NCT04477668

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
322

participants targeted

Target at P50-P75 for not_applicable covid19

Timeline
Completed

Started Feb 2021

Typical duration for not_applicable covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

February 8, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 9, 2022

Status Verified

September 1, 2022

Enrollment Period

9 months

First QC Date

July 9, 2020

Last Update Submit

September 6, 2022

Conditions

COVID-19Acute Hypoxemic Respiratory Failure

Keywords

helmet nonivasive ventilation

Outcome Measures

Primary Outcomes (1)

  • 28-day all-cause mortality

    all cause mortality

    28 days from randomization

Secondary Outcomes (13)

  • Intubation rate within 28 days

    28 days from randomization

  • ICU mortality

    180 days from randomization

  • Hospital mortality (censored at day 180)

    180 days from randomization

  • Hospital length of stay

    180 days from randomization

  • ICU free days at day 28

    28 days from randomization

  • +8 more secondary outcomes

Study Arms (2)

Helmet group

EXPERIMENTAL

Patients will be allocated to helmet non-invasive ventilation

Device: Helmet non-invasive ventilation

Control group

NO INTERVENTION

Patients will be allocated to standard of care

Interventions

Helmet non-invasive ventilationDEVICE

Patients will be allocated to helmet non-invasive ventilation

Helmet group

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Riyadh, 11426, Saudi Arabia

Location

Related Publications (4)

  • 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.

    PMID: 36820878DERIVED

  • 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.

    PMID: 36125473DERIVED

  • 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.

    PMID: 35109898DERIVED

  • 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.

    PMID: 34446500DERIVED

MeSH Terms

Conditions

COVID-19Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Yaseen Arabi, MD

    King Abdulaziz Medical City - Riyadh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 20, 2020

Study Start

February 8, 2021

Primary Completion

November 16, 2021

Study Completion

June 30, 2022

Last Updated

September 9, 2022

Record last verified: 2022-09

Locations

SA(1)