Recruiting

Observational Study

Sponsor:

McMaster University

Code:

NCT05459506

Conditions

COVID-19 Pandemic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

The coronavirus pandemic has severely affected healthcare systems and changed life as everyone know it, globally. Apart from the acute phase disease complications, it is now apparent that a significant proportion (15%) of patients who recover continue experiencing symptoms such as chronic fatigue, shortness of breath, joint pains, cognitive impairment ("brain fog"), etc. for several months, if not for life. This syndrome has been labeled as "long-COVID" or Post-Acute COVID-19 Syndrome (PACS) and can happen to anyone whether you're young, old, healthy, or have a chronic illness. One can get it even if the COVID-19 symptoms were mild. There is no confirmed cause as to why this happens. However, there is data to support that inappropriate activation of the immune system by the virus may play a role. While our immune system is programmed to protect us against foreign invaders (such as viruses), in this case, it is directed against elements of our own. The net result is autoimmunity, where the immune system produces autoantibodies that cause damage to the body. This may lead to the development of chronic and serious diseases like lupus, rheumatoid arthritis, vasculitis, scleroderma, and others.The aim of our study is to understand the exact impairment of the immune system, why these patients develop autoantibodies, characterize their impact on the clinical symptoms of PACS, and, potentially, identify ways to modify this. The study's impact is significant since it is projected that 150000 Canadians will experience (or are already experiencing) this syndrome.

Conditions

COVID-19 Pandemic

Study ID

NCT05459506

Start date

Jun 25, 2021

Status verified date

Feb, 2023

Completion date

Mar 25, 2024

Anticipated

Primary completion date

Mar 25, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 18 years up
  • Positive PCR or antibody test
  • 12 weeks post acute Covid infection with PASC

Exclusion Criteria:

  • Pre-existing Auto- immune disease
  • Chronic/ secondary infections
  • Active Neoplasm
  • Pregnancy

Study Design

Enrollment

120 participants

Anticipated

Interventions and Outcome Measures

Arms

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)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4A6

Contacts

More Information

Sponsor

McMaster University

Last update posted

Feb 14, 2023

Last verified

Feb, 2023

Keywords

  • Post Acute Sequelae
  • Long Covid
  • Rheumatology
  • Auto Immune

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2023-02-14.