Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic (COVID-EP)

• ClinicalTrials.gov Identifier: NCT04465656
• Recruitment Status: Unknown
• First Posted: July 10, 2020
• Last Update Posted: October 6, 2020
• Sponsor: Hospital St. Joseph, Marseille, France
• Information provided by (Responsible Party): Hospital St. Joseph, Marseille, France

Tracking Information

• First Submitted Date: June 30, 2020
• First Posted Date: July 10, 2020
• Last Update Posted Date: October 6, 2020
• Actual Study Start Date: July 7, 2020
• Estimated Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 9, 2020)

% of patients for each group presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 6 months after PE diagnosis. [ Time Frame: 6 months after PE diagnosis ]

PE complications :

• Chronic interstitial pathology, or
• Recurrence of PE, or
• Pulmonary hypertension, or
• Death.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 9, 2020)

• % of patients for each group and subgroup presenting the occurrence of PE complications defined by the occurrence of at least ONE of the following events up to 12 months after PE diagnosis. [ Time Frame: 12 months after PE diagnosis ]
  PE complications :

  • Chronic interstitial pathology, or
  • Recurrence of PE, or
  • Pulmonary hypertension, or
  • Death.
• % of patients in each group presenting the occurrence of each of the following events at each follow-up (3 months, 6 months and 12 months after PE diagnosis). [ Time Frame: 3, 6 and 12 months after PE diagnosis ]
  PE complications :

  • Chronic interstitial pathology, or
  • Recurrence of PE, or
  • Pulmonary hypertension, or
  • Death.
• % of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis [ Time Frame: 3 months after PE diagnosis ]
• Effectiveness of the different category of treatments used in all patients and in the groups: % of occurrence of PE complications for each categories of treatments [ Time Frame: 12 months after PE diagnosis ]
  Category of treatments:

  • Heparin + AVK
  • Heparin + DOAC

  PE complication :

  • Chronic interstitial pathology, or
  • Recurrence of PE, or
  • Pulmonary hypertension, or
  • Death.
• Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with occurrence of bleeding complications for each categories of treatments [ Time Frame: 12 months after PE diagnosis ]
  Category of treatments:

  • Heparin + AVK
  • Heparin + DOAC

  Bleeding complications: classification 1-2-3-5 according to BARC
• Effectiveness of the different category of treatments used in all patients and in the groups: % of patients with no occurrence of complications for each categories of treatments [ Time Frame: 12 months after PE diagnosis ]
  Category of treatments:

  • Heparin + AVK
  • Heparin + DOAC
• Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day) [ Time Frame: 12 months after PE diagnosis ]
  Category of treatments:

  • Heparin + AVK
  • Heparin + DOAC

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic
• Official Title: Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic: Retrospective and Prospective Multicentric Study.
• Brief Summary: The purpose of the study COVID-EP is to classify all the complications occurring after the diagnosis of pulmonary embolism in patients tested initially COVID-19 positive and negative by RT-PCR (on nasopharyngeal sample) during the peak of the pandemic in France (April 2020). The patients will be followed for 1 year in order to provide clinical and paraclinical data not yet published in the literature. In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed. The collected complications will then be compared between each of the 3 following groups: [PCR-COVID 19-Neg & Sero-COVID 19-Neg] versus [PCR-COVID 19-Neg & Sero-COVID 19-Pos] versus [PCR-COVID 19-Pos].
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)
• Condition: Pulmonary Embolism

Intervention

Diagnostic Test: Serology test for COVID-19

In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts:

1. ELISA test
2. Rapid Diagnostic tests (only if ELISA test is positive)

Study Groups/Cohorts

• [PCR-COVID 19-Pos] group
  Having a microbiological diagnosis confirming COVID-19 infection (ie positive RT-PCR on nasopharyngeal swab) and/or clinical/CT signs
• [PCR-COVID 19-Neg] group
  Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs
  Intervention: Diagnostic Test: Serology test for COVID-19
• [PCR-COVID 19-Neg & Sero-COVID 19-Pos] group
  • Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs
  • Having been tested positive in a serological test for COVID-19 at M3
• [PCR-COVID 19-Neg & Sero-COVID 19-Neg] group
  • Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs
  • Having been tested negative in a serological test for COVID-19 at M3

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 9, 2020): 250
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: April 30, 2021
• Estimated Primary Completion Date: October 31, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Aged ≥ 18 years,
• Diagnosed for pulmonary embolism between April 1st and April 30th, 2020; (treated by ambulatory care or hospitalized),
• Having given free and informed written consent,
• Being affiliated with or benefiting from a social security scheme.

Exclusion Criteria:

• Subject to a measure for the protection of justice.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04465656
• Other Study ID Numbers: 2020-05-01
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hospital St. Joseph, Marseille, France
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital St. Joseph, Marseille, France
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Hospital St. Joseph, Marseille, France
• Verification Date: October 2020