Awake Prone Position for Early Hypoxemia in COVID-19 (APPEX-19)

Boston University

Status: Completed

Conditions: COVID-19

Treatments: Other: Self-prone position recommendation; Other: Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04344587

H-40070

Details and patient eligibility

About

Prone positioning is a well studied and validated treatment for severe acute respiratory distress syndrome (ARDS), however there are no randomized studies on the use of prone positioning in the non-intubated patient. It is unknown if this intervention would be helpful in preventing further respiratory deterioration in terms of increasing supplemental oxygen requirements, endotracheal intubation, and ICU admission.

The Awake Prone Position for Early hypoxemia in COVID-19 (APPEX-19) Study is a pragmatic adaptive randomized controlled unblinded trial. APPEX-19 randomizes non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) or to usual care.

Full description

The purpose of this multi-site trial is to investigate the use of prone positioning in SARS-CoV-2 infected patients who are not intubated. The APPEX-19 study is a pragmatic adaptive randomized controlled unblinded trial. The study compares a smartphone tool that recommends non-ICU patients with COVID-19 or who are under evaluation for COVID-19 to lie in a prone position (i.e, with their stomach and chest facing down) to usual care.

Participants who are assigned to the intervention arm will receive a text message containing a link to an online website that reviews how to safely self-prone position and a recommendation to self-prone position 4 times for 1-2 hours each during the day and at night every 24 hours. Participants will also receive twice daily reminders to self-prone using the same smartphone platform.

All participants will receive twice daily Qualtrics online surveys to answer questions about which body positions they used in bed and their level of comfort and shortness of breath. Participants will receive these twice daily text messages until they are discharged, until they are transferred to the ICU, until they die, until their lung function declines, or until 14 days pass since enrollment. Thus, most participants will receive twice daily text messages for about 1 week; it is expected that almost all patients will receive twice daily text messages for no longer than 14 days. Medical charts will be reviewed daily to track routine clinical data to determine outcomes.

Boston Medical Center (BMC) / Boston University will be one of the 16 sites and the data coordinating center for this multisite trial. The unique design of the study means that if evidence accumulates that one treatment is better than the other, more participants will be chosen to receive the prone position intervention that works over time. Thus, the trial will both show what works, implement what works, and make sure that the most participants receive the treatment that works.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Assigned to or admitted to a COVID-19 ward team at a participating site (these teams only admit patients who are under investigation for COVID-19 or who have confirmed COVID-19 infection) via the emergency department (ED) within the last 24 hours
• Have access to their own functioning smartphone in the hospital room
• English or Spanish-speaking
• Ability to read simple instructions and answer simple written questions

Exclusion criteria

Baseline patient factors

• Inability to operate the hospital bed
• Inability to lie flat comfortably
• Inability to lie flat without shortness of breath
• Inability to turn over independently

Medical comorbidities

• Hemoptysis in the last 2 days
• Prior lung transplant
• Dementia

Acute issues

• Deep venous thrombosis treated for less than 2 days
• Unstable spine, femur, or pelvic fractures
• Mean arterial pressure lower than 65 mmHg
• Receiving ≥6 liters per minute of supplemental oxygen via nasal cannula, nasal pendant, or shovel mask
• Receiving supplemental oxygen via more aggressive methods (e.g. Venturi mask or non-rebreather mask)

Recent interventions

• Chest tube in place
• Tracheal surgery or sternotomy during the previous 15 days
• Serious facial trauma or facial surgery during the previous 15 days
• Cardiac pacemaker inserted in the last 2 days

Other

• Pregnancy
• Comfort measures only status
• Prisoner

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 2 patient groups

Intervention group

Experimental group

Description:

Participants in the intervention arm will receive a text message on their smartphones linking to the Qualtrics intervention website

Treatment:

Other: Self-prone position recommendation

Usual care group

Active Comparator group

Description:

Participants in the usual care arm will receive a text message on their smartphone linking to the Qualtrics usual care website

Treatment:

Other: Usual care