Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection

NCT05625035 | Unknown Phase 4 DMC

• 1 other identifier: Lianhua Qingwen 2022
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of all Infection events

  Recurrence coronavirus infection or any new infection events

  From discharge to 6 months

Secondary Outcomes (68)

• Duration of viral shedding

  6 months

• Negative conversion ratio

  7 days

• Positive conversion ratio

  From discharge to 6 months

• Duration of main symptoms before discharge

  6 months

• Disappearance ratio of main symptoms

  7 days

Study Arms (2)

Lianhua Qingwen plus conventional therapy

EXPERIMENTAL

Drug: Lianhua Qingwen capsules

Conventional therapy

NO INTERVENTION

Interventions

Lianhua Qingwen capsules DRUG

Lianhua Qingwen capsules: 4 capsules once, three times daily

Lianhua Qingwen plus conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• confirmed SARS-CoV-2 Infection by virus testing;
• ≥18 years of age;
• informed consent provided.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

International Convention and Exhibition Center Shelter Hospital

Ürümqi, Xinjiang, 831400, China

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Study Officials

• Panpan Hao, MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Panpan Hao, MD

CONTACT

86-18560086593; panda.how@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 22, 2022
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

CN (1)