Prone Positioning on Admission for Hospitalized COVID-19 Pneumonia Protocol

In hypoxic respiratory failure, placing patients in the prone position improves
ventilation to perfusion matching, alveolar recruitment, and alveolar to arterial oxygen
gradients. Specifically, in Acute Respiratory Distress Syndrome ARDS, proning intubated
patients improves overall mortality. With the emergence of SARS-COV-2, hospitals around
the world have seen a marked increase in patients with acute hypoxic respiratory failure
and ARDS. This surge in cases has prompted a search for more effective strategies to
reduce intubation and improve patient morbidity and mortality. One such strategy is that
of voluntary proning, in which awake patients are instructed to prone themselves (Early
PP With High Flow Nasal Cannula (HFNC) Versus HFNC in COVID-19 Induced Moderate to Severe
ARDS) (COVID-19 smArtphone-based Trial of Non-ICU Admission Prone Positioning (CATNAP)).

This trial proposes a voluntary proning strategy in patients admitted to the hospital,
not yet requiring mechanical ventilation. Given the clear evidence that proning improves
outcomes in ARDS, investigators hypothesize that early, voluntary self-proning may
prevent intubation and improve mortality in patients with SARS-COV-2.

Methods

This is a pilot study of up to 100 participants at UCHealth facilities.

Patients will be assessed if they can self prone safely and be assessed against inclusion
and exclusion criteria within 12 hours of admission and randomized to either prone or
supine positioning. Baseline labs will be measured and all participants will be monitored
continuously via pulse oximetry.

The Standard Supine Control Group will utilize standard oxygen (O2) device in supine
position at approximately 30-60 degrees to target peripheral capillary oxygen saturation
(SpO2) >90% and the participant or nurse will document time in non-supine position.

The Prone Experimental Group will position patient in approximately 15-degree reverse
trendelenburg and prone using pillows for comfort. The participant will be asked to
rotate to prone positioning every 2 hours while awake and encourage to sleep prone
overnight as possible with a goal of 10-12 hours daily. Patient to log all time prone.

Treatment Failure may occur and termination of Intermittent Prone Positioning will occur.
This is defined as respiratory distress or a decrease in O2 saturations <90% for more
than 2 minutes as determined by bedside nursing or per virtual pulse oximetry monitoring
notifications during the study on two consecutive occasions. The participant will be
returned to supine positioning and follow standard supine oxygenation. The participant
can be re-challenged in the prone position after the participant stabilizes for 2 hours.
The participant can also choose to stop proning and would be considered a treatment
failures.

Statistical Analysis and Sample Size In New York City the intubation rate has been
reported at 1/3 of COVID-19 positive patients admitted to the hospital. The table below
shows the sample size needed for a binomial outcome of intubation when 50% of the sample
is randomized to Prone Positioning (PP):

Alpha 0.05 0.05 0.05 0.05 Beta 0.80 0.80 0.80 0.80 Probability of intubation with PP 0.05
0.10 0.15 0.20 Probability of intubation 0.33 0.33 0.33 0.33 Proportion receiving PP 0.50
0.50 0.50 0.50 Sample size 33 39 56 97

Expecting a 13% decrease in intubations with the prone position, investigators will use a
sample size of N = 100 (50 per group) in order to have 80% power with a two-sided alpha =
0.05 for logistic regression. ANCOVA will be used to evaluate continuous, secondary
variables in order to adjust for covariates. The study is powered for the primary outcome
of intubation or no intubation. No adjustments will be made for the secondary endpoints.

The investigators and statistician will validate the data and the study will be subject
to institutional quality assurance reviews.