Treating COVID-19 With a Bidirectional Oxygenation Valve
Clara Health

Treating COVID-19 With a Bidirectional Oxygenation Valve

Sponsored by TMC HealthCare

We have developed a simple and straightforward silicone rubber-made oral appliance that promotes positive expiratory airway pressures with the potential to enhance respiratory function while preventing and reversing atelectasis and hypoxia.

The purpose of this study is to compare the use of our bidirectional oxygenation mouthpiece with conventional oxygen support versus conventional oxygen support of any Person Under Investigation for infection by the COVID-19 virus.


Coronavirus disease 2019 (COVID-19) is a respiratory illness that can spread from person to person. The virus that causes COVID-19 is a novel coronavirus that was first identified during an investigation into an outbreak in Wuhan, China.

How is this study designed?

Study Type: Interventional (Clinical Trial) Estimated Enrollment: 15 participants Primary Purpose: Treatment Estimated Study Start Date: March 27, 2020 Estimated Study Completion Date: June 1, 2020

Who is this study for?

Inclusion Criteria:

  • Oxygen saturation <93%
  • Able to provide informed consent
  • Not currently requiring intubation
  • Receiving oxygen by face mask

Exclusion Criteria:

  • Unable or unwilling to provide informed consent, cognitive impairment
  • Rapidly decompensating status requiring urgent or emergent higher level of care

What should I expect?

This study will utilize a single center internal control study design. The objective of this study is to determine the feasibility and safety of a bidirectional oxygenation PEEP generating mouthpiece when combined with oxygen by non-rebreather face mask, compared to support by oxygen non-rebreather face mask alone.

Inpatient trial

Have questions or need help?

For general questions about COVID-19 clinical trials, please email [email protected] For study specific inquiries, submit the interest form and you'll be connected to the team.