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Efficacy of the Early Prone-positioning in Hospitalized Patients With Mild Covid-19 Pneumonia

NCT05008380 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2022-11-01

No results posted yet for this study

Summary

The study aims to evaluate if the early prone-positioning in awake patients with mild Covid-19 pneumonia can reduce the need of high-flow oxygen-therapy, invasive or non-invasive ventilation and prevent the worsening of clinical conditions.

Patients will be randomized on a 1:1 ratio and stratified based on the onset of symptoms (\<10 days; \>10 days) and need of oxygen therapy (no need; need).

One branch of patients (interventional) will undergo standard of care treatment + prone-positioning cycles, the other one (controll) will undergo standard of care treatment alone.

Patients will be evaluated evaluated on the day of the enrolment, on day 1, day 3, day 7 and every 7 days until the patient dismissal or until day 28 (whichever occurs first).

Adverse events and concurrent medications will be noted as well.

The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods.

Conditions

Interventions

PROCEDURE

prone positioning

3-6 hours of prone-positioning twice a day

Sponsors & Collaborators

  • University of Milano Bicocca

    lead OTHER

Principal Investigators

  • Paolo Bonfanti · asst-monza Ospedale San Gerardo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-16
Primary Completion
2022-08-03
Completion
2022-08-03

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05008380 on ClinicalTrials.gov