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

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.

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Key information

Conditions

Pulmonary Embolism COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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 outcomes

Clinical and radiological characteristics

Time frame: April 20th,2020

Identify the clinical, radiological or biological characteristics associated with pulmonary embolism.

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Official study title

Incidence and Characteristics of Pulmonary Embolism in COVID-19 Patients Hospitalized for Acute Respiratory Syndrome

Acronym: COVID-EP

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Jun 9, 2020
Registry last updated: Jun 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed