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Early CPAP in COVID-19 Confirmed or Suspected Patients

NCT04390191 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-09-28

Study results available
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Summary

There is surge in COVID infected patients in New York City with a shortage of hospital beds, ICU beds and ventilators. Strategies to reduce the need for all of the above are immediately needed. Further, few interventions are targeted in COVID infected patients early in the course of their disease and especially in the community/home settings. Respiratory decompensation appears to occur later in the disease process (i.e. 7-10 days after becoming symptomatic) therefore many patients are sent home from the Emergency Room and they subsequently decompensate later at home. Some patients die at home and others are returning to the Emergency Room with hypoxemic respiratory failure. There is no treatment offered to this population of patients, i.e. COVID suspected or confirmed and with respiratory symptoms or abnormal chest x-ray at the time of presentation. Based on experience across the globe, these patients are likely to worsen at home. The study team therefore proposes a prospective, single-center, parallel group, open-label, randomized clinical trial to assess the efficacy of fixed low continuous positive airway pressure therapy (CPAP) (FDA approved and often used for treatment of sleep apnea) in COVID confirmed or suspected patients with abnormal chest x-ray or respiratory symptoms who do not require hospital admission and are discharged home from the emergency room.

Conditions

Interventions

DEVICE

Continuous Positive Airway Pressure

CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).

Sponsors & Collaborators

  • Itamar-Medical, Israel

    collaborator INDUSTRY

  • Community Surgical Supply of Toms River, Inc

    collaborator INDUSTRY

  • Philips Healthcare

    collaborator INDUSTRY

  • Icahn School of Medicine at Mount Sinai

    lead OTHER

Principal Investigators

  • Neomi Shah, MD, MPH, MS · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-07
Primary Completion
2021-02-18
Completion
2021-07-07
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04390191 on ClinicalTrials.gov