Investigating Development of Autoimmunity in Post-Acute COVID-19 Syndrome (PACS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05459506|
Recruitment Status : Recruiting
First Posted : July 15, 2022
Last Update Posted : February 14, 2023
|Condition or disease|
Background: As of April 10th, 2021, >1 million Canadians have contracted Coronavirus-2019-disease (COVID-19), with 398,835 infected in Ontario of whom 92% are deemed "recovered" by public health. Despite the recovery, a considerable section (10-15%) of COVID-19 survivors, irrespective of their severity (hospitalized or mild), continue to have symptoms or develop new ones. These vary in type and severity between individuals, ranging chronic fatigue, anosmia, dyspnea, diffuse pain, anxiety, cognitive impairment that is not attributed to any clinical diagnosis. This is now termed the Post-Acute COVID-19 Syndrome (PACS) or long-COVID. Much remains unknown as to what underlies this constellation of symptoms and what more severe pathologies it can lead to.
Rationale to study autoimmunity in PACS: First, diverse circulating auto antibodies and lymphopenia are associated with COVID-19 severity. Second, though the male: female sex ratio for contracting the infection and recovery rate is comparable, recent studies indicate PACS to be more prevalent in females, with increasing age and BMI. Taken together these are hallmark etiological factors and demographics underlying diverse autoimmune pathologies. Third, the lung being the primary affected organ may be the site of chronic auto inflammation itself. There is evidence of auto reactivity and detectable autoantibodies in sputa associated with autoimmune diseases with pulmonary complications (such as rheumatoid arthritis, vasculitis). Finally, there is a growing body of anecdotal evidence highlighting autoimmune diagnoses post-COVID, ranging from Guillain Barre to vasculitis to lupus, in otherwise previously healthy individuals. Our preliminary data suggests 35% of individuals post-COVID have >2 circulating autoantibodies at a high disease-modifying titre, significantly associated with health outcomes. While viruses, in general, have the innate capacity to induce autoimmunity (may not be specific to SARS-CoV2), the magnitude of PACS individuals affected warrants further investigation.
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Investigating the Relationship Between Development of Autoimmunity Due to Severe Acute Respiratory Syndrome (SARS)-Corona Virus-2 (CoV2) Infection and Long-term Health Post Recovery|
|Actual Study Start Date :||June 25, 2021|
|Estimated Primary Completion Date :||March 25, 2024|
|Estimated Study Completion Date :||March 25, 2024|
Subjects with Post Acute Sequale SARS-CoV-2 (PSAC)
Participants with PASC
Subjects with COVID but not PASC
Subjects confirmed COVID-19 positive without Post Acute Sequale SARS-CoV-2 (PASC)
- Development of auto antibodies (in blood and/or sputum) in PACS and a clinical diagnosis of an autoimmune condition over time . [ Time Frame: Baseline to 18 months ]Detection of autoantibodies in PASC and a clinical diagnosis of an autoimmune condition over time .
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05459506
|Contact: Snehal Somalwar||905-522-1155 ext email@example.com|
|St. Joseph's Healthcare Hamilton||Recruiting|
|Hamilton, Ontario, Canada, L8N 4A6|
|Contact: Snehal Somalwar 905-522-1155 ext 35594 firstname.lastname@example.org|
|Principal Investigator:||Manali Mukherjee, PhD||McMaster University|