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

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.

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...)