Lianhua Qingke for the Rehabilitation of Patient With Omicron Infection

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 30, 2023

Interventions

  • Drug: Lianhua Qingke tablets
    • Lianhua Qingke tablets: 4 tablets once, three times daily

Arms, Groups and Cohorts

  • Experimental: Lianhua Qingke plus conventional therapy
  • No Intervention: Conventional therapy

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of all Infection events
    • Time Frame: From discharge to 6 months
    • Recurrence coronavirus infection or any new infection events

Secondary Measures

  • Duration of viral shedding
    • Time Frame: 6 months
    • Nucleic acid negative conversion time before discharge
  • Negative conversion ratio
    • Time Frame: 7 days
    • Nucleic acid negative conversion ratio
  • Positive conversion ratio
    • Time Frame: From discharge to 6 months
    • Nucleic acid positive conversion ratio
  • Duration of main symptoms before discharge
    • Time Frame: 6 months
  • Disappearance ratio of main symptoms
    • Time Frame: 7 days
  • Recurrence frequency of main clinical symptoms
    • Time Frame: From discharge to 6 months
  • Mean duration of main clinical symptoms
    • Time Frame: From discharge to 6 months
  • Frequency of fever
    • Time Frame: From discharge to 6 months
  • Mean duration of fever
    • Time Frame: From discharge to 6 months
  • Duration of fever before discharge
    • Time Frame: 6 months
  • Disappearance ratio of fever
    • Time Frame: 7 days
  • Frequency of respiratory symptoms
    • Time Frame: From discharge to 6 months
  • Mean duration of respiratory symptoms
    • Time Frame: From discharge to 6 months
  • Duration of respiratory symptoms before discharge
    • Time Frame: 6 months
  • Disappearance ratio of respiratory symptoms
    • Time Frame: 7 days
  • Frequency of nasal congestion or runny nose
    • Time Frame: From discharge to 6 months
  • Mean duration of nasal congestion or runny nose
    • Time Frame: From discharge to 6 months
  • Duration of nasal congestion or runny nose before discharge
    • Time Frame: 6 months
  • Disappearance ratio of nasal congestion or runny nose
    • Time Frame: 7 days
  • Frequency of chest distress
    • Time Frame: From discharge to 6 months
  • Mean duration of chest distress
    • Time Frame: From discharge to 6 months
  • Duration of chest distress before discharge
    • Time Frame: 6 months
  • Disappearance ratio of chest distress
    • Time Frame: 7 days
  • Frequency of palpitations
    • Time Frame: From discharge to 6 months
  • Mean duration of palpitations
    • Time Frame: From discharge to 6 months
  • Duration of palpitations before discharge
    • Time Frame: 6 months
  • Disappearance ratio of palpitations
    • Time Frame: 7 days
  • Frequency of pharyngeal discomfort
    • Time Frame: From discharge to 6 months
  • Mean duration of pharyngeal discomfort
    • Time Frame: From discharge to 6 months
  • Duration of pharyngeal discomfort before discharge
    • Time Frame: 6 months
  • Disappearance ratio of pharyngeal discomfort
    • Time Frame: 7 days
  • Frequency of headache
    • Time Frame: From discharge to 6 months
  • Mean duration of headache
    • Time Frame: From discharge to 6 months
  • Duration of headache before discharge
    • Time Frame: 6 months
  • Disappearance ratio of headache
    • Time Frame: 7 days
  • Frequency of dizziness
    • Time Frame: From discharge to 6 months
  • Mean duration of dizziness
    • Time Frame: From discharge to 6 months
  • Duration of dizziness before discharge
    • Time Frame: 6 months
  • Disappearance ratio of dizziness
    • Time Frame: 7 days
  • Frequency of toothache
    • Time Frame: From discharge to 6 months
  • Mean duration of toothache
    • Time Frame: From discharge to 6 months
  • Duration of toothache before discharge
    • Time Frame: 6 months
  • Disappearance ratio of toothache
    • Time Frame: 7 days
  • Frequency of muscle soreness
    • Time Frame: From discharge to 6 months
  • Mean duration of muscle soreness
    • Time Frame: From discharge to 6 months
  • Duration of muscle soreness before discharge
    • Time Frame: 6 months
  • Disappearance ratio of muscle soreness
    • Time Frame: 7 days
  • Frequency of physical decline
    • Time Frame: From discharge to 6 months
  • Mean duration of physical decline
    • Time Frame: From discharge to 6 months
  • Duration of physical decline before discharge
    • Time Frame: 6 months
  • Disappearance ratio of physical decline
    • Time Frame: 7 days
  • Frequency of gastrointestinal symptoms
    • Time Frame: From discharge to 6 months
  • Mean duration of gastrointestinal symptoms
    • Time Frame: From discharge to 6 months
  • Duration of gastrointestinal symptoms before discharge
    • Time Frame: 6 months
  • Disappearance ratio of gastrointestinal symptoms
    • Time Frame: 7 days
  • Frequency of urinary symptoms
    • Time Frame: From discharge to 6 months
  • Mean duration of urinary symptoms
    • Time Frame: From discharge to 6 months
  • Duration of urinary symptoms before discharge
    • Time Frame: 6 months
  • Disappearance ratio of urinary symptoms
    • Time Frame: 7 days
  • Infection events except SARS-CoV-2
    • Time Frame: From discharge to 6 months
  • Heart rates
    • Time Frame: 6 months
  • Heart rates
    • Time Frame: Baseline
  • Heart rates
    • Time Frame: 7 days
  • Blood pressure
    • Time Frame: 6 months
    • both systolic and diastolic blood pressure
  • Blood pressure
    • Time Frame: Baseline
    • both systolic and diastolic blood pressure
  • Blood pressure
    • Time Frame: 7 days
    • both systolic and diastolic blood pressure
  • Incidence of drug-related adverse events
    • Time Frame: 7 days
  • Incidence of drug-related adverse events
    • Time Frame: 6 months

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Qilu Hospital of Shandong University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Pan-Pan Hao, Professor – Qilu Hospital of Shandong University
  • Overall Contact(s)
    • Panpan Hao, 86-18560086593, panda.how@sdu.edu.cn

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