Clinical trial NCT04990505: Microvascular Injury and Distal Thrombosis in COVID-19
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS-CoV-2 Infection
Keywords: lung thrombosis
pulmonary embolism
lung scintigraphy
alveolar albumin uptake
Lead sponsor: Centre Hospitalier Princesse Grace
Sponsor class: OTHER
First posted: 2021-08-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the COVID-19 Unit for SARS-CoV-2 pneumonia with oxygen requirement

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

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.

Primary outcomes:
measure: Scintigraphic pattern of peripheral lung thrombosis
timeFrame: During hospitalization
measure: Pulmonary microvascular injury
timeFrame: During hospitalization
Secondary outcomes:
measure: Prognosis evolution at 15 days
timeFrame: 15 days after hospitalization
measure: CT abnormalities prognostic value
timeFrame: 15 days after hospitalization
Other outcomes:
Locations:
city: Monaco
country: Monaco
facility: Centre Hospitalier Princesse Grace
Study officials:
References:
citation: Maincent C, Perrin C, Chironi G, Baque-Juston M, Berthier F, Paulmier B, Hugonnet F, Dittlot C, Farhad RL, Renvoise J, Serrano B, Nataf V, Mocquot F, Keita-Perse O, Claessens YE, Faraggi M. Microvascular injuries, secondary edema, and inconsistencies in lung vascularization between affected and nonaffected pulmonary segments of non-critically ill hospitalized COVID-19 patients presenting with clinical deterioration. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221096040. doi: 10.1177/17534666221096040.