Early CPAP in COVID-19 Confirmed or Suspected Patients

NCT04390191 | Terminated Results DMC FDA Device

• 1 other identifier: GCO 20-0900
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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

COVID-19; COVID; Coronavirus

Keywords

Continuous Positive Airway Pressure; COVID-19; Coronavirus; Positive airway pressure; Hospital admission; Non-invasive ventilation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Met the Efficacy Endpoint

  Number of participants who met the efficacy endpoint within 14 days. The efficacy endpoint is meeting any of the following: All-cause mortality within 14 days of randomization, hospital admission (including ED visit) within 14 days of randomization, oxygen saturation less than 90 during the 72-hour observation period from randomization, absolute reduction in oxygen saturation of more than 4% during the 72-hour observation period from randomization. If a participant meets any of the events noted in the composite endpoint, it is counted as a worse outcome. The composite endpoints were selected based on available covid-related information at the time of the study design. This study was conducted to determine measures that alleviated hospital burden, allowing patients to be managed at home. Oxygen-related endpoints measure improvement in a home setting and contribute to a higher number of events in the composite outcomes, to provide enough power to measure efficacy in a small trial.

  14 days

Secondary Outcomes (8)

• Number of Participants Admitted to the ICU

  14 days from randomization

• Time to Intubation and Mechanical Ventilation

  14 days from randomization

• Number of Deaths at 14 Day and 28 Day Mortality

  14-28 days from randomization

• Conversion of COVID Household Members in CPAP vs Control

  14 days from randomization

• Change in Clinical COPD Questionnaire (CCQ)

  baseline and 14 days from randomization

Study Arms (2)

Continuous Positive Airway Pressure (CPAP)

EXPERIMENTAL

Patients will be given CPAP at fixed pressure of 8-10 cm water pressure for 72 hours continuously

Device: Continuous Positive Airway Pressure

Control

NO INTERVENTION

Patients in this arm will be not be given any intervention and will be monitored for 72 hours continuously, and then daily for a total of 14 days.

Interventions

Continuous Positive Airway Pressure DEVICE

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).

Also known as: CPAP

Continuous Positive Airway Pressure (CPAP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \> 18 years old
• Patients living alone or with more than one room at home
• COVID confirmed or suspected
• To be discharged home or already discharged
• One or more of these: fever (\>38oC), sore throat, myalgia or flu-like illness
• One or more of the following: abnormal chest x-ray, new onset cough, mild hypoxemia (saturation between 92-96%), abnormal lung exam, chest tightness or shortness of breath

You may not qualify if:

• Unable to self quarantine for 72 hours if in the CPAP arm
• Preexisting pulmonary diseases such as advanced COPD, advanced parenchymal lung disease, history of pneumothorax etc.
• Claustrophobic and unable to tolerate CPAP mask
• Evidence of hypercapnia
• Recent heart of lung surgery within 3 months
• Individuals without access to smart phones or wireless connection or internet access
• Prior history of aspiration
• Speech or swallowing impairment (risk of aspiration)
• History of stroke with significant neurologic deficit
• Advanced symptomatic heart failure
• Unable to provide informed consent
• household with young children and child care responsibilities
• household with high-risk individuals (defined as over 60 or with comorbidities (e.g. heart disease, diabetes, pulmonary))

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Itamar-Medical, Israel: collaborator
• Community Surgical Supply of Toms River, Inc: collaborator
• Philips Healthcare: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Neomi Shah
• Organization: Icahn School of Medicine at Mount Sinai

neomi.shah@mssm.edu

212-241-6286

Study Officials

• Neomi Shah, MD, MPH, MS

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Model Details: This is a prospective, single-center, parallel group, open-label, randomized clinical trial, where the study team will investigate the efficacy of continuous positive airway pressure therapy (CPAP) in COVID suspected or confirmed patients who are sent home from the emergency room with mild pneumonia or respiratory illness but who do not require hospital admission. The study team proposes a randomized controlled trial of CPAP (n=100) vs. control (n=100) in COVID-19 suspected or confirmed patients with pneumonia or respiratory illness.

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 15, 2020
• Study Start: May 7, 2020
• Primary Completion: February 18, 2021
• Study Completion: July 7, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)