Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection

Efficacy and Safety of Lianhua Qingwen in the Long-Term Rehabilitation of Patients With Coronavirus Infection: a Randomized, Open-Label, Comparative Study

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.

Study Overview

• Status: Recruiting
• Conditions: Coronavirus; Traditional Chinese Medicine
• Intervention / Treatment: Drug: Lianhua Qingwen capsules

• Study Type: Interventional
• Enrollment (Anticipated): 4000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Panpan Hao, MD; Phone Number: 86-18560086593; Email: panda.how@sdu.edu.cn

Study Locations

• China
  • Xinjiang
    • Urumqi, Xinjiang, China, 831400
      • Recruiting
      • International Convention and Exhibition Center Shelter Hospital
      • Contact: Panpan Hao, MD; Phone Number: 86-18560086593; Email: panda.how@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lianhua Qingwen plus conventional therapy	Drug: Lianhua Qingwen capsules; Lianhua Qingwen capsules: 4 capsules once, three times daily
No Intervention: Conventional therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of all Infection events	Recurrence coronavirus infection or any new infection events	From discharge to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart rate		Baseline
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
Recurrence frequency of main clinical symptoms		From discharge to 6 months
Mean duration of main clinical symptoms		From discharge to 6 months
Heart rate		6 months
Heart rate		7 days
Blood pressure	both systolic and diastolic blood pressure	6 months
Blood pressure	both systolic and diastolic blood pressure	7 days
Blood pressure	both systolic and diastolic blood pressure	Baseline
Infection events except SARS-CoV-2		From discharge to 6 months
Frequency of fever		From discharge to 6 months
Mean duration of fever		From discharge to 6 months
Duration of fever before discharge		6 months
Disappearance ratio of fever		7 days
Frequency of respiratory symptoms		From discharge to 6 months
Mean duration of respiratory symptoms		From discharge to 6 months
Duration of respiratory symptoms before discharge		6 months
Disappearance ratio of respiratory symptoms		7 days
Frequency of nasal congestion or runny nose		From discharge to 6 months
Mean duration of nasal congestion or runny nose		From discharge to 6 months
Duration of nasal congestion or runny nose before discharge		6 months
Disappearance ratio of nasal congestion or runny nose		7 days
Frequency of chest distress		From discharge to 6 months
Mean duration of chest distress		From discharge to 6 months
Duration of chest distress before discharge		6 months
Disappearance ratio of chest distress		7 days
Frequency of palpitations		From discharge to 6 months
Mean duration of palpitations		From discharge to 6 months
Duration of palpitations before discharge		6 months
Disappearance ratio of palpitations		7 days
Frequency of pharyngeal discomfort		From discharge to 6 months
Mean duration of pharyngeal discomfort		From discharge to 6 months
Duration of pharyngeal discomfort before discharge		6 months
Disappearance ratio of pharyngeal discomfort		7 days
Frequency of headache		From discharge to 6 months
Mean duration of headache		From discharge to 6 months
Duration of headache before discharge		6 months
Disappearance ratio of headache		7 days
Frequency of dizziness		From discharge to 6 months
Mean duration of dizziness		From discharge to 6 months
Duration of dizziness before discharge		6 months
Disappearance ratio of dizziness		7 days
Frequency of toothache		From discharge to 6 months
Mean duration of toothache		From discharge to 6 months
Duration of toothache before discharge		6 months
Disappearance ratio of toothache		7 days
Frequency of muscle soreness		From discharge to 6 months
Mean duration of muscle soreness		From discharge to 6 months
Duration of muscle soreness before discharge		6 months
Disappearance ratio of muscle soreness		7 days
Frequency of physical decline		From discharge to 6 months
Mean duration of physical decline		From discharge to 6 months
Duration of physical decline before discharge		6 months
Disappearance ratio of physical decline		7 days
Frequency of gastrointestinal symptoms		From discharge to 6 months
Mean duration of gastrointestinal symptoms		From discharge to 6 months
Duration of gastrointestinal symptoms before discharge		6 months
Disappearance ratio of gastrointestinal symptoms		7 days
Frequency of urinary symptoms		From discharge to 6 months
Mean duration of urinary symptoms		From discharge to 6 months
Duration of urinary symptoms before discharge		6 months
Disappearance ratio of urinary symptoms		7 days
Drug-related adverse events		6 months
Drug-related adverse events		7 days

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Panpan Hao, MD, Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Coronavirus Infections
• Other Study ID Numbers: Lianhua Qingwen 2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No