Autoimmunity Contributes to the Severe Progression of COVID-19

Sponsor
Zhongnan Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04967781
Collaborator
(none)
162
1
14.6
11.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: autoimmunity

Study Design

Study Type:
Observational
Actual Enrollment :
162 participants
Observational Model:
Case-Control
Time Perspective:
Retrospective
Official Title:
Autoimmunity Contributes to the Severe Progression of COVID-19
Actual Study Start Date :
Mar 10, 2020
Actual Primary Completion Date :
May 27, 2021
Actual Study Completion Date :
May 27, 2021

Arms and Interventions

Arm Intervention/Treatment
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".

Behavioral: autoimmunity
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".

Outcome Measures

Primary Outcome Measures

  1. Presence of Antinuclear autoantibodies detected by ANA+ENA test [baseline]

    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.

  2. 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.

  3. Presence of Anti-streptolysin O (ASO) [baseline]

    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.

  4. 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.

  5. Presence of Rheumatoid Factors (RF) [baseline]

    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.

  6. 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.

  7. Presence of Anticardiolipin antibody (ACA) [baseline]

    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.

  8. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongnan Hospital of Wuhan University Wuhan Hubei China 430000

Sponsors and Collaborators

  • Zhongnan Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhongnan Hospital
ClinicalTrials.gov Identifier:
NCT04967781
Other Study ID Numbers:
  • AUTO001
First Posted:
Jul 20, 2021
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2021