NCT05008380

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: University of Milano Bicocca · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• COVID-19 Pneumonia

Interventions

Type	Name	Description
PROCEDURE	prone positioning	3-6 hours of prone-positioning twice a day

Timeline

• Start date: 2021-08-16
• Primary completion: 2022-08-03
• Completion: 2022-08-03
• First posted: 2021-08-17
• Last updated: 2022-11-01

Locations

1 site across 1 country: Italy