COVID-19 PandemicNCT05459506
Investigating Development of Autoimmunity in Post-Acute COVID-19 Syndrome (PACS)
An observational study of COVID-19 Pandemic, run by McMaster University at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19 Pandemic
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- 25 Jun 2021to 25 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Confirmed COVID diagnosis by PCR/sero-positive based and deemed recovered by public health. A control age-sex matched population who had symptoms (infection) and tested negative for SARS-CoV2 with a PCR test, will be recruited. A control age-sex matched population (n=20) with no infection within 4 weeks of recruitment or ever tested positive for COVID and with no known medical conditions and a non-significant smoking history (less than ten years of smoking history).
Who may be able to join
- 18 years up
- Positive PCR or antibody test
- 12 weeks post acute Covid infection with PASC
Who cannot join
- Pre-existing Auto- immune disease
- Chronic/ secondary infections
- Active Neoplasm
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Snehal Somalwar, 905-522-1155 ext. 35594, ssomalwa@stjoes.ca
About this study
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
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.
Read the detailed description
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.
- Conditions
- COVID-19 Pandemic
- Keywords
- Post Acute Sequelae, Long Covid, Rheumatology, Auto Immune
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of auto antibodies (in blood and/or sputum) in PACS and a clinical diagnosis of an autoimmune condition over time .
Detection of autoantibodies in PASC and a clinical diagnosis of an autoimmune condition over time .
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2022
- Study start25 Jun 2021
- Primary completion25 Mar 2024 (estimated)
- Study completion25 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Manali Mukherjee, PhD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05459506
- Sponsor's protocol ID
- COV-IMM001
- Status last verified
- Feb 2023
- First submitted
- 13 Jul 2022
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05459506
- Acronym / sponsor ID
- COV-IMM001
- Conditions
- COVID-19 Pandemic
- Keywords
- Post Acute Sequelae, Long Covid, Rheumatology, Auto Immune
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 25 Mar 2024 (estimated)
- Study completion
- 25 Mar 2024 (estimated)
- First posted
- 15 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Confirmed COVID diagnosis by PCR/sero-positive based and deemed recovered by public health. A control age-sex matched population who had symptoms (infection) and tested negative for SARS-CoV2 with a PCR test, will be recruited. A control age-sex matched population (n=20) with no infection within 4 weeks of recruitment or ever tested positive for COVID and with no known medical conditions and a non-significant smoking history (less than ten years of smoking history).
Key inclusion criteria (3 listed)
- 18 years up
- Positive PCR or antibody test
- 12 weeks post acute Covid infection with PASC
Key exclusion criteria (4 listed)
- Pre-existing Auto- immune disease
- Chronic/ secondary infections
- Active Neoplasm
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manali Mukherjee, PhD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Snehal Somalwar (905-522-1155 ext. 35594, ssomalwa@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.