Clinical trial NCT05507489: Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection
Official title: A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Child, Only
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2022-08-19
Enrollment: 240
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Jinzhen oral liquid and Jinhuaqinggan Granules were used in the treatment and the control group for 14 days, respectively, to evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection.

Detailed description: To evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection by shortening the time of first negative turn of virus, improving clinical symptoms and shortening hospital stay, and to observe the safety of Jinzhen oral liquid in clinical application.A total of 240 Patients aged 3 to 18 years old or asymptomatic infected persons who meet the diagnostic criteria for novel coronavirus infection in the COVID-19 Diagnosis and Treatment Protocol (Trial Version 9)were planned to be enrolled. Jinzhen oral liquid was used in the treatment group, and Jinhuaqinggan Granules was used in the control group, with 120 patients in each group. The subjects took the medication for 14 days (the medication could be stopped in advance if they reached the discharge criteria), and were followed up for 14 days after discontinuation. During the treatment period, the subjects' vital signs, chest imaging examination, novel coronavirus nucleic acid test, blood routine, urine routine, liver and kidney function, and condition and symptoms should be monitored on the follow-up day specified in the protocol.

Eligibility criteria: Inclusion Criteria:

* 1. Meet the diagnostic criteria of novel coronavirus infected patients in COVID-19 Diagnosis and Treatment Protocol (Trial Version 9);

  2. Asymptomatic infection or clinical classification of mild or common type;

  3. Aged from 3 to 18 years;

  4. The informed consent process was in accordance with the regulations, and the legal guardian or the children (≥8 years old) signed the informed consent form.

Exclusion Criteria:

* 1. Meet the severe/critical early warning indicators;

  2. Children who used proprietary Chinese medicine of the same type for more than 3 days before enrollment;

  3. Children with diarrhea.

Primary outcomes:
measure: First negative time of COVID-19
timeFrame: up to 6 months
Secondary outcomes:
measure: Clinical symptom disappearance rate/time
timeFrame: up to 6 months
measure: The hospitalization time
timeFrame: up to 6 months
measure: Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
References: