Autoimmunity Contributes to the Severe Progression of COVID-19

Study Overview
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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.

Official Title
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Autoimmunity Contributes to the Severe Progression of COVID-19

Conditions
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Coronavirus Disease 2019

Intervention / Treatment
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* Behavioral: autoimmunity


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult inpatients from two centers, Zhongnan Hospital of Wuhan University and Thunder God Mountain Hospital, Wuhan, China. Experimental confirmed COVID-19 patients. 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: Minors. Experimental un-confirmed COVID-19 patients. Patients without autoimmunological detections.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Severe<br>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. | Behavioral: autoimmunity<br>* autoimmunity is characterized as self attacking from self immune system, which may involve in the severe progression of COVID-19.<br>|
| Group Non-severe<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Antinuclear autoantibodies detected by ANA+ENA test | Antinuclear antibodies are closely related with many autoimmune diseases, and involved in the pathogenesis of many kinds of viruses.ANA+ENA was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific autoantibodies were also reported if positive. | baseline | 
| Presence of Antinuclear autoantibodies detected by ANA+ENA test | Antinuclear antibodies are closely related with many autoimmune diseases, and involved in the pathogenesis of many kinds of viruses.ANA+ENA was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific autoantibodies were also reported if positive. | from the admission till the discharge of patients' hospitalization, up to 100 days. | 
| Presence of Anti-streptolysin O (ASO) | Anti-streptolysin O (ASO or ASLO) is the antibody made against streptolysin O, an immunogenic, oxygen-labile hemolytic toxin produced by most strains of group A and many strains of groups C and G streptococci.ASO was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific immune globulin types were also reported if positive. | baseline | 
| Presence of Anti-streptolysin O (ASO) | Anti-streptolysin O (ASO or ASLO) is the antibody made against streptolysin O, an immunogenic, oxygen-labile hemolytic toxin produced by most strains of group A and many strains of groups C and G streptococci.ASO was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific immune globulin types were also reported if positive. | from the admission till the discharge of patients' hospitalization, up to 100 days. | 
| Presence of Rheumatoid Factors (RF) | factors used for the diagnosis of the rheumatoid arthritis (RA).RF was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific immune globulin types were also reported if positive. | baseline | 
| Presence of Rheumatoid Factors (RF) | factors used for the diagnosis of the rheumatoid arthritis (RA).RF was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific immune globulin types were also reported if positive. | From the admission till the discharge of patients' hospitalization, up to 100 days. | 
| Presence of Anticardiolipin antibody (ACA) | Anti- cardiolipin antibody (ACA) targets against anionic phospholipids and inhibits the effect of the prothrombin-activator complex to cause arterial and/or venous thrombosis, transiently appears positive around times of acute infections and acute thrombosis.ACA was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific immune globulin types were also reported if positive. | baseline | 
| Presence of Anticardiolipin antibody (ACA) | Anti- cardiolipin antibody (ACA) targets against anionic phospholipids and inhibits the effect of the prothrombin-activator complex to cause arterial and/or venous thrombosis, transiently appears positive around times of acute infections and acute thrombosis.ACA was subjected to test from the admission till the discharge of patients' hospitalization. Both positive and negative results were reported, and detailed specific immune globulin types were also reported if positive. | From the admission till the discharge of patients' hospitalization, up to 100 days. |