Microvascular Injury and Distal Thrombosis in COVID-19

Completed

• Conditions: SARS-CoV-2 Infection

• Registration Number: NCT04990505
• Lead Sponsor: Centre Hospitalier Princesse Grace

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

Study Timeline

• Study Start: 2020-02-22
• Study First Submitted: 2021-08-03
• Study First Submitted QC: 2021-08-03
• Study First Posted: 2021-08-04
• Primary Completion: 2021-10-18
• Status Verified: 2022-02
• Study Completion: 2022-02-28
• Last Update Submitted: 2022-03-08
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulmonary microvascular injury	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	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 Outcome Measures

Name	Time	Method
Prognosis evolution at 15 days	15 days after hospitalization	Determination of prognosis using categorical variables: worsening or stability vs improvement in the 15 following days, delay to the recovery of a 95% or more SpO2 in ambient air below vs above 15 days, hospitalization duration below vs above 15 days
CT abnormalities prognostic value	15 days after hospitalization	The prognostic value of the extent of CT abnormalities, a right ventricular ejection fraction below vs above 50%, a significant albumin uptake (AI/PI) above or equal to 1.7, and the presence and/or number of paradoxically hypoventilated and hypoperfused normal segments will be evaluated by Fisher's exact test and Mann Whitney U test

Trial Locations

Locations (1)

Centre Hospitalier Princesse Grace; 🇲🇨 Monaco, Monaco