NCT04741178

Brief Summary

The hallmark of the L phenotype is the vasoplegia, as confirmed by the rapid change in density and distribution of CT findings from the supine to the prone position. The benefit of a prone position in awake, nonintubated, spontaneously breathing Covid-19 patients has been emerging as potential tool to improve oxygenation and to prevent the access to ICU. No evidence of radiological modifications related to Aim of our study is to evaluate CT changes in terms of extension, distribution and prevalence of findings, in the supine compared with the prone position.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 3, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2021

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 10, 2021

Status Verified

February 1, 2021

Enrollment Period

10 months

First QC Date

February 3, 2021

Last Update Submit

February 7, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • CT evidence of peculiar patterns in Covid-19 pneumonia

    Identification of CT findings in order to define peculiar pattern of Covid-19 pneumonia

    March 2020-January 2021

Study Arms (1)

Patient with Covid-pneumonia

Patient with CT scan of pulmonary infiltrates suggestive of Covid pneumonia

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients were considered eligible if were with a confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL, aged between 18 and 90 years old, able to maintain both the supine and prone position on the CT scan table. Patients who were pregnant, scarcely collaborative were excluded. CT analysis was conducted by two experienced thoracic radiologists and one pulmonologist. Extension of each CT finding and presence of vessel enlargement has been scored.

You may qualify if:

  • Confirmed diagnosis of Covid-19 infection, as documented by RT-PCR nasal swab, or, confirmed by a subsequent BAL
  • Age between 18 and 90 years old
  • Ability to maintain both the supine and prone position on the CT scan table.

You may not qualify if:

  • Patients who were pregnant, scarcely collaborative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Morgagni Pierantoni Hospital

Forlì, FC, 47121, Italy

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 5, 2021

Study Start

March 20, 2020

Primary Completion

January 2, 2021

Study Completion

December 31, 2021

Last Updated

February 10, 2021

Record last verified: 2021-02

Locations