Skip to main content
Clinical Trials/NCT04967781
NCT04967781
Completed
Not Applicable

Autoimmunity Contributes to the Severe Progression of COVID-19

Zhongnan Hospital1 site in 1 country162 target enrollmentMarch 10, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronavirus Disease 2019
Sponsor
Zhongnan Hospital
Enrollment
162
Locations
1
Primary Endpoint
Presence of Anti-streptolysin O (ASO)
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 10, 2020
End Date
May 27, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Zhongnan Hospital
Responsible Party
Sponsor

Eligibility Criteria

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

  • Experimental un-confirmed COVID-19 patients.
  • Patients without autoimmunological detections.

Outcomes

Primary Outcomes

Presence of Anti-streptolysin O (ASO)

Time Frame: 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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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.

Study Sites (1)

Loading locations...

Similar Trials