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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05625035
Other study ID # Lianhua Qingwen 2022
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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, MD
Phone 86-18560086593
Email panda.how@sdu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The patients with coronavirus infection usually have fever, respiratory symptoms, 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 coronavirus 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 Qingwen capsules in patients with coronavirus infection. The duration of viral shedding and symptoms before discharge, as well as the negative conversion ratio and disappearance ratio of main symptoms after 7-day treatment, will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingwen on all infection events and the long-term rehabilitation of the symptoms induced by coronavirus infection.


Recruitment information / eligibility

Status Recruiting
Enrollment 4000
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 SARS-CoV-2 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.

Study Design


Intervention

Drug:
Lianhua Qingwen capsules
Lianhua Qingwen capsules: 4 capsules 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 6 months
Secondary Negative conversion ratio 7 days
Secondary 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 Heart rate 6 months
Secondary Heart rate 7 days
Secondary Heart rate Baseline
Secondary Blood pressure both systolic and diastolic blood pressure 6 months
Secondary Blood pressure both systolic and diastolic blood pressure 7 days
Secondary Blood pressure both systolic and diastolic blood pressure Baseline
Secondary Infection events except SARS-CoV-2 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 Drug-related adverse events 6 months
Secondary Drug-related adverse events 7 days
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