Autoimmunity Contributes to the Severe Progression of COVID-19

NCT04967781 | Completed

• 1 other identifier: AUTO001
• Study Type: observational
• Target: 162
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (2)

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

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".

Interventions

autoimmunity BEHAVIORAL

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

Group "Severe"

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The retrospective study includes two groups of adult inpatients from two centers, Zhongnan Hospital of Wuhan University and Thunder God Mountain Hospital, Wuhan, China. All patients who were diagnosed as COVID-19 with real-time PCR (RT-PCR) assay of pharyngeal swab specimens18 confirmed results were screened, and those 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, were enrolled in our study from Jan 22, 2020 to Jun 24, 2020.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Zhongnan Hospital: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

COVID-19

Interventions

Autoimmunity

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunity; Immune System Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 20, 2021
• Study Start: March 10, 2020
• Primary Completion: May 27, 2021
• Study Completion: May 27, 2021
• Last Updated: July 20, 2021

Record last verified: 2021-07

Locations

CN (1)