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Institut de Recherche Cliniques de Montreal (IRCM) Post-COVID-19 (IPCO) Research Clinic (IPCO)

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: NCT04736732
Recruitment Status : Recruiting
First Posted : February 3, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
Emilia Falcone, MD, Institut de Recherches Cliniques de Montreal

Brief Summary:

Sample Size: n=570

Accrual Ceiling: n=627

Study Population: Patients age 18 to 100 years

Accrual Period: February 1, 2021 to September 30, 2022

Study Duration:

Start Date: January 1, 2021

End Date: March 1, 2025

The study duration includes 18 months to recruit patients and 24 months of total follow-up time counted from the first day of COVID-19 symptoms or date of confirmed COVID-19 diagnosis.

Study Design: This is a prospective, observational cohort study to evaluate the short- and long-term end-organ complications of COVID-19 and to establish a COVID-19 biobank.

Patient Cohorts:

  1. Patients who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection)
  2. Patients who had previous moderate or severe COVID-19 (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)
  3. 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
  4. Patients who have not had COVID-19 (i.e. patients who tested negative for COVID-19 and who never had symptoms consistent with COVID-19)

Condition or disease Intervention/treatment
Covid19 Other: Medical follow-up

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 570 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: IRCM Post-COVID-19 (IPCO) Research Clinic: a Multidisciplinary Approach to Evaluate Short and Long-term Complications of COVID-19
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : September 1, 2024
Estimated Study Completion Date : March 1, 2025


Group/Cohort Intervention/treatment
COVID-19 positive patients
  1. Patients who had previous asymptomatic or mild COVID-19 (mild=never required supplemental oxygen during the acute phase of the infection)
  2. Patients who had previous moderate or severe COVID-19 (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
  3. 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
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Name: Sample collection

COVID-19 negative patients
COVID-19 negative control group
Other: Medical follow-up
Patients will be followed for medical evaluation and for biobanking of data and biological samples.
Other Name: Sample collection




Primary Outcome Measures :
  1. Evaluate the short- and long-term end-organ complications post-COVID-19 in relation to the severity of the acute COVID-19 infection. [ Time Frame: 2 years ]
  2. Establish a post-COVID-19 biobank. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. 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). [ Time Frame: 2 year ]

Biospecimen Retention:   Samples With DNA
Saliva, nasopharyngeal swabs, blood/plasma/serum, peripheral blood mononuclear cells, urine, stool


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Adults who have had a positive diagnosis of COVID-19.
  • Adults who have tested negative for COVID-19 (control group) recruited either from the regular IRCM (Institue de Recherches Cliniques de Montréal) clinic, the household of a patient who tested positive for COVID-19 or a cohort of health care providers who were screened for COVID-19.
Criteria

Inclusion Criteria:

  • Any gender, ≥ 18 years old
  • Current resident of Quebec
  • Speaks English or French

AND

1 of the following criteria:

  • COVID-19 positive test
  • Household members of a case who has tested positive for COVID-19
  • IRCM patients with a negative COVID-19 test result
  • Health care provider with a negative COVID-19 test result

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

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): NCT04736732


Contacts
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Contact: Emilia Liana Falcone, M.D., Ph.D. 514-987-5610 Emilia.falcone@ircm.qc.ca
Contact: Amina Boubekeur, Ph.D. 514-987-5581 amina.boubekeur@ircm.qc.ca

Locations
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Canada, Quebec
Institut de Recherches Cliniques de Montreal Recruiting
Montréal, Quebec, Canada, H2W 1R7
Contact: Amina Boubekeur, Ph.D.    514-987-5581    amina.boubekeur@ircm.qc.ca   
Principal Investigator: Emilia Liana Falcone, M.D., Ph.D.         
Sponsors and Collaborators
Emilia Falcone, MD
Investigators
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Principal Investigator: Emilia Liana Falcone, M.D., Ph.D. IRCM
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Responsible Party: Emilia Falcone, MD, Director, IRCM Post-COVID-19 Research Clinic, Institut de Recherches Cliniques de Montreal
ClinicalTrials.gov Identifier: NCT04736732    
Other Study ID Numbers: 2021-1092
First Posted: February 3, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Future collaborations will be possible with data from the biobank. All data will be anonymous and a committee will evaluate requests for access to the biobank. The principal investigator is responsible for the biobank.
Access Criteria: Recognized researcher collaborating with PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Emilia Falcone, MD, Institut de Recherches Cliniques de Montreal:
Post-COVID-19 syndrome
COVID-19-related long-term complications
COVID-19 long haulers
Post-COVID-19 condition
Post-acute sequelae of COVID-19
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases