moderate or critical Coronavirus infection confirmed by real time RT-PCR; cases meeting any of the following criteria:

  1. Lung lesions
  2. Respiratory failure and requiring mechanical ventilation
  3. Shock
  4. With other organ failure that requires ICU cares.
* 3) Severe primary health conditions associated with cardiovascular, cerebrovascular, pulmonary, hepatic, renal, endocrine and hematological diseases, hematopoietic system (above grade II of cardiac function; ALT \& AST are 1.5 times higher than the normal value; Creatinine above the upper limit of normal value) and mental illness or serious diseases affecting their survival, such as cancer or AIDS;
* 4) With severe cardiopulmonary dysfunction, cardiopulmonary insufficiency.
* 5) Subjects, who took other antiviral, antibacterial, cough relieving, expectorant and antiasthmatic drugs within 3 days prior to the visit (including β2 receptor agonists, anticholinergic agents, theophylline drugs, glucocorticoids, expectorant and Chinese Medicine.)
* 6) Allergic individuals and those who are known to be allergic to experimental drugs
* 7) Pregnant women, lactating women or fertile women who are ready to conceive in 3 months.
* 8) Subject, who has participated in the past 1 month in another clinical study.
* 9) Subjects who are not suitable for the clinical trial based on investigators' judgment.

Primary outcomes:
measure: Change in Primary symptom (cough)
timeFrame: 10th day of treatment.
measure: Change in Primary symptom (Fever)
timeFrame: 10th day of treatment
measure: Time for Negative COVID-19 Test
timeFrame: 2nd follow-up on 10th day or 3rd follow-up for RT-PCR test on 15th day if positive on 10th day
Secondary outcomes:
measure: Body temperature
timeFrame: 10 days
measure: white blood cells count
timeFrame: during the 10-day course of treatment
measure: C-reactive protein test
timeFrame: during the 10-day course of treatment
measure: ferritin test
timeFrame: during the 10-day course of treatment
measure: Radiology
timeFrame: during the 10-day course of treatment
measure: Quality of life assessment:
timeFrame: during the 10-day course of treatment
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Center for Bioequivalence Studies and Clinical Research (CBSCR), ICCBS, university of Karachi
Study officials:
affiliation: CBSCR , ICCBS, University of Karachi
name: Muhammad Raza Shah
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang Q, Cao F, Wang Y, Xu X, Sun Y, Li J, Qi X, Sun S, Ji G, Song B. The efficacy and safety of Jinhua Qinggan granule (JHQG) in the treatment of coronavirus disease 2019 (COVID-19): A protocol for systematic review and meta analysis. Medicine (Baltimore). 2020 Jun 12;99(24):e20531. doi: 10.1097/MD.0000000000020531.
citation: Shah MR, Fatima S, Khan SN, Ullah S, Himani G, Wan K, Lin T, Lau JYN, Liu Q, Lam DSC. Jinhua Qinggan granules for non-hospitalized COVID-19 patients: A double-blind, placebo-controlled, and randomized controlled trial. Front Med (Lausanne). 2022 Aug 1;9:928468. doi: 10.3389/fmed.2022.928468. eCollection 2022.