Lianhua Qingke for the Rehabilitation of Patient With Omicron Infection

Study Overview
=================
Brief Summary
-----------------
The patients with Omicron infection usually have fever, respiratory symptoms, tachycardia, 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 Omicron 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 Qingke tablets in patients with Omicron infection. The duration of viral shedding and symptoms will be evaluated. 6-month follow-up will be performed to evaluate the effect of Lianhua Qingke on long-term rehabilitation of all symptoms induced by Omicron infection, as well as infection events.

Official Title
-----------------
Efficacy and Safety of Lianhua Qingke in the Long-term Rehabilitation of Patients With Omicron Infection: a 6-month Follow-up Study

Conditions
-----------------
Coronavirus, Traditional Chinese Medicine

Intervention / Treatment
-----------------
* Drug: Lianhua Qingke tablets


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed Omicron 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lianhua Qingke plus conventional therapy<br> | Drug: Lianhua Qingke tablets<br>* Lianhua Qingke tablets: 4 tablets once, three times daily<br>|
| No Intervention: Conventional therapy<br> | |

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 |
| --- | --- | --- |
| Duration of viral shedding | Nucleic acid negative conversion time before discharge | 6 months | 
| Negative conversion ratio | Nucleic acid negative conversion ratio | 7 days | 
| Positive conversion ratio | Nucleic acid 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 | 
| 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 | 
| Infection events except SARS-CoV-2 |  | From discharge to 6 months | 
| Heart rates |  | 6 months | 
| Heart rates |  | Baseline | 
| Heart rates |  | 7 days | 
| Blood pressure | both systolic and diastolic blood pressure | 6 months | 
| Blood pressure | both systolic and diastolic blood pressure | Baseline | 
| Blood pressure | both systolic and diastolic blood pressure | 7 days | 
| Incidence of drug-related adverse events |  | 7 days | 
| Incidence of drug-related adverse events |  | 6 months |