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The aim of this trial was to investigate if a protocol for awake prone positioning reduces the rate of endotracheal intubation compared with standard care among patients with moderate to severe hypoxemic respiratory failure due to COVID-19.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a multicenter randomized clinical trial. Adult patients with confirmed COVID-19, high-flow nasal oxygen or noninvasive ventilation for respiratory support and a PaO<jats:sub>2<\/jats:sub>\/FiO<jats:sub>2<\/jats:sub>ratio \u2264\u200920\u00a0kPa were randomly assigned to a protocol targeting 16\u00a0h prone positioning per day or standard care. The primary endpoint was intubation within 30\u00a0days. Secondary endpoints included duration of awake prone positioning, 30-day mortality, ventilator-free days, hospital and intensive care unit length of stay, use of noninvasive ventilation, organ support and adverse events. The trial was terminated early due to futility.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 141 patients assessed for eligibility, 75 were randomized of whom 39 were allocated to the control group and 36 to the prone group. Within 30\u00a0days after enrollment, 13 patients (33%) were intubated in the control group versus 12 patients (33%) in the prone group (HR 1.01 (95% CI 0.46\u20132.21),<jats:italic>P<\/jats:italic>\u2009=\u20090.99). Median prone duration was 3.4\u00a0h [IQR 1.8\u20138.4] in the control group compared with 9.0\u00a0h per day [IQR 4.4\u201310.6] in the prone group (<jats:italic>P<\/jats:italic>\u2009=\u20090.014). Nine patients (23%) in the control group had pressure sores compared with two patients (6%) in the prone group (difference \u2212\u200918% (95% CI \u2212\u20092 to \u2212\u200933%);<jats:italic>P<\/jats:italic>\u2009=\u20090.032). There were no other differences in secondary outcomes between groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The implemented protocol for awake prone positioning increased duration of prone positioning, but did not reduce the rate of intubation in patients with hypoxemic respiratory failure due to COVID-19 compared to standard care.<\/jats:p><\/jats:sec><jats:sec><jats:title><jats:italic>Trial registration<\/jats:italic><\/jats:title><jats:p>ISRCTN54917435. Registered 15 June 2020 (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/doi.org\/10.1186\/ISRCTN54917435\">https:\/\/doi.org\/10.1186\/ISRCTN54917435<\/jats:ext-link>).<\/jats:p><\/jats:sec>","DOI":"10.1186\/s13054-021-03602-9","type":"journal-article","created":{"date-parts":[[2021,6,14]],"date-time":"2021-06-14T10:03:03Z","timestamp":1623664983000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":125,"title":["Awake prone positioning in patients with hypoxemic respiratory failure due to COVID-19: the PROFLO multicenter randomized clinical trial"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9518-5834","authenticated-orcid":false,"given":"Jacob","family":"Ros\u00e9n","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Erik","family":"von Oelreich","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diddi","family":"Fors","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malin","family":"Jonsson Fagerlund","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Knut","family":"Taxbro","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Skorup","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludvig","family":"Eby","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesca","family":"Campoccia Jalde","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Niclas","family":"Johansson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gustav","family":"Bergstr\u00f6m","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Frykholm","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the PROFLO Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Gradin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mustafa","family":"Ali","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrica","family":"Lennborn","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Darko","family":"Bogdanovic","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Roos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matilda","family":"Modie","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julia","family":"Giesecke","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,6,14]]},"reference":[{"key":"3602_CR1","doi-asserted-by":"publisher","first-page":"2159","DOI":"10.1056\/NEJMoa1214103","volume":"368","author":"C Gu\u00e9rin","year":"2013","unstructured":"Gu\u00e9rin C, Reignier J, Richard J-C, Beuret P, Gacouin A, Boulain T, et al. 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Ethical approval for this trial (dnr. 2020\u201302743) was provided by the Swedish Ethical Review Authority 10 June 2020. All research was performed in accordance with national guidelines and regulations. Written informed consent was obtained from all subjects.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"MJF has received travel support and lecture fees from Fisher and Paykel Healthcare, Auckland, New Zealand, however, not related to this study. DF has received travel support from Armstrong Medical, Coleraine, Great Britain, to participate in a scientific seminar, however, not related to this study. The other authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"209"}}