Autoimmunity Contributes to the Severe Progression of COVID-19

NCT ID: NCT04967781

Last Updated: 2021-07-20

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

COMPLETED

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-10

Study Completion Date

2021-05-27

Brief Summary

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Although elderliness and chronic comorbidities such as hypertension, diabetes, cardiovascular diseases and respiratory diseases, are known risk factors for severe progression of COVID-19, it still remains puzzling on why younger patients without any comorbidity advance to severity and even more rapidly, the underlying mechanisms for severe progression of COVID-19 still needs to be elucidated. Based on current picturing of the COVID-19, similar to SARS, besides direct viral toxicity, immune-mediated attack derived from either the release of pro-inflammatory cytokine perpetual cascade, or secondary pathogen-induced autoimmunity response may also play important roles on disease progression and partly account for the multi-system injuries related with COVID-19. Virus infection has been implicated in the initiation of autoimmunity, which can attack multiple systems. With the knowledge of characteristics of SARS, high level of autoimmune activity was shown to make severe injuries to lungs or other organs, leading to poor outcome including multi-system failure9. COVID-19 may also get autoimmunity involved which is of obviously younger and female population predominance during the pathogenesis, no matter pre-existing or secondary to viral infection. Particularly strong immune response to SARS-CoV-2 infection might not be protective, but perhaps, be harmful to the host, contributing to disease severe progression.

Detailed Description

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Conditions

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Coronavirus Disease 2019

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group "Severe"

Each enrolled patient was allocated into control group "Non-severe" or case group "Severe" as per the disease severity which was defined according to the Chinese novel coronavirus pneumonia prevention and control guideline (version 6.0), "severe" and "critical" types were grouped into case group as "Severe".

autoimmunity

Intervention Type BEHAVIORAL

autoimmunity is characterized as self attacking from self immune system, which may involve in the severe progression of COVID-19.

Group "Non-severe"

Each enrolled patient was allocated into control group "Non-severe" or case group "Severe" as per the disease severity which was defined according to the Chinese novel coronavirus pneumonia prevention and control guideline (version 6.0), "mild" and "moderate" types were grouped into control group as "Non-severe".

No interventions assigned to this group

Interventions

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autoimmunity

autoimmunity is characterized as self attacking from self immune system, which may involve in the severe progression of COVID-19.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Adult inpatients from two centers, Zhongnan Hospital of Wuhan University and Thunder God Mountain Hospital, Wuhan, China.
2. Experimental confirmed COVID-19 patients.
3. Patients tested with autoimmunological detections including either ANA+ENA (Antinuclear antibody + Anti-extractable nuclear antigen antibody), Anti-cardiolipin antibody (ACA), Rheumatoid factor (RF), or Anti-streptolysin O antibody (ASO) detection.

Exclusion Criteria

1. Minors.
2. Experimental un-confirmed COVID-19 patients.
3. Patients without autoimmunological detections.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongnan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Site Status

Countries

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China

Other Identifiers

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AUTO001

Identifier Type: -

Identifier Source: org_study_id

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