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

• Sponsor: The Affiliated Hospital of Qingdao University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05507489
• Collaborator: (none)
• Enrollment: 240
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 20.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Child, Only	Drug: Jinzhen oral liquid or Jinhuaqinggan granules	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Randomized Controlled Multicenter Clinical Study on the Effectiveness of Jinzhen Oral Liquid in Treating Children With Novel Coronavirus Infection
• Actual Study Start Date: Mar 18, 2022
• Anticipated Primary Completion Date: Sep 10, 2022
• Anticipated Study Completion Date: Mar 17, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. First negative time of COVID-19 [up to 6 months]

   First negative time of COVID-19

Secondary Outcome Measures

1. Clinical symptom disappearance rate/time [up to 6 months]

   Clinical symptom disappearance rate/time

2. The hospitalization time [up to 6 months]

   The hospitalization time

3. 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]

   Incidence of conversion to severe/critical illness

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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

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

2. Aged from 3 to 18 years;

3. 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;

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

2. Children with diarrhea.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Clinical Research Center	Qingdao	Shandong	China	266003

Sponsors and Collaborators

• The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Hospital of Qingdao University
• ClinicalTrials.gov Identifier: NCT05507489
• Other Study ID Numbers: JZ-2022-nCoV-0.1
• First Posted: Aug 19, 2022
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19

Study Results

No Results Posted as of Aug 19, 2022