Lianhua Qingke for the Rehabilitation of Patient With Omicron Infection

Coronavirus Clinical Trial

Official title:

Efficacy and Safety of Lianhua Qingke in the Long-term Rehabilitation of Patients With Omicron Infection: a 6-month Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625022
• Other study ID #: Lianhua Qingke and Omicron
• Status: Recruiting
• Phase: Phase 4
• Start date: November 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: Qilu Hospital of Shandong University
• Contact: Panpan Hao
• Phone: 86-18560086593
• Email: panda.how[@]sdu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The patients with Omicron infection usually have fever, respiratory symptoms, tachycardia, headache, toothache, muscle soreness, physical decline, and so on, while others are asymptomatic patients. It is urgent to find drugs to improve the long-term rehabilitation of symptomatic patients with Omicron infection and decrease the duration of viral shedding in both symptomatic and asymptomatic patients. This study aims to investigate the efficacy and safety of Lianhua Qingke tablets in patients with Omicron infection. The duration of viral shedding and symptoms will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingke on long-term rehabilitation of all symptoms induced by Omicron infection, as well as infection events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• confirmed Omicron infection by virus testing;
• =18 years of age;
• informed consent provided.

Exclusion Criteria:

• overt bacterial infection in the respiratory tract resulting from common pathologies, including primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory malformation, congenital heart disease, gastroesophageal reflux disease, and abnormal lung development;
• asthma treated daily, chronic airway disease, respiratory bacterial infections (e.g., purulent tonsillitis), acute tracheobronchitis, sinusitis, otitis media, and further respiratory tract pathologies potentially affecting the trial's data analysis;
• common pulmonary diseases (e.g., severe pulmonary interstitial lesions and bronchiectasis) confirmed by chest CT;
• severe pneumonia requiring ventilator use;
• previous or present diseases potentially affecting trial participation or influencing study outcome, based on the investigator's judgment;
• pregnancy or lactation in women;
• participation in a clinical study in the past 3 months;
• history of allergy to =2 drugs or foods or known allergy to the drug's constituents.

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Infections
• Traditional Chinese Medicine

Intervention

Drug:
• Lianhua Qingke tablets
Lianhua Qingke tablets: 4 tablets once, three times daily

Locations

Country	Name	City	State
China	International Convention and Exhibition Center Shelter Hospital	Urumqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of all Infection events	Recurrence coronavirus infection or any new infection events	From discharge to 6 months
Secondary	Duration of viral shedding	Nucleic acid negative conversion time before discharge	6 months
Secondary	Negative conversion ratio	Nucleic acid negative conversion ratio	7 days
Secondary	Positive conversion ratio	Nucleic acid positive conversion ratio	From discharge to 6 months
Secondary	Duration of main symptoms before discharge		6 months
Secondary	Disappearance ratio of main symptoms		7 days
Secondary	Recurrence frequency of main clinical symptoms		From discharge to 6 months
Secondary	Mean duration of main clinical symptoms		From discharge to 6 months
Secondary	Frequency of fever		From discharge to 6 months
Secondary	Mean duration of fever		From discharge to 6 months
Secondary	Duration of fever before discharge		6 months
Secondary	Disappearance ratio of fever		7 days
Secondary	Frequency of respiratory symptoms		From discharge to 6 months
Secondary	Mean duration of respiratory symptoms		From discharge to 6 months
Secondary	Duration of respiratory symptoms before discharge		6 months
Secondary	Disappearance ratio of respiratory symptoms		7 days
Secondary	Frequency of nasal congestion or runny nose		From discharge to 6 months
Secondary	Mean duration of nasal congestion or runny nose		From discharge to 6 months
Secondary	Duration of nasal congestion or runny nose before discharge		6 months
Secondary	Disappearance ratio of nasal congestion or runny nose		7 days
Secondary	Frequency of chest distress		From discharge to 6 months
Secondary	Mean duration of chest distress		From discharge to 6 months
Secondary	Duration of chest distress before discharge		6 months
Secondary	Disappearance ratio of chest distress		7 days
Secondary	Frequency of palpitations		From discharge to 6 months
Secondary	Mean duration of palpitations		From discharge to 6 months
Secondary	Duration of palpitations before discharge		6 months
Secondary	Disappearance ratio of palpitations		7 days
Secondary	Frequency of pharyngeal discomfort		From discharge to 6 months
Secondary	Mean duration of pharyngeal discomfort		From discharge to 6 months
Secondary	Duration of pharyngeal discomfort before discharge		6 months
Secondary	Disappearance ratio of pharyngeal discomfort		7 days
Secondary	Frequency of headache		From discharge to 6 months
Secondary	Mean duration of headache		From discharge to 6 months
Secondary	Duration of headache before discharge		6 months
Secondary	Disappearance ratio of headache		7 days
Secondary	Frequency of dizziness		From discharge to 6 months
Secondary	Mean duration of dizziness		From discharge to 6 months
Secondary	Duration of dizziness before discharge		6 months
Secondary	Disappearance ratio of dizziness		7 days
Secondary	Frequency of toothache		From discharge to 6 months
Secondary	Mean duration of toothache		From discharge to 6 months
Secondary	Duration of toothache before discharge		6 months
Secondary	Disappearance ratio of toothache		7 days
Secondary	Frequency of muscle soreness		From discharge to 6 months
Secondary	Mean duration of muscle soreness		From discharge to 6 months
Secondary	Duration of muscle soreness before discharge		6 months
Secondary	Disappearance ratio of muscle soreness		7 days
Secondary	Frequency of physical decline		From discharge to 6 months
Secondary	Mean duration of physical decline		From discharge to 6 months
Secondary	Duration of physical decline before discharge		6 months
Secondary	Disappearance ratio of physical decline		7 days
Secondary	Frequency of gastrointestinal symptoms		From discharge to 6 months
Secondary	Mean duration of gastrointestinal symptoms		From discharge to 6 months
Secondary	Duration of gastrointestinal symptoms before discharge		6 months
Secondary	Disappearance ratio of gastrointestinal symptoms		7 days
Secondary	Frequency of urinary symptoms		From discharge to 6 months
Secondary	Mean duration of urinary symptoms		From discharge to 6 months
Secondary	Duration of urinary symptoms before discharge		6 months
Secondary	Disappearance ratio of urinary symptoms		7 days
Secondary	Infection events except SARS-CoV-2		From discharge to 6 months
Secondary	Heart rates		6 months
Secondary	Heart rates		Baseline
Secondary	Heart rates		7 days
Secondary	Blood pressure	both systolic and diastolic blood pressure	6 months
Secondary	Blood pressure	both systolic and diastolic blood pressure	Baseline
Secondary	Blood pressure	both systolic and diastolic blood pressure	7 days
Secondary	Incidence of drug-related adverse events		7 days
Secondary	Incidence of drug-related adverse events		6 months