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| Name | Class |
|---|---|
| King Abdulaziz Medical City, Riyadh, Saudi Arabia | UNKNOWN |
| King Fahd Hospital of the University, Al Khobar, Saudi Arabia | UNKNOWN |
| Aseer Central Hospital, Abha, Saudi Arabia | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Helmet group | Experimental | Patients will be allocated to helmet non-invasive ventilation |
|
| Control group | No Intervention | Patients will be allocated to standard of care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Helmet non-invasive ventilation | Device | Patients will be allocated to helmet non-invasive ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 28-day all-cause mortality | all cause mortality | 28 days from randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Intubation rate within 28 days | endotracheal intubation | 28 days from randomization |
| ICU mortality | ICU death | 180 days from randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yaseen Arabi, MD | King Abdulaziz Medical City - Riyadh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs | Riyadh | 11426 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42103809 | Derived | 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. | |
| 36820878 |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| King Faisal Specialist Hospital & Research Center | OTHER |
| King Fahad Hospital, Madinah, Saudi Arabia | UNKNOWN |
| Al Amiri Hospital, Kuwait | UNKNOWN |
| King Abdulaziz University | OTHER |
| King Saud Medical City | OTHER_GOV |
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| 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 |
| Derived |
| 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. |
| 36125473 | Derived | 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. |
| 35109898 | Derived | 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. |
| 34446500 | Derived | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |