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

Open-label, Controlled, Randomized Clinical Trial on the Efficacy of Early Prone-positioning in Patients With Mild Pneumonia Due to SARS-CoV-2

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Procedure: prone positioning

Detailed Description

In this prospective, unicentred, open, controlled study, patients will be randomized on a 1:1 ratio using casual permutation blocks, identifying two branches of treatment: standard of care; standard of care + prone positioning. Patients will be stratified in 4 strata based on the onset of symptoms (<10 days; >10 days) and need of oxygen therapy (no need; need).

In order to obtain statistical significance, the sample size will include 96 patients.

Patients in the SOC + prone-positioning branch will undergo cycles of prone-positioning following this scheme: 3-6 hours of prone-positioning twice a day. The actual length of the cycles will be registered during the study.

Data will be collected using a dedicated CRF, which will include recording of adverse events and concurrent medications.

Patients will be 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). If dismissal occurs before day 28, a follow-up interview will be conducted in presence or on the phone to collect the remaining data.

The analysis will be conducted according to "intention to treat" criteria; primary outcomes will be calculated using survival-based methods (Kaplan-Meier curves with log-rank test and Cox regression), while secondary outcomes will be evaluated using both survival-based methods and proportional odds model.

The occurrence of adverse events and the causes of withdrawal from the study in the two branches of treatment will be compared using chi-square test.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Monza, Lombardia, Italy, 20900
      • Asst-Monza Ospedale San Gerardo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• > 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

Exclusion Criteria:

• 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...)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of care
Experimental: Standard of care + prone positioning; Standard of care. Prone-positioning cycles as the following: 3-6 hours of prone-positioning twice a day.	Procedure: prone positioning; 3-6 hours of prone-positioning twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
number and duration of prone positioning cycles	0-28 days

Collaborators and Investigators

• Sponsor: University of Milano Bicocca
• Investigators: Principal Investigator: Paolo Bonfanti, Asst-Monza Ospedale San Gerardo

Study record dates

Study Major Dates

• Study Start (Actual): August 16, 2021
• Primary Completion (Actual): August 3, 2022
• Study Completion (Actual): August 3, 2022

Study Registration Dates

• First Submitted: August 16, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Lung Diseases; COVID-19; Pneumonia
• Other Study ID Numbers: 3772

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No