Lianhua Qingke for the Rehabilitation of Patient With Omicron Infection

NCT05625022 | Unknown Phase 4 DMC

• 1 other identifier: Lianhua Qingke and Omicron
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus; Traditional Chinese Medicine

Outcome Measures

Primary Outcomes (1)

• Incidence of all Infection events

  Recurrence coronavirus infection or any new infection events

  From discharge to 6 months

Secondary Outcomes (68)

• Duration of viral shedding

  6 months

• Negative conversion ratio

  7 days

• Positive conversion ratio

  From discharge to 6 months

• Duration of main symptoms before discharge

  6 months

• Disappearance ratio of main symptoms

  7 days

Study Arms (2)

Lianhua Qingke plus conventional therapy

EXPERIMENTAL

Drug: Lianhua Qingke tablets

Conventional therapy

NO INTERVENTION

Interventions

Lianhua Qingke tablets DRUG

Lianhua Qingke tablets: 4 tablets once, three times daily

Lianhua Qingke plus conventional therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

International Convention and Exhibition Center Shelter Hospital

Ürümqi, Xinjiang, 831400, China

RECRUITING

MeSH Terms

Conditions

Coronavirus Infections

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Central Study Contacts

Panpan Hao

CONTACT

86-18560086593; panda.how@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 22, 2022
• Study Start: November 1, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

CN (1)