Lianhua Qingke for the Rehabilitation of Patient With Omicron Infection

Last updated: November 14, 2022
Sponsor: Qilu Hospital of Shandong University
Overall Status: Active - Recruiting

Phase

4

Condition

Coronavirus

Treatment

N/A

Clinical Study ID

NCT05625022
Lianhua Qingke and Omicron
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • confirmed Omicron infection by virus testing;
  • ≥18 years of age;
  • informed consent provided.

Exclusion

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 refluxdisease, and abnormal lung development;
  • asthma treated daily, chronic airway disease, respiratory bacterial infections (e.g.,purulent tonsillitis), acute tracheobronchitis, sinusitis, otitis media, and furtherrespiratory tract pathologies potentially affecting the trial's data analysis;
  • common pulmonary diseases (e.g., severe pulmonary interstitial lesions andbronchiectasis) confirmed by chest CT;
  • severe pneumonia requiring ventilator use;
  • previous or present diseases potentially affecting trial participation or influencingstudy 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 Design

Total Participants: 2000
Study Start date:
November 01, 2022
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • International Convention and Exhibition Center Shelter Hospital

    Urumqi, Xinjiang 831400
    China

    Active - Recruiting

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