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

According to the comprehensive evaluation, the completion of vaccination and theprevention and treatment strategy of integrated traditional Chinese and western medicinehave obvious advantages in improving the symptoms of infection in patients withautoimmune 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 observethe preventive effect and safety of the vaccine on COVID-19, as well as the preventiveeffect of the combination of traditional Chinese medicine, in order to obtainhigh-quality evidence-based evidence and provide scientific basis for the clinical valueof 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.

Recruiting
COVID-19 Vaccines
Autoimmune Diseases

Biological: the inactivated COVID-19 vaccines

receive the doses of inactivated COVID-19 vaccines

Eligibility Criteria

Inclusion Criteria:

- ≥18 years old

- The ADs group were diagnosed with autoimmune diseases according to the following
inclusion criteria: rheumatoid arthritis (RA) / American College of Rheumatology
(ACR)/European League Against Rheumatism (EULAR) 2010 classification criteria;
ankylosing spondylitis (AS) / the 1984 modified New York criteria; systemic lupus
erythematosus (SLE) / 2019 EULAR/ACR classification criteria; Sjögren's Syndrome
(SS) / 2016 ACR/EULAR Classification Criteria; systemic vasculitis / Chapel Hill
Consensus Conference definitions; idiopathic inflammatory myositis (IIM) / 2017
EULAR/ACR classification criteria; psoriatic arthritis (PsA) / 2006 Classification
Criteria for PsA; systemic sclerosis (SSc) / 2013 ACR/EULAR collaborative
initiative; polymyalgia rheumatica (PMR) / 2012 provisional classification criteria.

- The HC group were volunteers who did not have history of autoimmune diseases and did
not receive immunosuppressive therapy.

Exclusion Criteria:

- history of COVID-19 infection

- history of vaccination allergy

- history of mental disabilities

- pregnancy

- unwillingness to sign informed consent.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 85 Years
Countries
China
Locations

The Affiliated Hospital of Zhejiang Chinese Medicine University
Hangzhou, Zhejiang, China

Investigator: Wumeng Jin
jwm8956@126.com

Contacts

Wumeng Jin
+8615824198956
jwm8956@126.com

Wumeng Jin, Principal Investigator
Zhejiang Chinese Medical University

Zhejiang Chinese Medical University
NCT Number
MeSH Terms
COVID-19
Autoimmune Diseases