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Clinical Trials/NCT04990505
NCT04990505
Completed
Not Applicable

Microvascular Injury With Secondary Edema, and Distal Peripheral Vascular Thrombosis Contribution to Clinical Deterioration of Non-critically Ill Patients Hospitalized for SARS-CoV-2 Pneumonia Without Evidence of Pulmonary Embolism: a Preliminary Prospective Observational Study

Centre Hospitalier Princesse Grace1 site in 1 country25 target enrollmentFebruary 22, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
SARS-CoV-2 Infection
Sponsor
Centre Hospitalier Princesse Grace
Enrollment
25
Locations
1
Primary Endpoint
Pulmonary microvascular injury
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Investigators aimed to better understand the pathophysiology of SARS-CoV-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement

Detailed Description

Investigators plan to consecutively enrol 25 patients without clinical or biological evidence for superinfection, without left ventricular dysfunction and for whom a pulmonary embolism was discarded by computed tomography pulmonary angiography. Investigators will investigate lung ventilation and perfusion (LVP) by LVP scintigraphy, and, 24 hours later, left and right ventricular function by 99mTc-labelled albumin gated-blood-pool scintigraphy with late (60 mn) tomographic albumin images on the lungs to evaluate lung albumin retention that could indicate microvascular injuries with secondary edema

Registry
clinicaltrials.gov
Start Date
February 22, 2020
End Date
February 28, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Non-critically ill patients hospitalized in the COVID-19 Unit of the Centre Hospitalier Princesse Grace of Monaco
  • Presenting with a sudden clinical deterioration defined by a respiratory rate impairment and/or a rise of oxygen flow to reach a peripheral capillary oxygen saturation (SpO2) of more than 95% during at least 48 hours
  • a diagnosis of pulmonary embolism was discarded by CT pulmonary angiography
  • no clinical or biological (procalcitonin levels) evidence of lung superinfection
  • without clinical evidence for LV dysfunction

Exclusion Criteria

  • Non confirmed COVID-19 pneumonia according to the WHO guidance by a positive result of RT-PCR assay of nasal and pharyngeal swabs,
  • Patients without peripheral pulmonary ground-glass opacities or air-space consolidation on their chest CT scan at admission and common laboratory findings including lymphocytopenia, eosinopenia, significantly elevated markers of organ inflammation such as fibrinogen and C-reactive protein.
  • Patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they required critical care unit, or in case of a pregnancy.

Outcomes

Primary Outcomes

Pulmonary microvascular injury

Time Frame: During hospitalization

Determination of the number of patients/pulmonary segments with evidence for microvascular injury on the basis of a lung 99mTc albumin retention, calculated as albumin uptake normalized by the macro-aggregates perfusion uptake

Scintigraphic pattern of peripheral lung thrombosis

Time Frame: During hospitalization

Determination of the number of patients/pulmonary segments with scintigraphic pattern of peripheral lung thrombosis on the basis of a mismatch between normal ventilation and abnormal perfusion

Secondary Outcomes

  • Prognosis evolution at 15 days(15 days after hospitalization)
  • CT abnormalities prognostic value(15 days after hospitalization)

Study Sites (1)

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