IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 650
- 试验地点
- 2
- 主要终点
- Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.
研究概览
简要总结
While many COVID19 studies are focusing on the immediate biological impact of SARS-CoV2 infection, this multidisciplinary research clinic will inform the global community on its recovery phase across patient cohorts with different degrees of disease severity (asymptomatic, mild [non-hospitalized], moderate/severe [hospitalized]). The primary objectives are to: 1) evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection and 2) establish a post-COVID-19 biobank. The secondary objective is to develop a model that can predict end-organ complications using epidemiological and clinical data. To complete the objectives, the study will follow 6 patient cohorts: Patients who had previous asymptomatic or mild COVID-19 (no need for oxygen), patients who had previous moderate/severe COVID-19 (patients who had an oxygen requirement; moderate=oxygen by nasal cannula; severe=oxygen by high flow nasal cannula, non-invasive positive pressure ventilation or intubation), patients who had COVID-19 but did not develop the post-COVID-19 condition, patients who have never had COVID-19, patients who had flu-like symptoms but did not have signs or symptoms related to the infection lasting beyond 4 weeks from the date of symptom-onset, and patients with flu-like symptoms and have signs or symptoms related to the infection lasting beyond 4 weeks from the date of symptom-onset. Patients will be recruited into these cohorts using a strategy that targets the following populations: patients that were hospitalized in centers across Montreal, patients already followed at the IRCM (non-COVID-19) clinic, essential workers, and members of the same household as patients already enrolled in the IPCO clinic research protocol. The IPCO clinic research protocol is the first in the province of Quebec to systematically follow patients post-COVID-19 for short- and long-term complications including end-organ damage while building an extensive biobank that can support future mechanistic research projects.
详细描述
Primary Objectives:
- Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.
- Establish a post-COVID-19 biobank.
Secondary Objectives:
Develop a model that may predict the development of end-organ complications.
Primary Endpoint:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any gender, ≥ 18 years old
- •Current resident of Quebec
- •Speaks English or French
- •Have a personal email (to which to send reminders and questionnaire by email )
- •1 of the following criteria:
- •Individuals with at least one COVID-19 positive PCR test, serology or antibody/antigen test in the last 60 months at day of recruitment. In the absence of a positive COVID-19 test, individuals with symptoms consistent with COVID-19 while living with a person who had a confirmed positive PCR, serology or antibody/antigen COVID-19 test in the last 60 months at day of recruitment (epidemiologic link).
- •Individuals who tested negative for COVID-19 while living with a household member who tested positive for COVID-19 or had a close contact with the viral infection in the context of their work, and never had any COVID-19 related symptoms (presumed COVID negative control group).
- •Individuals who don't have any COVID-19 related symptoms actually, have never had tested positive, and have had at least one negative PCR, serology or antibody/antigen COVID-19 test (presumed COVID negative control group).
- •Individuals with an undiagnosed viral infection in the last 60 months at day of recruitment and have persistent symptoms (or not) after the participant has recovered from a viral infection.
排除标准
- •Any participant not deemed appropriate for enrollment according to the PI
- •Known pregnancy (female will not be automatically screened for pregnancy upon enrollment unless there is a possibility that they might be pregnant)
研究组 & 干预措施
Long COVID group
Patients who had previous asymptomatic or mild COVID-19 and have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis (mild=never required supplemental oxygen during the acute phase of the infection)
干预措施: Medical follow-up (Other)
Long COVID-hospitalized group
Patients who had previous moderate or severe COVID-19 and have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis (moderate=required supplemental oxygen by nasal cannula during the acute phase of the infection; severe=required supplemental oxygen by either high-flow nasal cannula, non-invasive positive pressure ventilation or intubation
干预措施: Medical follow-up (Other)
COVID-19 Recovered group
Patients who had COVID-19 but did not have signs or symptoms related to COVID-19 lasting beyond 4 weeks from the date of COVID-19 symptom-onset or diagnosis
干预措施: Medical follow-up (Other)
COVID-19 negative group
Presumed COVID negative patients (i.e., either 1) patients who never had symptoms consistent with COVID-19 AND never tested positive for COVID-19 by molecular or rapid test.)
干预措施: Medical follow-up (Other)
Recovered post-viral group
Patients with a history of acute flu-like illness who do not continue to experience persistent signs or symptoms attributable to the infection for ≥4 weeks from symptom onset.. Eligible patients may have laboratory-confirmed viral infection other than COVID-19 or a suspected viral infection without laboratory confirmation. Patients with confirmed COVID-19 are excluded
干预措施: Medical follow-up (Other)
Symptomatic post-viral group
Patients with a history of acute flu-like illness who continue to experience persistent signs or symptoms attributable to the infection for ≥4 weeks from symptom onset. Eligible patients may have laboratory-confirmed viral infection other than COVID-19 or a suspected viral infection without laboratory confirmation. Patients with confirmed COVID-19 are excluded.
干预措施: Medical follow-up (Other)
结局指标
主要结局
Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection.
时间窗: 2 years
Establish a post-COVID-19 biobank.
时间窗: 2 years
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: cardiovascular.
时间窗: 5 years
The development of any cardiovascular complication that can be plausibly related to COVID-19 will be evaluated.
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: pulmonary.
时间窗: 5 years
The development of any pulmonary complication that can be plausibly related to COVID-19 will be evaluated.
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: renal.
时间窗: 5 years
The development of any renal complication that can be plausibly related to COVID-19 will be evaluated.
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: endocrine.
时间窗: 5 years
The development of any endocrine complication that can be plausibly related to COVID-19 will be evaluated.
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: metabolic.
时间窗: 5 years
The development of any metabolic complication that can be plausibly related to COVID-19 will be evaluated.
The development of any end-organ complication that can be plausibly related to COVID-19. The following end-organ systems will be evaluated: gastro-intestinal (GI).
时间窗: 5 years
The development of any gastro-intestinal complication that can be plausibly related to COVID-19 will be evaluated.
次要结局
- The development of any end-organ complication that can plausibly be related to COVID-19. We will evaluate the following end-organ systems: neurological, cardiovascular, pulmonary, renal, endocrine and metabolic, gastro-intestinal (GI).(2 year)
- Detection of any new abnormality on echocardiogram >4 weeks after COVID-19 symptom-onset or diagnosis.(5 years)
- Detection of any new abnormality on pulmonary function testing (PFT) or any change in PFT compared to a pre- or post-COVID-19 baseline PFT(5 years)
- An increase in liver enzymes > 2X upper limit of normal that occurs post-COVID-19 and is not associated to any other process (e.g., cholestasis, drug toxicity, alcohol abuse, hepatitis A, B, C, D, E).(5 years)
- Any change in pre-COVID-19 weight, waist circumference or body mass composition(5 years)
- Any change in HgA1C, lipid profile or thyroid stimulating hormone (TSH) from pre-COVID-19 baseline that begins or persists >4 weeks after COVID-19 symptom-onset or diagnosis(5 years)
- A positive fecal calprotectin or lactoferrin measurement occurring >4 weeks after COVID-19 symptom-onset or diagnosis(5 years)
- Any significant change in renal parameters (e.g., micro-albuminuria, serum creatinine, glomerular filtration rate [GFR]) detected >4 weeks after COVID-19 symptom-onset or diagnosis(5 years)
- Any change in physical activity and/or exercise tolerance as measured by actimeter reading or 6-minute walk test (6MWT) with ambulatory oximetry(5 years)
- Any change in well-being as measured by our WHO Well-Being Questionnaire(5 years)
- Any change in functional status as measured with the Post COVID-19 Functional Status Scale (PCFS)(5 years)
- Any change in quality of life, as measured by the European Quality of Life 5 Dimensions (EuroQol-5D) tool(5 years)
- Any detection or exacerbation of post-exertional malaise (PEM)/post-exertional symptom exacerbation (PESE) using the DePaul Symptom Questionnaire - Post-exertional malaise (DSQ-PEM) short form questionnaire(5 years)
- Any detection of new (i.e., not known to be present prior to COVID-19 infection) cardiac dysautonomia using the 10-minute standing test.(5 years)
- Any detection or exacerbation of post-exertional malaise (PEM)/post-exertional symptom exacerbation (PESE) using the Questionnaire on functionnal capacity (FUNCAP27)(5 years)
研究者
Emilia Falcone, MD
Director, IRCM Post-COVID-19 Research Clinic
Institut de Recherches Cliniques de Montreal