Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID)

September 6, 2022 updated by: King Abdullah International Medical Research Center
Study hypothesis: Non-invasive positive pressure ventilation delivered by helmet will reduce 28-day all-cause mortality in patients with suspected or confirmed severe COVID-19 pneumonia and acute hypoxemic respiratory failure

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This will be a pragmatic parallel randomized control trial that will compare helmet nonivasive ventilation with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
322

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11426
        • Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Suspected or confirmed COVID-19
  • Aged ≥14 years old at the participating ICU. ICUs that use other age cut-off for adult patients will adhere to their local standard (16 or 18 years)
  • Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio <200 despite supplemental oxygen with a partial or non-rebreathing mask at a flow rate >10 L/min or above
  • Intact airway protective gag reflex
  • Able to follow instructions (e.g. squeeze hand on command, eye contact with care provider, stick out tongue on command, etc.)

Exclusion Criteria:

  • Prior intubation during this hospital admission
  • Cardiopulmonary arrest
  • Glasgow coma scale <12
  • Tracheostomy
  • Upper airway obstruction
  • Active epistaxis
  • Requirement for more than one vasopressor to maintain mean arterial pressure > 65 mm Hg
  • Pregnancy
  • Imminent intubation
  • Patients with do not intubate orders or equivalent
  • Enrolled in another trial for which co-enrolment is not approved including trials on mechanical ventilation
  • Patients already treated with helmet
  • Patients with chronic carbon dioxide retention (PaCO2 >45)
  • Previous enrolment in this trial
  • The primary cause of respiratory failure is not heart failure as judged by the treating team

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Helmet group
Patients will be allocated to helmet non-invasive ventilation
Device: Helmet non-invasive ventilation
Patients will be allocated to helmet non-invasive ventilation
NO_INTERVENTION: Control group
Patients will be allocated to standard of care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
28-day all-cause mortality
Time Frame: 28 days from randomization
all cause mortality
28 days from randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Intubation rate within 28 days
Time Frame: 28 days from randomization
endotracheal intubation
28 days from randomization
ICU mortality
Time Frame: 180 days from randomization
ICU death
180 days from randomization
Hospital mortality (censored at day 180)
Time Frame: 180 days from randomization
hospital death
180 days from randomization
Hospital length of stay
Time Frame: 180 days from randomization
length of stay in the hospital
180 days from randomization
ICU free days at day 28
Time Frame: 28 days from randomization
days not in ICU
28 days from randomization
Invasive ventilation-free days at day 28
Time Frame: 28 days from randomization
days without ventilator support
28 days from randomization
Renal replacement therapy-free days at day 28
Time Frame: 28 days from randomization
days without renal replacement therapy received
28 days from randomization
Vasopressor-free days at day 28
Time Frame: 28 days from randomization
days without vasopressor support
28 days from randomization
Safety outcome: skin pressure ulcers
Time Frame: 28 days from randomization
presence of pressure ulcers
28 days from randomization
Safety outcome: barotrauma
Time Frame: 28 days from randomization
incidence of barotrauma
28 days from randomization
Serious adverse events (including cardiovascular events and device complications)
Time Frame: 28 days from randomization
reporting of abovementioned adverse events
28 days from randomization
180-day all-cause mortality
Time Frame: 180 days from randomization
all cause mortality
180 days from randomization
Follow-up study: 180-day 5-level EQ-5D version
Time Frame: 180 days from randomization
The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
180 days from randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
King Abdullah International Medical Research Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
King Faisal Specialist Hospital & Research Center
King Abdulaziz Medical City, Riyadh, Saudi Arabia
King Fahd Hospital of the University, Al Khobar, Saudi Arabia
Aseer Central Hospital, Abha, Saudi Arabia
King Fahad Hospital, Madinah, Saudi Arabia
Al Amiri Hospital, Kuwait
King Abdulaziz University Hospital, Jeddah, Saudi Arabia
King Saud Medical City, Riyadh, Saudi Arabia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yaseen Arabi, MD, King Abdulaziz Medical City - Riyadh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 8, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 16, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC20/306/R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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