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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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COVID-19 Vaccines Autoimmune Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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healthy controls

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.

the inactivated COVID-19 vaccines

Intervention Type BIOLOGICAL

receive the doses of inactivated COVID-19 vaccines

the vaccinated patients with ADs

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.

the inactivated COVID-19 vaccines

Intervention Type BIOLOGICAL

receive the doses of inactivated COVID-19 vaccines

the unvaccinated patients with ADs

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.

No interventions assigned to this group

Interventions

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the inactivated COVID-19 vaccines

receive the doses of inactivated COVID-19 vaccines

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* ≥18 years old
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes