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Prevalence and Characteristics of Pulmonary Embolism on COVID-19 Patients Presenting Respiratory Symptoms (COVID-EP)

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ClinicalTrials.gov Identifier: NCT04420312
Recruitment Status : Completed
First Posted : June 9, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

Brief Summary:

Multicentric case-control study that is aims at:

  • evaluating the prevalence of pulmonary embolism among a large population of consecutive patients admitted for COVID-19 pneumonia into two large university hospitals in Paris, France: Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and Hôpital Européen Georges Pompidou (HEGP)
  • and identifying the characteristics associated with pulmonary embolism by using a nested case control study design within the patients who underwent either unenhanced computed tomograpghy (CT) or CT pulmonary angiogram (CTPA) evaluation.

Condition or disease
Pulmonary Embolism Covid-19

Detailed Description:

In December 2019, China reported the first cluster of severe acute respiratory syndrome due to a new coronavirus (SARS-CoV-2). The disease rapidly spread into a global pandemic of public health emergency worldwide leading to more than 330.000 deaths (data from May 25th, 2020). We have, to date, no demonstration on the efficacy of any drug to cure or prevent severe evolution of the disease (COVID-19). The primary target of SARS-CoV-2 is the lung with frequent occurrence of acute respiratory distress syndrome (ARDS) justifying supportive care, including invasive mechanical ventilation (IMV). The characteristics of ARDS in COVID-19 patients appeared atypical due to the dissociation between initial well-conserved lung compliance and severe hypoxemia, attributed to pulmonary vasoregulation disruption and local thrombogenesis. Strikingly high D-dimers levels, caused by both inflammation storm and coagulation activation, have been early reported in COVID-19 patients and have been associated with increased mortality. A single observational study suggests that anticoagulation is associated with a decreased mortality in severe COVID-19 patients. These reports have led to several therapeutic propositions in terms of anticoagulant therapy from worldwide scientific societies (Khider et al JMV 2020). Publications recently reported thrombotic complications in series of severe COVID-19 patients admitted in ICU, but the frequency of pulmonary embolism (PE) in larger cohort of COVID-19 patients of any severity remains uncertain.

This cohort enrolled patients in whom PE is proven by CTPA and compared them into two subgroups of controls matched for age and sex in whom PE was either excluded or non suspected:

  1. COVID-19 patients with a negative CTPA and
  2. COVID-19 patients in whom only an unhenced CT was performed.

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Study Type : Observational
Actual Enrollment : 1024 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome
Actual Study Start Date : March 1, 2020
Actual Primary Completion Date : April 20, 2020
Actual Study Completion Date : April 20, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Group 1
Enrolled the Covid-19 patients with a negative CT Pulmonary Angiogram.
Group 2
Enrolled the Covid-19 patients in whom only a CT was performed.



Primary Outcome Measures :
  1. Impact of PE on COVID-19 patients [ Time Frame: March 1st, 2020 ]
    Evaluate the prevalence of Pulmonary embolism among a large population of consecutive COVID-19 patients presenting respiratory symptoms


Secondary Outcome Measures :
  1. Clinical and radiological characteristics [ Time Frame: April 20th,2020 ]
    Identify the clinical, radiological or biological characteristics associated with pulmonary embolism.



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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:   Probability Sample
Study Population
Patients aged over 18 years, hospitalized for respiratory pathology, associated with the COVID-19; confirmed by either a RT-PCR test or a CT scan.
Criteria

Inclusion Criteria:

  • patients >18 years,
  • admitted for acute COVID-19 pneumonia and have recieved a chest CT scan during hospitalization,
  • COVID-19 diagnosis confirmed by a positive result of a RT-PCR,
  • CT findings of COVID-19 pneumonia.

Exclusion Criteria:

  • Respiratory distress syndrome explained by other cause
  • Patients who refuse to participate to the study.

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): NCT04420312


Locations
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France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Publications:
Bikdeli B, Madhavan MV, Jimenez D, Chuich T, Dreyfus I, Driggin E, Nigoghossian C, Ageno W, Madjid M, Guo Y, Tang LV, Hu Y, Giri J, Cushman M, Quéré I, Dimakakos EP, Gibson CM, Lippi G, Favaloro EJ, Fareed J, Caprini JA, Tafur AJ, Burton JR, Francese DP, Wang EY, Falanga A, McLintock C, Hunt BJ, Spyropoulos AC, Barnes GD, Eikelboom JW, Weinberg I, Schulman S, Carrier M, Piazza G, Beckman JA, Steg PG, Stone GW, Rosenkranz S, Goldhaber SZ, Parikh SA, Monreal M, Krumholz HM, Konstantinides SV, Weitz JI, Lip GYH; Global COVID-19 Thrombosis Collaborative Group, Endorsed by the ISTH, NATF, ESVM, and the IUA, Supported by the ESC Working Group on Pulmonary Circulation and Right Ventricular Function. COVID-19 and Thrombotic or Thromboembolic Disease: Implications for Prevention, Antithrombotic Therapy, and Follow-Up: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Jun 16;75(23):2950-2973. doi: 10.1016/j.jacc.2020.04.031. Epub 2020 Apr 17. Review.

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Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04420312    
Other Study ID Numbers: COVID-EP
MR 4516150520 ( Other Identifier: INDS )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
pulmonary embolism
covid-19
CT
D-Dimers
ARDS
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases