Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic (COVID-EP)
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ClinicalTrials.gov Identifier: NCT04465656 |
Recruitment Status : Unknown
Verified October 2020 by Hospital St. Joseph, Marseille, France.
Recruitment status was: Recruiting
First Posted : July 10, 2020
Last Update Posted : October 6, 2020
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Condition or disease | Intervention/treatment |
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Pulmonary Embolism | Diagnostic Test: Serology test for COVID-19 |
Study Type : | Observational |
Estimated Enrollment : | 250 participants |
Observational Model: | Cohort |
Time Perspective: | Retrospective |
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. |
Actual Study Start Date : | July 7, 2020 |
Estimated Primary Completion Date : | October 31, 2020 |
Estimated Study Completion Date : | April 30, 2021 |

Group/Cohort | Intervention/treatment |
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[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
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[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
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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:
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[PCR-COVID 19-Neg & Sero-COVID 19-Pos] group
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[PCR-COVID 19-Neg & Sero-COVID 19-Neg] group
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- % 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.
- % 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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.

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): NCT04465656
Contact: Cécile Bielmann | 0033 (0)4 88 73 10 70 | cbielmann@hopital-saint-joseph.fr | |
Contact: Rahmia AHAMADA | 0033 (0)4 91 80 71 12 | rahamada@hopital-saint-joseph.fr |
France | |
Hôpital Saint Joseph Marseille | Recruiting |
Marseille, France | |
Contact: Roger Rosario, Dr |
Responsible Party: | Hospital St. Joseph, Marseille, France |
ClinicalTrials.gov Identifier: | NCT04465656 |
Other Study ID Numbers: |
2020-05-01 |
First Posted: | July 10, 2020 Key Record Dates |
Last Update Posted: | October 6, 2020 |
Last Verified: | October 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Pulmonary Embolism Embolism Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections |