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

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: Completed
• Conditions: COVID-19; Acute Hypoxemic Respiratory Failure
• Intervention / Treatment: Device: Helmet non-invasive ventilation

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: Interventional
• Enrollment (Actual): 322
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
28-day all-cause mortality	all cause mortality	28 days from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intubation rate within 28 days	endotracheal intubation	28 days from randomization
ICU mortality	ICU death	180 days from randomization
Hospital mortality (censored at day 180)	hospital death	180 days from randomization
Hospital length of stay	length of stay in the hospital	180 days from randomization
ICU free days at day 28	days not in ICU	28 days from randomization
Invasive ventilation-free days at day 28	days without ventilator support	28 days from randomization
Renal replacement therapy-free days at day 28	days without renal replacement therapy received	28 days from randomization
Vasopressor-free days at day 28	days without vasopressor support	28 days from randomization
Safety outcome: skin pressure ulcers	presence of pressure ulcers	28 days from randomization
Safety outcome: barotrauma	incidence of barotrauma	28 days from randomization
Serious adverse events (including cardiovascular events and device complications)	reporting of abovementioned adverse events	28 days from randomization
180-day all-cause mortality	all cause mortality	180 days from randomization
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.	180 days from randomization

Collaborators and Investigators

• Sponsor: King Abdullah International Medical Research Center
• Collaborators: 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: Principal Investigator: Yaseen Arabi, MD, King Abdulaziz Medical City - Riyadh

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 8, 2021
• Primary Completion (ACTUAL): November 16, 2021
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 16, 2020
• First Posted (ACTUAL): July 20, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: helmet nonivasive ventilation
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Insufficiency
• Other Study ID 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