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

Covid-19 Clinical Trial

— COVID-EP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04420312
• Other study ID #: COVID-EP
• Secondary ID: MR 4516150520
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: April 20, 2020

Study information

• Verified date: June 2020
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1024
• Est. completion date: April 20, 2020
• Est. primary completion date: April 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid-19
• Embolism
• Pulmonary Embolism

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

References & Publications (26)

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* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact of PE on COVID-19 patients	Evaluate the prevalence of Pulmonary embolism among a large population of consecutive COVID-19 patients presenting respiratory symptoms	March 1st, 2020
Secondary	Clinical and radiological characteristics	Identify the clinical, radiological or biological characteristics associated with pulmonary embolism.	April 20th,2020