NCT05831826

Effectiveness and Safety of the Inactivated COVID-19 Vaccine in Thousands of Patients With Autoimmune Diseases in China

Multicenter Clinical and Basic Research on the Prevention and Treatment of 2019-nCoV by Integrated Traditional Chinese and Western Medicine

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (estimated)
• Sponsor: Zhejiang Chinese Medical University · Other Government
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.

Detailed description

Autoimmune diseases are disorders of the body's immune function, involving multiple organs and tissues of the whole body, and characterized by a variety of specific or non-specific autoantibodies and inflammatory factors overexpression. However, during the global COVID-19 pandemic, patients with autoimmune diseases, especially those receiving immunosuppressive therapy, face a high burden of novel coronavirus pneumonia (COVID-19) and are at higher risk for severe infection and disease progression. At present, patients with autoimmune diseases should give priority to the prevention and treatment strategy of COVID-19, among which the vaccination of novel coronavirus vaccine is the most important means to actively build herd immunity and control the epidemic of novel coronavirus pneumonia, and the combination of traditional Chinese and western medicine is an essential and effective way to prevent and treat COVID-19 infection. According to the comprehensive evaluation, the completion of vaccination and the prevention and treatment strategy of integrated traditional Chinese and western medicine have obvious advantages in improving the symptoms of infection in patients with autoimmune diseases, shortening the course of disease and controlling disease activity, and can play a positive role in the whole process of epidemic prevention and treatment. Now the investigators plan to conduct multi-center clinical and basic research to observe the preventive effect and safety of the vaccine on COVID-19, as well as the preventive effect of the combination of traditional Chinese medicine, in order to obtain high-quality evidence-based evidence and provide scientific basis for the clinical value of the drug.

Conditions

• COVID-19 Vaccines
• Autoimmune Diseases

Interventions

Type	Name	Description
BIOLOGICAL	the inactivated COVID-19 vaccines	receive the doses of inactivated COVID-19 vaccines

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2023-04-26
• Last updated: 2023-10-24

Locations

1 site across 1 country: China