AirFLO2 with COVID-19 - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if the study device, called AirFLO2, can improve oxygen and decrease the amount of effort it takes to breathe in patients with COVID-19.

The AirFLO2 is a small, portable facemask that can be carried around and self-applied to stop coughing episodes, improve oxygen levels, and decrease effort to breathe.

Estamos haciendo este estudio para conocer si el dispositivo de estudio, llamado AirFLO2, puede mejorar el oxígeno y disminuir el esfuerzo que los pacientes con COVID-19 tienen que hacer para poder respirar.

El dispositivo de estudio AirFLO2 es una mascarilla facial pequeña y portátil que puede ser usada en cualquier momento para detener episodios de tos, mejorar los niveles de oxígeno, y disminuir el esfuerzo para respirar.

Who Can Participate in the Study?

Adults who:
-Have a COVID-19 diagnosis and are in the hospital
-Are able to consent and hold a mask to their face

Adultos que:
-Tienen diagnóstico de COVID-19 y están hospitalizados
-Tienen la capacidad de dar consentimiento y de usar la mascarilla facial

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
-Complete questionnaires
-Allow the study team to review your medical record
-Be randomly assigned (a fair 50/50 chance) to Group 1 or Group 2
--Group 1 will get the study device AirFLO2
--Group 2 will get the standard treatment care

Si usted decide participar en el estudio, usted:
-Completará cuestionarios
-Le permitirá a los investigadores de este estudio revisar su expediente médico
-Será aleatoriamente asignado (una probabilidad igual de 50/50) al Grupo 1 o al Grupo 2
--Grupo 1 recibirá el dispositivo de estudio AirFLO2
--Grupo 2 recibirá el tratamiento convencional

Study Details

Full Title
AirFLO2 Treatment for Hypoxia and/or Tachypnea in Patients with COVID-19
Principal Investigator
Pulmonologist
Protocol Number
IRB: PRO00105246
NCT: NCT04649775
Phase
Phase N/A
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
Contact the Duke Recruitment Innovation Center
MyResearchPartners@duke.edu
or
919-681-5698