Pulmonary EmbolismCOVID-EPNCT04465656
Registry of the Evolution of Diagnosed and/or Hospitalized Patients for Pulmonary Embolism During the Covid-19 Pandemic
An observational study of Pulmonary Embolism, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Serology test for COVID-19
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 7 Jul 2020to 8 Sep 2022
- 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: Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)
Who may be able to join
- 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.
Who cannot join
- Subject to a measure for the protection of justice.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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].
- Conditions
- Pulmonary Embolism
- Being tested
- Serology test for COVID-19
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serology test for COVID-19Diagnostic test
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:
- ELISA test
- Rapid Diagnostic tests (only if ELISA test is positive)
| Study group | Role | What they receive |
|---|---|---|
| [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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
% 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.
PE complications :
- Chronic interstitial pathology, or
- Recurrence of PE, or
- Pulmonary hypertension, or
- Death.
Measured: 6 months after PE diagnosis
Secondary outcomes (7)
% 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.
PE complications :
- Chronic interstitial pathology, or
- Recurrence of PE, or
- Pulmonary hypertension, or
- Death.
Measured: 12 months after PE diagnosis
% 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).
PE complications :
- Chronic interstitial pathology, or
- Recurrence of PE, or
- Pulmonary hypertension, or
- Death.
Measured: 3, 6 and 12 months after PE diagnosis
% of patients diagnosed COVID - at M0 by RT-PCR on nasopharyngeal swab and diagnosed COVID + by serology 3 months after PE diagnosis
Measured: 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
Category of treatments:
- Heparin + AVK
- Heparin + DOAC
PE complication :
- Chronic interstitial pathology, or
- Recurrence of PE, or
- Pulmonary hypertension, or
- Death.
Measured: 12 months after PE diagnosis
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
Category of treatments:
- Heparin + AVK
- Heparin + DOAC
Bleeding complications: classification 1-2-3-5 according to BARC
Measured: 12 months after PE diagnosis
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
Category of treatments:
- Heparin + AVK
- Heparin + DOAC
Measured: 12 months after PE diagnosis
Effectiveness of the different category of treatments used in all patients and in the groups: duration of Heparin treatment (number of day)
Category of treatments:
- Heparin + AVK
- Heparin + DOAC
Measured: 12 months after PE diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2020
- Study start7 Jul 2020
- Primary completion8 Sep 2021
- Study completion8 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04465656
- Sponsor's protocol ID
- 2020-05-01
- Acronym
- COVID-EP
- Status last verified
- Jan 2026
- First submitted
- 30 Jun 2020
- Last updated
- 22 Jan 2026
- Results posted
- 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 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04465656
- Acronym / sponsor ID
- COVID-EP / 2020-05-01
- Conditions
- Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 8 Sep 2021 (actual)
- Study completion
- 8 Sep 2022 (actual)
- First posted
- 10 Jul 2020 (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 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].
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| [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 | – | Diagnostic Test: Serology test for COVID-19Having a microbiological diagnosis confirming the absence of COVID-19 infection (ie negative RT-PCR on nasopharyngeal swab) and absence of clinical /CT signs |
| [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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient diagnosed and / or hospitalized for PE in April 2020 (the COVID-19 pandemic peak)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Subject to a measure for the protection of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serology test for COVID-19In 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) | Diagnostic test | [PCR-COVID 19-Neg] group |
Primary outcome
% 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.
7 secondary outcomes
% 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
% 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
% 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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Embolism, run by Hospital St. Joseph, Marseille, France at 1 site in France.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 22 Jan 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
% 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). 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 22 Jan 2026.