Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection

A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection

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.

Study Overview

• Status: Recruiting
• Conditions: COVID-19; Child, Only
• Intervention / Treatment: Drug: Jinzhen oral liquid or Jinhuaqinggan granules

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.

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Qian Dong, Professor; Phone Number: 0532-82911885; Email: 18661801885@163.com

Study Locations

• China
  • Shandong
    • Qingdao, Shandong, China, 266003
      • Recruiting
      • Phase I Clinical Research Center
      • Contact: yu Cao, Doctor; Phone Number: 86-0532-82911767; Email: caoyu@qdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: treatment group; Jinzhen oral liquid(for 3 years old, 10 ml once, twice a day; for 4 to 7 years old, 10 ml a time, 3 times a day; for 8 to 18 years old, 15 ml a time, 3 times a day)	Drug: Jinzhen oral liquid or Jinhuaqinggan granules; Jinzhen oral liquid, for 3 years old, 10 ml once, twice a day; for 4 to 7 years old, 10 ml a time, 3 times a day; for 8 to 18 years old, 15 ml a time, 3 times a day.The dosage and usage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition. The drugs were medicated for 14 days.
Active Comparator: control group; The usage and dosage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition and recorded truthfully	Drug: Jinzhen oral liquid or Jinhuaqinggan granules; Jinzhen oral liquid, for 3 years old, 10 ml once, twice a day; for 4 to 7 years old, 10 ml a time, 3 times a day; for 8 to 18 years old, 15 ml a time, 3 times a day.The dosage and usage of Jinhua Qinggan granules were determined by the researcher according to the patient's condition. The drugs were medicated for 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First negative time of COVID-19	First negative time of COVID-19	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical symptom disappearance rate/time	Clinical symptom disappearance rate/time	up to 6 months
The hospitalization time	The hospitalization time	up to 6 months
Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness Incidence of conversion to severe/critical illness	Incidence of conversion to severe/critical illness	up to 6 months

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2022
• Primary Completion (Anticipated): September 10, 2022
• Study Completion (Anticipated): March 17, 2023

Study Registration Dates

• First Submitted: August 17, 2022
• First Submitted That Met QC Criteria: August 17, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Actual): August 19, 2022
• Last Update Submitted That Met QC Criteria: August 17, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: JZ-2022-nCoV-0.1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No