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COVID-19Helmet-COVIDNCT04477668

Helmet Non-Invasive Ventilation for COVID-19 Patients

A study testing Helmet non-invasive ventilation in people with COVID-19 and Acute Hypoxemic Respiratory Failure, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 14 years and older
Conditions the study is for
COVID-19, Acute Hypoxemic Respiratory Failure
What is being tested?
Helmet non-invasive ventilation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
322 participants
Where
1 siteSaudi Arabia
Study dates
8 Feb 2021to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.)

Who cannot join

  • Prior intubation during this hospital admission
  • Cardiopulmonary arrest
  • Glasgow coma scale <12
  • Tracheostomy
  • Upper airway obstruction
  • Active epistaxis
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Saudi Arabia1 site

  • Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs

    Riyadh, 11426

Other trials in Saudi Arabia

About this study

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

Read the 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.

Being tested
Helmet non-invasive ventilation
Keywords
helmet nonivasive ventilation
Medical subject headings
COVID-19, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Helmet non-invasive ventilationDevice

    Patients will be allocated to helmet non-invasive ventilation

Study groups in NCT04477668
Study groupRoleWhat they receive
Helmet groupExperimentalPatients will be allocated to helmet non-invasive ventilation
Receives: Device: Helmet non-invasive ventilation
Control groupNo interventionPatients will be allocated to standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 28-day all-cause mortality

    all cause mortality

    Measured: 28 days from randomization

Secondary outcomes (13)

  1. Intubation rate within 28 days

    endotracheal intubation

    Measured: 28 days from randomization

  2. ICU mortality

    ICU death

    Measured: 180 days from randomization

  3. Hospital mortality (censored at day 180)

    hospital death

    Measured: 180 days from randomization

  4. Hospital length of stay

    length of stay in the hospital

    Measured: 180 days from randomization

  5. ICU free days at day 28

    days not in ICU

    Measured: 28 days from randomization

  6. Invasive ventilation-free days at day 28

    days without ventilator support

    Measured: 28 days from randomization

  7. Renal replacement therapy-free days at day 28

    days without renal replacement therapy received

    Measured: 28 days from randomization

  8. Vasopressor-free days at day 28

    days without vasopressor support

    Measured: 28 days from randomization

  9. Safety outcome: skin pressure ulcers

    presence of pressure ulcers

    Measured: 28 days from randomization

  10. Safety outcome: barotrauma

    incidence of barotrauma

    Measured: 28 days from randomization

  11. Serious adverse events (including cardiovascular events and device complications)

    reporting of abovementioned adverse events

    Measured: 28 days from randomization

  12. 180-day all-cause mortality

    all cause mortality

    Measured: 180 days from randomization

  13. Follow-up study: 180-day 5-level EQ-5D version

    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.

    Measured: 180 days from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2020
  2. Study start8 Feb 2021
  3. Primary completion16 Nov 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
322 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04477668
Sponsor's protocol ID
RC20/306/R
Acronym
Helmet-COVID
Status last verified
Sep 2022
First submitted
9 Jul 2020
Last updated
9 Sep 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Amer M, Al-Dorzi HM, Aldekhyl S, Al Qahtani S, Lewis K, Abdukahil SA, Altamimi AM, Alanazi SA, AlObaidi M, Alswaidan LM, Al Harbi MK, Al Qasim E, Kharaba A, Albrahim T, Alshahrani MS, Al-Fares AA, Al Bshabshe A, Mady A, Al Duhailib Z, Algethamy H, Jose J, Al Mutairi M, Al Zumai O, Al Haji H, Alaqeily A, Al Aseri Z, Al-Omari A, Al-Dawood A, Tlayjeh H, Arabi YM. Dexmedetomidine for sedation during noninvasive ventilation in COVID-19 patients from the Helmet-COVID randomized clinical trial post-hoc analysis. Sci Rep. 2026 May 9;16(1):21228. doi: 10.1038/s41598-026-49301-9.

    PubMed 42103809

  • Arabi YM, Al-Dorzi HM, Aldekhyl S, Al Qahtani S, Abdukahil SA, Al Qasim E, Al Harbi MK, Kharaba A, Albrahim T, Alshahrani MS, Al-Fares AA, Al Bshabshe A, Mady A, Al Duhailib Z, Algethamy H, Jose J, Al Mutairi M, Al Zumai O, Al Haji H, Alaqeily A, Al Wehaibi W, Al Aseri Z, Al-Omari A, Tlayjeh H, Al-Dawood A; Saudi Critical Care Trials Group. Long-term outcomes of patients with COVID-19 treated with helmet noninvasive ventilation or usual respiratory support: follow-up study of the Helmet-COVID randomized clinical trial. Intensive Care Med. 2023 Mar;49(3):302-312. doi: 10.1007/s00134-023-06981-5. Epub 2023 Feb 23.

    PubMed 36820878

  • Arabi YM, Aldekhyl S, Al Qahtani S, Al-Dorzi HM, Abdukahil SA, Al Harbi MK, Al Qasim E, Kharaba A, Albrahim T, Alshahrani MS, Al-Fares AA, Al Bshabshe A, Mady A, Al Duhailib Z, Algethamy H, Jose J, Al Mutairi M, Al Zumai O, Al Haji H, Alaqeily A, Al Aseri Z, Al-Omari A, Al-Dawood A, Tlayjeh H; Saudi Critical Care Trials Group. Effect of Helmet Noninvasive Ventilation vs Usual Respiratory Support on Mortality Among Patients With Acute Hypoxemic Respiratory Failure Due to COVID-19: The HELMET-COVID Randomized Clinical Trial. JAMA. 2022 Sep 20;328(11):1063-1072. doi: 10.1001/jama.2022.15599.

    PubMed 36125473

  • Arabi Y, Aldekhyl S, Al Qahtani S, Al-Dorzi HM, Abdukahil SA, Jose J, Al Harbi MK, Al Haji H, Al Mutairi M, Al Zumai O, Al Qasim E, Al Wehaibi W, Alshahrani M, Albrahim T, Mady A, Al Bshabshe A, Al Aseri Z, Al Duhailib Z, Kharaba A, Alqahtani R, Algethamy H, Alfaris O, Alnafel O, Al-Fares AA, Tlayjeh H. Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID): statistical analysis plan for a randomized controlled trial. Trials. 2022 Feb 2;23(1):105. doi: 10.1186/s13063-021-05988-x.

    PubMed 35109898

  • Arabi YM, Tlayjeh H, Aldekhyl S, Al-Dorzi HM, Abdukahil SA, Al Harbi MK, Al Haji H, Al Mutairi M, Al Zumai O, Al Qasim E, Al Wehaibi W, Al Qahtani S, Al-Hameed F, Chalabi J, Alshahrani M, Albrahim T, Alharthy A, Mady A, Bin Eshaq A, Al Bshabshe AA, Al Aseri Z, Al Duhailib Z, Kharaba A, Alqahtani R, Al Ghamdi A, Altalag A, Alghamdi K, Almaani M, Algethamy H, Al Aqeily A, Al Baseet F, Al Samannoudi H, Al Obaidi M, Ismaiel YT, Al-Fares AA. Helmet Non-Invasive Ventilation for COVID-19 Patients (Helmet-COVID): study protocol for a multicentre randomised controlled trial. BMJ Open. 2021 Aug 26;11(8):e052169. doi: 10.1136/bmjopen-2021-052169.

    PubMed 34446500

Questions about this trial

What is this clinical trial studying?

A study testing Helmet non-invasive ventilation in people with COVID-19 and Acute Hypoxemic Respiratory Failure, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

28-day all-cause mortality (time frame: 28 days from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04477668, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2022.

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