Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection

NCT ID: NCT05625035

Last Updated: 2022-11-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 4000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Coronavirus; Traditional Chinese Medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lianhua Qingwen plus conventional therapy

Group Type: EXPERIMENTAL

Lianhua Qingwen capsules

Intervention Type: DRUG

Lianhua Qingwen capsules: 4 capsules once, three times daily

Conventional therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lianhua Qingwen capsules

Lianhua Qingwen capsules: 4 capsules once, three times daily

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Pan-Pan Hao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Panpan Hao, MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

International Convention and Exhibition Center Shelter Hospital

Ürümqi, Xinjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Panpan Hao, MD

Role: CONTACT

panda.how@sdu.edu.cn

86-18560086593

Facility Contacts

Panpan Hao, MD

Role: primary

panda.how@sdu.edu.cn

86-18560086593

Other Identifiers

Lianhua Qingwen 2022

Identifier Type: -

Identifier Source: org_study_id