Autoimmunity Contributes to the Severe Progression of COVID-19

Completed

• Conditions: Coronavirus Disease 2019
• Interventions: Behavioral: autoimmunity

• Registration Number: NCT04967781
• Lead Sponsor: Zhongnan Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2020-03-10
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Status Verified: 2021-07
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-16
• Study First Posted: 2021-07-20
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group "Severe"	autoimmunity	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".

Primary Outcome Measures

Name	Time	Method
Presence of Anti-streptolysin O (ASO)	from the admission till the discharge of patients' hospitalization, up to 100 days.	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.
Presence of Anticardiolipin antibody (ACA)	From the admission till the discharge of patients' hospitalization, up to 100 days.	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.
Presence of Antinuclear autoantibodies detected by ANA+ENA test	from the admission till the discharge of patients' hospitalization, up to 100 days.	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.
Presence of Rheumatoid Factors (RF)	From the admission till the discharge of patients' hospitalization, up to 100 days.	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.

Trial Locations

Locations (1)

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, Hubei, China