Clinical trial NCT04967781: Autoimmunity Contributes to the Severe Progression of COVID-19
Official title: Autoimmunity Contributes to the Severe Progression of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Disease 2019
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2021-07-20
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Presence of Antinuclear autoantibodies detected by ANA+ENA test
timeFrame: baseline
measure: Presence of Antinuclear autoantibodies detected by ANA+ENA test
timeFrame: from the admission till the discharge of patients' hospitalization, up to 100 days.
measure: Presence of Anti-streptolysin O (ASO)
timeFrame: baseline
measure: Presence of Anti-streptolysin O (ASO)
timeFrame: from the admission till the discharge of patients' hospitalization, up to 100 days.
measure: Presence of Rheumatoid Factors (RF)
timeFrame: baseline
measure: Presence of Rheumatoid Factors (RF)
timeFrame: From the admission till the discharge of patients' hospitalization, up to 100 days.
measure: Presence of Anticardiolipin antibody (ACA)
timeFrame: baseline
measure: Presence of Anticardiolipin antibody (ACA)
timeFrame: From the admission till the discharge of patients' hospitalization, up to 100 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
References: