Table 2.
Randomized controlled trials (recruiting or nonrecruiting) evaluating noninvasive respiratory support (high-flow nasal oxygen or noninvasive ventilation) in patients with COVID-19 and acute hypoxemic respiratory failure
| Trial | Identifier/Status | Country | Design | Population | Sample Size | Intervention | Primary Outcome |
|---|---|---|---|---|---|---|---|
| Comparison of HFNO, face-mask NIV and helmet NIV in COVID-19 ARDS patients (NIV COVID-19) | ClinicalTrials.gov Identifier: NCT04715243 Recruiting |
Oman | Multicenter RCT | Patients with confirmed COVID-19 in the emergency department, the ward, high dependency, or ICU with ARDS requiring NIV | 360 | Patients assigned to 1 of 3 arms: HFNO, face-mask NIV, or helmet NIV | Rate of endotracheal intubation |
| Helmet noninvasive ventilation for COVID-19 patients (Helmet-COVID) | ClinicalTrials.gov Identifier: NCT04477668 Recruiting |
Saudi Arabia | Multicenter RCT | COVID-19 with AHRF | 320 | Pragmatic parallel RCT that will compare helmet NIV with standard of care to standard of care alone in 1:1 ratio. The trial will be implemented in multiple centers | 28-d all-cause mortality |
| Early CPAP in COVID-19 patients with respiratory failure (EC-COVID-RCT) | ClinicalTrials.gov Identifier: NCT04326075 | Italy | Single-center RCT | Patients in the emergency department with confirmed or suspected COVID-19 and Spo2 < 95% with PF ratio > 200 | 900 | Early helmet CPAP vs usual care | Death or need of intubation |
| High-flow nasal oxygen vs CPAP helmet in COVID-19 pneumonia (COVIDNOCHE) | ClinicalTrials.gov Identifier: NCT04381923 Not recruiting (by August 26, 2021) |
USA | Single-center RCT | Patients with COVID-19 and refractory hypoxemia (Spo2 ≤ 92% on O2 ≥ 6 L/min by nasal cannula) | 200 | Advanced respiratory units will be assigned to use 1 of 2 default interventions (helmet CPAP vs HFNO) as the first-line treatment | Ventilator-free days within 28 d |
| High-flow nasal therapy vs conventional oxygen therapy in COVID-19 (COVID-HIGH) | ClinicalTrials.gov Identifier: NCT04655638 Recruiting |
Italy | Multicenter RCT (Europe) | Patients with confirmed COVID-19–related AHRF in any hospital ward caring for COVID-19 patients | 364 | HFNO vs conventional oxygen therapy | Proportion of patients needing escalation of treatment (ie, NIV, including CPAP, or intubation) by 28 d |
The search was performed on August 26, 2021, in ClinicalTrials.gov, using the following terms: adults (≥18 y), COVID, interventional studies, all countries, recruiting or nonrecruiting, and each of the following: noninvasive ventilation (yielded 167 studies) OR high-flow nasal oxygen (yielded 26 studies) OR continuous positive airway pressure (yielded 15 studies). Only 5 studies were RCTs as reported. Additional search on September 15, 2021, in International Clinical Trials Registry Platform and ISRCTN registry, did not yield any additional studies.