An observational study in COVID-19 Vaccines and Autoimmune Diseases, sponsored by Zhejiang Chinese Medical University. Recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Zhejiang Chinese Medical University · Observational
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Zhejiang Chinese Medical University is the lead sponsor of 22 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with ADs (≥18 years old) were recruited into the study 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. Patients were instructed to continue taking all drugs during the vaccination period, except for biotherapy that was delayed after the vaccination by physician's suggestion. The HC were healthy volunteers who did not receive immunosuppressive therapy.
Exclusion Criteria:
Healthy controls are ≥18 years old, no previous history of SARS-CoV-2 infection, and no previous history of autoimmune diseases. All the HC group were injected with 2 or 3 doses of inactivated SARS-CoV-2 vaccines.
Biological: the inactivated COVID-19 vaccines
The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were injected with the inactivated SARS-CoV-2 vaccines.
Biological: the inactivated COVID-19 vaccines
The vaccinated patients with ADs are ≥18 years old, no previous history of SARS-CoV-2 infection, and diagnosed with autoimmune diseases. All the group were not injected with the inactivated SARS-CoV-2 vaccines.
receive the doses of inactivated COVID-19 vaccines
Incidence of local and systemic adverse events
One of the primary end point was the safety of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.
Time frame: 3 years
Concentration of anti-SARS-CoV-2 spike protein
One of the primary end point was the immunogenicity of the inactivated COVID-19 vaccine in adult patients with ADs compared with controls.
Time frame: 3 years
Infection rate of COVID-19
One of the primary end point was the efficacy of the inactivated COVID-19 vaccine in adult patients with ADs.
Time frame: 3 years
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Zhejiang Chinese Medical University