Clinical trial NCT05625035: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronavirus
Traditional Chinese Medicine
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-11-22
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Incidence of all Infection events
timeFrame: From discharge to 6 months
Secondary outcomes:
measure: Duration of viral shedding
timeFrame: 6 months
measure: Negative conversion ratio
timeFrame: 7 days
measure: Positive conversion ratio
timeFrame: From discharge to 6 months
measure: Duration of main symptoms before discharge
timeFrame: 6 months
measure: Disappearance ratio of main symptoms
timeFrame: 7 days
measure: Recurrence frequency of main clinical symptoms
timeFrame: From discharge to 6 months
measure: Mean duration of main clinical symptoms
timeFrame: From discharge to 6 months
measure: Heart rate
timeFrame: 6 months
measure: Heart rate
timeFrame: 7 days
measure: Heart rate
timeFrame: Baseline
measure: Blood pressure
timeFrame: 6 months
measure: Blood pressure
timeFrame: 7 days
measure: Blood pressure
timeFrame: Baseline
measure: Infection events except SARS-CoV-2
timeFrame: From discharge to 6 months
measure: Frequency of fever
timeFrame: From discharge to 6 months
measure: Mean duration of fever
timeFrame: From discharge to 6 months
measure: Duration of fever before discharge
timeFrame: 6 months
measure: Disappearance ratio of fever
timeFrame: 7 days
measure: Frequency of respiratory symptoms
timeFrame: From discharge to 6 months
measure: Mean duration of respiratory symptoms
timeFrame: From discharge to 6 months
measure: Duration of respiratory symptoms before discharge
timeFrame: 6 months
measure: Disappearance ratio of respiratory symptoms
timeFrame: 7 days
measure: Frequency of nasal congestion or runny nose
timeFrame: From discharge to 6 months
measure: Mean duration of nasal congestion or runny nose
timeFrame: From discharge to 6 months
measure: Duration of nasal congestion or runny nose before discharge
timeFrame: 6 months
measure: Disappearance ratio of nasal congestion or runny nose
timeFrame: 7 days
measure: Frequency of chest distress
timeFrame: From discharge to 6 months
measure: Mean duration of chest distress
timeFrame: From discharge to 6 months
measure: Duration of chest distress before discharge
timeFrame: 6 months
measure: Disappearance ratio of chest distress
timeFrame: 7 days
measure: Frequency of palpitations
timeFrame: From discharge to 6 months
measure: Mean duration of palpitations
timeFrame: From discharge to 6 months
measure: Duration of palpitations before discharge
timeFrame: 6 months
measure: Disappearance ratio of palpitations
timeFrame: 7 days
measure: Frequency of pharyngeal discomfort
timeFrame: From discharge to 6 months
measure: Mean duration of pharyngeal discomfort
timeFrame: From discharge to 6 months
measure: Duration of pharyngeal discomfort before discharge
timeFrame: 6 months
measure: Disappearance ratio of pharyngeal discomfort
timeFrame: 7 days
measure: Frequency of headache
timeFrame: From discharge to 6 months
measure: Mean duration of headache
timeFrame: From discharge to 6 months
measure: Duration of headache before discharge
timeFrame: 6 months
measure: Disappearance ratio of headache
timeFrame: 7 days
measure: Frequency of dizziness
timeFrame: From discharge to 6 months
measure: Mean duration of dizziness
timeFrame: From discharge to 6 months
measure: Duration of dizziness before discharge
timeFrame: 6 months
measure: Disappearance ratio of dizziness
timeFrame: 7 days
measure: Frequency of toothache
timeFrame: From discharge to 6 months
measure: Mean duration of toothache
timeFrame: From discharge to 6 months
measure: Duration of toothache before discharge
timeFrame: 6 months
measure: Disappearance ratio of toothache
timeFrame: 7 days
measure: Frequency of muscle soreness
timeFrame: From discharge to 6 months
measure: Mean duration of muscle soreness
timeFrame: From discharge to 6 months
measure: Duration of muscle soreness before discharge
timeFrame: 6 months
measure: Disappearance ratio of muscle soreness
timeFrame: 7 days
measure: Frequency of physical decline
timeFrame: From discharge to 6 months
measure: Mean duration of physical decline
timeFrame: From discharge to 6 months
measure: Duration of physical decline before discharge
timeFrame: 6 months
measure: Disappearance ratio of physical decline
timeFrame: 7 days
measure: Frequency of gastrointestinal symptoms
timeFrame: From discharge to 6 months
measure: Mean duration of gastrointestinal symptoms
timeFrame: From discharge to 6 months
measure: Duration of gastrointestinal symptoms before discharge
timeFrame: 6 months
measure: Disappearance ratio of gastrointestinal symptoms
timeFrame: 7 days
measure: Frequency of urinary symptoms
timeFrame: From discharge to 6 months
measure: Mean duration of urinary symptoms
timeFrame: From discharge to 6 months
measure: Duration of urinary symptoms before discharge
timeFrame: 6 months
measure: Disappearance ratio of urinary symptoms
timeFrame: 7 days
measure: Drug-related adverse events
timeFrame: 6 months
measure: Drug-related adverse events
timeFrame: 7 days
Other outcomes:
Locations:
city: Urumqi
country: China
facility: International Convention and Exhibition Center Shelter Hospital
state: Xinjiang
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Panpan Hao, MD
role: PRINCIPAL_INVESTIGATOR
References: