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

NCT05008380 | Completed

• 1 other identifier: 3772
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (1)

• Accomplishment of the end-points

  the occurence of the first of the following end-points: death, start of high flow oxygen therapy, CPAP, meccanichal ventilation, P/F \<200

  0-28 days

Secondary Outcomes (6)

• time of recovery

  0-28 days

• time of weaning from oxygen

  0-28 days

• variation of the clinical condition

  0-28 days

• mortality

  0-28 days

• number of adverse event

  0-28 days

Study Arms (2)

Standard of care + prone positioning

EXPERIMENTAL

Standard of care. Prone-positioning cycles as the following: 3-6 hours of prone-positioning twice a day.

Procedure: prone positioning

Standard of care

NO INTERVENTION

Standard of care

Interventions

prone positioning PROCEDURE

3-6 hours of prone-positioning twice a day

Standard of care + prone positioning

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• positive PCR for Sars-Cov-2 Rna on any respiratory samples within 7 days from enrollment
• imaging positive for pulmonary involvement or clinical evidence of respiratory involvement ( new onest of hypoxemia with 02 \<80mmHg or SpO2 \< 94% in air or need for oxygen therapy in oreder to mantaine SpO2 \> 93%.
• need of hospitalization

You may not qualify if:

• start of prone-positioning cycles before being enrolled in the study
• SpO2/FiO2 \<200
• need of high-flow oxygen therapy (HFNC) or need of non-invasive ventilation and/or CPAP or indications for intubation and mechanical ventilation
• relative or absolute contraindications for prone positioning (eg facial fractures, advanced pregnancy, mental status alterations, spinal instability...)

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Asst-Monza Ospedale San Gerardo

Monza, Lombardy, 20900, Italy

Location

MeSH Terms

Interventions

Prone Position

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Paolo Bonfanti

  asst-monza Ospedale San Gerardo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Infectious Diseases Department

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 17, 2021
• Study Start: August 16, 2021
• Primary Completion: August 3, 2022
• Study Completion: August 3, 2022
• Last Updated: November 1, 2022

Record last verified: 2022-10

Locations

IT (1)