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Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection

Primary Purpose

Coronavirus, Traditional Chinese Medicine

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Lianhua Qingwen capsules
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • International Convention and Exhibition Center Shelter HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lianhua Qingwen plus conventional therapy

Conventional therapy

Arm Description

Outcomes

Primary Outcome Measures

Incidence of all Infection events
Recurrence coronavirus infection or any new infection events

Secondary Outcome Measures

Duration of viral shedding
Negative conversion ratio
Positive conversion ratio
Duration of main symptoms before discharge
Disappearance ratio of main symptoms
Recurrence frequency of main clinical symptoms
Mean duration of main clinical symptoms
Heart rate
Heart rate
Heart rate
Blood pressure
both systolic and diastolic blood pressure
Blood pressure
both systolic and diastolic blood pressure
Blood pressure
both systolic and diastolic blood pressure
Infection events except SARS-CoV-2
Frequency of fever
Mean duration of fever
Duration of fever before discharge
Disappearance ratio of fever
Frequency of respiratory symptoms
Mean duration of respiratory symptoms
Duration of respiratory symptoms before discharge
Disappearance ratio of respiratory symptoms
Frequency of nasal congestion or runny nose
Mean duration of nasal congestion or runny nose
Duration of nasal congestion or runny nose before discharge
Disappearance ratio of nasal congestion or runny nose
Frequency of chest distress
Mean duration of chest distress
Duration of chest distress before discharge
Disappearance ratio of chest distress
Frequency of palpitations
Mean duration of palpitations
Duration of palpitations before discharge
Disappearance ratio of palpitations
Frequency of pharyngeal discomfort
Mean duration of pharyngeal discomfort
Duration of pharyngeal discomfort before discharge
Disappearance ratio of pharyngeal discomfort
Frequency of headache
Mean duration of headache
Duration of headache before discharge
Disappearance ratio of headache
Frequency of dizziness
Mean duration of dizziness
Duration of dizziness before discharge
Disappearance ratio of dizziness
Frequency of toothache
Mean duration of toothache
Duration of toothache before discharge
Disappearance ratio of toothache
Frequency of muscle soreness
Mean duration of muscle soreness
Duration of muscle soreness before discharge
Disappearance ratio of muscle soreness
Frequency of physical decline
Mean duration of physical decline
Duration of physical decline before discharge
Disappearance ratio of physical decline
Frequency of gastrointestinal symptoms
Mean duration of gastrointestinal symptoms
Duration of gastrointestinal symptoms before discharge
Disappearance ratio of gastrointestinal symptoms
Frequency of urinary symptoms
Mean duration of urinary symptoms
Duration of urinary symptoms before discharge
Disappearance ratio of urinary symptoms
Drug-related adverse events
Drug-related adverse events

Full Information

First Posted
November 1, 2022
Last Updated
November 14, 2022
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05625035
Brief Title
Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection
Official Title
Efficacy and Safety of Lianhua Qingwen in the Long-Term Rehabilitation of Patients With Coronavirus Infection: a Randomized, Open-Label, Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus, Traditional Chinese Medicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lianhua Qingwen plus conventional therapy
Arm Type
Experimental
Arm Title
Conventional therapy
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Lianhua Qingwen capsules
Intervention Description
Lianhua Qingwen capsules: 4 capsules once, three times daily
Primary Outcome Measure Information:
Title
Incidence of all Infection events
Description
Recurrence coronavirus infection or any new infection events
Time Frame
From discharge to 6 months
Secondary Outcome Measure Information:
Title
Duration of viral shedding
Time Frame
6 months
Title
Negative conversion ratio
Time Frame
7 days
Title
Positive conversion ratio
Time Frame
From discharge to 6 months
Title
Duration of main symptoms before discharge
Time Frame
6 months
Title
Disappearance ratio of main symptoms
Time Frame
7 days
Title
Recurrence frequency of main clinical symptoms
Time Frame
From discharge to 6 months
Title
Mean duration of main clinical symptoms
Time Frame
From discharge to 6 months
Title
Heart rate
Time Frame
6 months
Title
Heart rate
Time Frame
7 days
Title
Heart rate
Time Frame
Baseline
Title
Blood pressure
Description
both systolic and diastolic blood pressure
Time Frame
6 months
Title
Blood pressure
Description
both systolic and diastolic blood pressure
Time Frame
7 days
Title
Blood pressure
Description
both systolic and diastolic blood pressure
Time Frame
Baseline
Title
Infection events except SARS-CoV-2
Time Frame
From discharge to 6 months
Title
Frequency of fever
Time Frame
From discharge to 6 months
Title
Mean duration of fever
Time Frame
From discharge to 6 months
Title
Duration of fever before discharge
Time Frame
6 months
Title
Disappearance ratio of fever
Time Frame
7 days
Title
Frequency of respiratory symptoms
Time Frame
From discharge to 6 months
Title
Mean duration of respiratory symptoms
Time Frame
From discharge to 6 months
Title
Duration of respiratory symptoms before discharge
Time Frame
6 months
Title
Disappearance ratio of respiratory symptoms
Time Frame
7 days
Title
Frequency of nasal congestion or runny nose
Time Frame
From discharge to 6 months
Title
Mean duration of nasal congestion or runny nose
Time Frame
From discharge to 6 months
Title
Duration of nasal congestion or runny nose before discharge
Time Frame
6 months
Title
Disappearance ratio of nasal congestion or runny nose
Time Frame
7 days
Title
Frequency of chest distress
Time Frame
From discharge to 6 months
Title
Mean duration of chest distress
Time Frame
From discharge to 6 months
Title
Duration of chest distress before discharge
Time Frame
6 months
Title
Disappearance ratio of chest distress
Time Frame
7 days
Title
Frequency of palpitations
Time Frame
From discharge to 6 months
Title
Mean duration of palpitations
Time Frame
From discharge to 6 months
Title
Duration of palpitations before discharge
Time Frame
6 months
Title
Disappearance ratio of palpitations
Time Frame
7 days
Title
Frequency of pharyngeal discomfort
Time Frame
From discharge to 6 months
Title
Mean duration of pharyngeal discomfort
Time Frame
From discharge to 6 months
Title
Duration of pharyngeal discomfort before discharge
Time Frame
6 months
Title
Disappearance ratio of pharyngeal discomfort
Time Frame
7 days
Title
Frequency of headache
Time Frame
From discharge to 6 months
Title
Mean duration of headache
Time Frame
From discharge to 6 months
Title
Duration of headache before discharge
Time Frame
6 months
Title
Disappearance ratio of headache
Time Frame
7 days
Title
Frequency of dizziness
Time Frame
From discharge to 6 months
Title
Mean duration of dizziness
Time Frame
From discharge to 6 months
Title
Duration of dizziness before discharge
Time Frame
6 months
Title
Disappearance ratio of dizziness
Time Frame
7 days
Title
Frequency of toothache
Time Frame
From discharge to 6 months
Title
Mean duration of toothache
Time Frame
From discharge to 6 months
Title
Duration of toothache before discharge
Time Frame
6 months
Title
Disappearance ratio of toothache
Time Frame
7 days
Title
Frequency of muscle soreness
Time Frame
From discharge to 6 months
Title
Mean duration of muscle soreness
Time Frame
From discharge to 6 months
Title
Duration of muscle soreness before discharge
Time Frame
6 months
Title
Disappearance ratio of muscle soreness
Time Frame
7 days
Title
Frequency of physical decline
Time Frame
From discharge to 6 months
Title
Mean duration of physical decline
Time Frame
From discharge to 6 months
Title
Duration of physical decline before discharge
Time Frame
6 months
Title
Disappearance ratio of physical decline
Time Frame
7 days
Title
Frequency of gastrointestinal symptoms
Time Frame
From discharge to 6 months
Title
Mean duration of gastrointestinal symptoms
Time Frame
From discharge to 6 months
Title
Duration of gastrointestinal symptoms before discharge
Time Frame
6 months
Title
Disappearance ratio of gastrointestinal symptoms
Time Frame
7 days
Title
Frequency of urinary symptoms
Time Frame
From discharge to 6 months
Title
Mean duration of urinary symptoms
Time Frame
From discharge to 6 months
Title
Duration of urinary symptoms before discharge
Time Frame
6 months
Title
Disappearance ratio of urinary symptoms
Time Frame
7 days
Title
Drug-related adverse events
Time Frame
6 months
Title
Drug-related adverse events
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Panpan Hao, MD
Phone
86-18560086593
Email
panda.how@sdu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panpan Hao, MD
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
International Convention and Exhibition Center Shelter Hospital
City
Urumqi
State/Province
Xinjiang
ZIP/Postal Code
831400
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Panpan Hao, MD
Phone
86-18560086593
Email
panda.how@sdu.edu.cn

12. IPD Sharing Statement

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Lianhua Qingwen for the Rehabilitation of Patient With Coronavirus Infection

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