Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial.
Identifieur interne : 000864 ( Main/Corpus ); précédent : 000863; suivant : 000865Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial.
Auteurs : Samuel M. Brown ; Ithan Peltan ; Naresh Kumar ; Lindsay Leither ; Brandon J. Webb ; Nathan Starr ; Colin K. Grissom ; Whitney R. Buckel ; Rajendu Srivastava ; Allison M. Butler ; Danielle Groat ; Benjamin Haaland ; Jian Ying ; Estelle Harris ; Stacy Johnson ; Robert Paine ; Tom GreeneSource :
- Annals of the American Thoracic Society [ 2325-6621 ] ; 2020.
Abstract
RATIONALE
The COVID-19 pandemic struck an immunologically naïve, globally interconnected population. In the face of a new infectious agent causing acute respiratory failure for which there were no known effective therapies, rapid, often pragmatic trials were necessary to evaluate potential treatments, frequently starting with medications that are already marketed for other indications. Early in the pandemic, hydroxychloroquine and azithromycin were two such candidates.
OBJECTIVE
Assess the relative efficacy of hydroxychloroquine and azithromycin among hospitalized patients with COVID-19.
METHODS
We performed a randomized clinical trial of hydroxychloroquine vs. azithromycin among hospitalized patients with COVID-19. Treatment was 5 days of study medication. The primary endpoint was the COVID Ordinal Outcomes scale at day 14. Secondary endpoints included hospital-, ICU-, and ventilator-free days at day 28. The trial was stopped early after enrollment of 85 patients when a separate clinical trial concluded that a clinically important effect of hydroxychloroquine over placebo was definitively excluded. Comparisons were made a priori using a proportional odds model from a Bayesian perspective.
RESULTS
We enrolled 85 patients at 13 hospitals over 11 weeks. Adherence to study medication was high. The estimated odds ratio for less favorable status on the ordinal scale for hydroxychloroquine vs. azithromycin from the primary analysis was 1.07, with a 95% credible interval from 0.63 to 1.83 with a posterior probability of 60% that hydroxychloroquine was worse than azithryomycin. Secondary outcomes displayed a similar, slight preference for azithromycin over hydroxychloroquine. QTc prolongation was rare and did not differ between groups. The twenty safety outcomes were similar between arms with the possible exception of post-randomization onset acute kidney injury, which was more common with hydroxychloroquine (15% vs. 0%). Patients in the hydroxychloroquine arm received remdesivir more often than in the azithromycin arm (19% vs. 2%). There was no apparent association between remdesivir use and acute kidney injury.
CONCLUSIONS
While early termination limits the precision of our results, we found no suggestion of substantial efficacy for hydroxychloroquine over azithromycin. Acute kidney injury may be more common with hydroxychloroquine than azithromycin, although this may be due to the play of chance. Differential use of remdesivir may have biased our results in favor of hydroxychloroquine. Our results are consistent with conclusions from other trials that hydroxychloroquine cannot be recommended for inpatients with COVID-19; azithromycin may merit additional investigation.
CLINICAL TRIAL REGISTRATION
This trial was prospectively registered (NCT04329832) before enrollment of the first patient.
DOI: 10.1513/AnnalsATS.202008-940OC
PubMed: 33166179
PubMed Central: PMC8009003
Links to Exploration step
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial.</title><author><name sortKey="Brown, Samuel M" sort="Brown, Samuel M" uniqKey="Brown S" first="Samuel M" last="Brown">Samuel M. Brown</name><affiliation><nlm:affiliation>Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States; samuel.brown@imail.org.</nlm:affiliation></affiliation></author><author><name sortKey="Peltan, Ithan" sort="Peltan, Ithan" uniqKey="Peltan I" first="Ithan" last="Peltan">Ithan Peltan</name><affiliation><nlm:affiliation>Intermountain Medical Center, 98078, Division of Pulmonary & Critical Care Medicine, Murray, Utah, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Kumar, Naresh" sort="Kumar, Naresh" uniqKey="Kumar N" first="Naresh" last="Kumar">Naresh Kumar</name><affiliation><nlm:affiliation>Intermountain Medical Center, Office of Research, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Leither, Lindsay" sort="Leither, Lindsay" uniqKey="Leither L" first="Lindsay" last="Leither">Lindsay Leither</name><affiliation><nlm:affiliation>Intermountain Medical Center, 98078, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Webb, Brandon J" sort="Webb, Brandon J" uniqKey="Webb B" first="Brandon J" last="Webb">Brandon J. Webb</name><affiliation><nlm:affiliation>Intermountain Medical Center, Division of Clinical Epidemiology and Infectious Diseases, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Starr, Nathan" sort="Starr, Nathan" uniqKey="Starr N" first="Nathan" last="Starr">Nathan Starr</name><affiliation><nlm:affiliation>Intermountain Medical Center, Internal Medicine, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Grissom, Colin K" sort="Grissom, Colin K" uniqKey="Grissom C" first="Colin K" last="Grissom">Colin K. Grissom</name><affiliation><nlm:affiliation>Intermountain Medical Center, Critical Care Medicine, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Buckel, Whitney R" sort="Buckel, Whitney R" uniqKey="Buckel W" first="Whitney R" last="Buckel">Whitney R. Buckel</name><affiliation><nlm:affiliation>Intermountain Medical Center, Pharmacy, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Srivastava, Rajendu" sort="Srivastava, Rajendu" uniqKey="Srivastava R" first="Rajendu" last="Srivastava">Rajendu Srivastava</name><affiliation><nlm:affiliation>Intermountain Medical Center, 98078, Office of Research, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Butler, Allison M" sort="Butler, Allison M" uniqKey="Butler A" first="Allison M" last="Butler">Allison M. Butler</name><affiliation><nlm:affiliation>Intermountain Healthcare, Statistical Data Center, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Groat, Danielle" sort="Groat, Danielle" uniqKey="Groat D" first="Danielle" last="Groat">Danielle Groat</name><affiliation><nlm:affiliation>Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Haaland, Benjamin" sort="Haaland, Benjamin" uniqKey="Haaland B" first="Benjamin" last="Haaland">Benjamin Haaland</name><affiliation><nlm:affiliation>University of Utah, Biostatistics, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Ying, Jian" sort="Ying, Jian" uniqKey="Ying J" first="Jian" last="Ying">Jian Ying</name><affiliation><nlm:affiliation>University of Utah, Biostatistics, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Harris, Estelle" sort="Harris, Estelle" uniqKey="Harris E" first="Estelle" last="Harris">Estelle Harris</name><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Johnson, Stacy" sort="Johnson, Stacy" uniqKey="Johnson S" first="Stacy" last="Johnson">Stacy Johnson</name><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Internal Medicine, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Paine, Robert" sort="Paine, Robert" uniqKey="Paine R" first="Robert" last="Paine">Robert Paine</name><affiliation><nlm:affiliation>University of Utah, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Greene, Tom" sort="Greene, Tom" uniqKey="Greene T" first="Tom" last="Greene">Tom Greene</name><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Study Design and Biostatistics Center and Division of Epidemiology, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:33166179</idno><idno type="pmid">33166179</idno><idno type="doi">10.1513/AnnalsATS.202008-940OC</idno><idno type="pmc">PMC8009003</idno><idno type="wicri:Area/Main/Corpus">000864</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000864</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial.</title><author><name sortKey="Brown, Samuel M" sort="Brown, Samuel M" uniqKey="Brown S" first="Samuel M" last="Brown">Samuel M. Brown</name><affiliation><nlm:affiliation>Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States; samuel.brown@imail.org.</nlm:affiliation></affiliation></author><author><name sortKey="Peltan, Ithan" sort="Peltan, Ithan" uniqKey="Peltan I" first="Ithan" last="Peltan">Ithan Peltan</name><affiliation><nlm:affiliation>Intermountain Medical Center, 98078, Division of Pulmonary & Critical Care Medicine, Murray, Utah, United States.</nlm:affiliation></affiliation><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Kumar, Naresh" sort="Kumar, Naresh" uniqKey="Kumar N" first="Naresh" last="Kumar">Naresh Kumar</name><affiliation><nlm:affiliation>Intermountain Medical Center, Office of Research, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Leither, Lindsay" sort="Leither, Lindsay" uniqKey="Leither L" first="Lindsay" last="Leither">Lindsay Leither</name><affiliation><nlm:affiliation>Intermountain Medical Center, 98078, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Webb, Brandon J" sort="Webb, Brandon J" uniqKey="Webb B" first="Brandon J" last="Webb">Brandon J. Webb</name><affiliation><nlm:affiliation>Intermountain Medical Center, Division of Clinical Epidemiology and Infectious Diseases, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Starr, Nathan" sort="Starr, Nathan" uniqKey="Starr N" first="Nathan" last="Starr">Nathan Starr</name><affiliation><nlm:affiliation>Intermountain Medical Center, Internal Medicine, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Grissom, Colin K" sort="Grissom, Colin K" uniqKey="Grissom C" first="Colin K" last="Grissom">Colin K. Grissom</name><affiliation><nlm:affiliation>Intermountain Medical Center, Critical Care Medicine, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Buckel, Whitney R" sort="Buckel, Whitney R" uniqKey="Buckel W" first="Whitney R" last="Buckel">Whitney R. Buckel</name><affiliation><nlm:affiliation>Intermountain Medical Center, Pharmacy, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Srivastava, Rajendu" sort="Srivastava, Rajendu" uniqKey="Srivastava R" first="Rajendu" last="Srivastava">Rajendu Srivastava</name><affiliation><nlm:affiliation>Intermountain Medical Center, 98078, Office of Research, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Butler, Allison M" sort="Butler, Allison M" uniqKey="Butler A" first="Allison M" last="Butler">Allison M. Butler</name><affiliation><nlm:affiliation>Intermountain Healthcare, Statistical Data Center, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Groat, Danielle" sort="Groat, Danielle" uniqKey="Groat D" first="Danielle" last="Groat">Danielle Groat</name><affiliation><nlm:affiliation>Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Haaland, Benjamin" sort="Haaland, Benjamin" uniqKey="Haaland B" first="Benjamin" last="Haaland">Benjamin Haaland</name><affiliation><nlm:affiliation>University of Utah, Biostatistics, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Ying, Jian" sort="Ying, Jian" uniqKey="Ying J" first="Jian" last="Ying">Jian Ying</name><affiliation><nlm:affiliation>University of Utah, Biostatistics, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Harris, Estelle" sort="Harris, Estelle" uniqKey="Harris E" first="Estelle" last="Harris">Estelle Harris</name><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Johnson, Stacy" sort="Johnson, Stacy" uniqKey="Johnson S" first="Stacy" last="Johnson">Stacy Johnson</name><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Internal Medicine, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Paine, Robert" sort="Paine, Robert" uniqKey="Paine R" first="Robert" last="Paine">Robert Paine</name><affiliation><nlm:affiliation>University of Utah, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author><author><name sortKey="Greene, Tom" sort="Greene, Tom" uniqKey="Greene T" first="Tom" last="Greene">Tom Greene</name><affiliation><nlm:affiliation>University of Utah School of Medicine, 12348, Study Design and Biostatistics Center and Division of Epidemiology, Salt Lake City, Utah, United States.</nlm:affiliation></affiliation></author></analytic><series><title level="j">Annals of the American Thoracic Society</title><idno type="eISSN">2325-6621</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>RATIONALE</b></p><p>The COVID-19 pandemic struck an immunologically naïve, globally interconnected population. In the face of a new infectious agent causing acute respiratory failure for which there were no known effective therapies, rapid, often pragmatic trials were necessary to evaluate potential treatments, frequently starting with medications that are already marketed for other indications. Early in the pandemic, hydroxychloroquine and azithromycin were two such candidates.</p></div><div type="abstract" xml:lang="en"><p><b>OBJECTIVE</b></p><p>Assess the relative efficacy of hydroxychloroquine and azithromycin among hospitalized patients with COVID-19.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>We performed a randomized clinical trial of hydroxychloroquine vs. azithromycin among hospitalized patients with COVID-19. Treatment was 5 days of study medication. The primary endpoint was the COVID Ordinal Outcomes scale at day 14. Secondary endpoints included hospital-, ICU-, and ventilator-free days at day 28. The trial was stopped early after enrollment of 85 patients when a separate clinical trial concluded that a clinically important effect of hydroxychloroquine over placebo was definitively excluded. Comparisons were made a priori using a proportional odds model from a Bayesian perspective.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>We enrolled 85 patients at 13 hospitals over 11 weeks. Adherence to study medication was high. The estimated odds ratio for less favorable status on the ordinal scale for hydroxychloroquine vs. azithromycin from the primary analysis was 1.07, with a 95% credible interval from 0.63 to 1.83 with a posterior probability of 60% that hydroxychloroquine was worse than azithryomycin. Secondary outcomes displayed a similar, slight preference for azithromycin over hydroxychloroquine. QTc prolongation was rare and did not differ between groups. The twenty safety outcomes were similar between arms with the possible exception of post-randomization onset acute kidney injury, which was more common with hydroxychloroquine (15% vs. 0%). Patients in the hydroxychloroquine arm received remdesivir more often than in the azithromycin arm (19% vs. 2%). There was no apparent association between remdesivir use and acute kidney injury.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>While early termination limits the precision of our results, we found no suggestion of substantial efficacy for hydroxychloroquine over azithromycin. Acute kidney injury may be more common with hydroxychloroquine than azithromycin, although this may be due to the play of chance. Differential use of remdesivir may have biased our results in favor of hydroxychloroquine. Our results are consistent with conclusions from other trials that hydroxychloroquine cannot be recommended for inpatients with COVID-19; azithromycin may merit additional investigation.</p></div><div type="abstract" xml:lang="en"><p><b>CLINICAL TRIAL REGISTRATION</b></p><p>This trial was prospectively registered (NCT04329832) before enrollment of the first patient.</p></div></front></TEI><pubmed><MedlineCitation Status="Publisher" Owner="NLM"><PMID Version="1">33166179</PMID><DateRevised><Year>2021</Year><Month>04</Month><Day>07</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">2325-6621</ISSN><JournalIssue CitedMedium="Internet"><PubDate><Year>2020</Year><Month>Nov</Month><Day>09</Day></PubDate></JournalIssue><Title>Annals of the American Thoracic Society</Title><ISOAbbreviation>Ann Am Thorac Soc</ISOAbbreviation></Journal><ArticleTitle>Hydroxychloroquine vs. Azithromycin for Hospitalized Patients with COVID-19 (HAHPS): Results of a Randomized, Active Comparator Trial.</ArticleTitle><ELocationID EIdType="doi" ValidYN="Y">10.1513/AnnalsATS.202008-940OC</ELocationID><Abstract><AbstractText Label="RATIONALE" NlmCategory="BACKGROUND">The COVID-19 pandemic struck an immunologically naïve, globally interconnected population. In the face of a new infectious agent causing acute respiratory failure for which there were no known effective therapies, rapid, often pragmatic trials were necessary to evaluate potential treatments, frequently starting with medications that are already marketed for other indications. Early in the pandemic, hydroxychloroquine and azithromycin were two such candidates.</AbstractText><AbstractText Label="OBJECTIVE" NlmCategory="OBJECTIVE">Assess the relative efficacy of hydroxychloroquine and azithromycin among hospitalized patients with COVID-19.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">We performed a randomized clinical trial of hydroxychloroquine vs. azithromycin among hospitalized patients with COVID-19. Treatment was 5 days of study medication. The primary endpoint was the COVID Ordinal Outcomes scale at day 14. Secondary endpoints included hospital-, ICU-, and ventilator-free days at day 28. The trial was stopped early after enrollment of 85 patients when a separate clinical trial concluded that a clinically important effect of hydroxychloroquine over placebo was definitively excluded. Comparisons were made a priori using a proportional odds model from a Bayesian perspective.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">We enrolled 85 patients at 13 hospitals over 11 weeks. Adherence to study medication was high. The estimated odds ratio for less favorable status on the ordinal scale for hydroxychloroquine vs. azithromycin from the primary analysis was 1.07, with a 95% credible interval from 0.63 to 1.83 with a posterior probability of 60% that hydroxychloroquine was worse than azithryomycin. Secondary outcomes displayed a similar, slight preference for azithromycin over hydroxychloroquine. QTc prolongation was rare and did not differ between groups. The twenty safety outcomes were similar between arms with the possible exception of post-randomization onset acute kidney injury, which was more common with hydroxychloroquine (15% vs. 0%). Patients in the hydroxychloroquine arm received remdesivir more often than in the azithromycin arm (19% vs. 2%). There was no apparent association between remdesivir use and acute kidney injury.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">While early termination limits the precision of our results, we found no suggestion of substantial efficacy for hydroxychloroquine over azithromycin. Acute kidney injury may be more common with hydroxychloroquine than azithromycin, although this may be due to the play of chance. Differential use of remdesivir may have biased our results in favor of hydroxychloroquine. Our results are consistent with conclusions from other trials that hydroxychloroquine cannot be recommended for inpatients with COVID-19; azithromycin may merit additional investigation.</AbstractText><AbstractText Label="CLINICAL TRIAL REGISTRATION" NlmCategory="BACKGROUND">This trial was prospectively registered (NCT04329832) before enrollment of the first patient.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Brown</LastName><ForeName>Samuel M</ForeName><Initials>SM</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-1206-6261</Identifier><AffiliationInfo><Affiliation>Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States; samuel.brown@imail.org.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Peltan</LastName><ForeName>Ithan</ForeName><Initials>I</Initials><Identifier Source="ORCID">http://orcid.org/0000-0003-1730-234X</Identifier><AffiliationInfo><Affiliation>Intermountain Medical Center, 98078, Division of Pulmonary & Critical Care Medicine, Murray, Utah, United States.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Kumar</LastName><ForeName>Naresh</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Intermountain Medical Center, Office of Research, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Leither</LastName><ForeName>Lindsay</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Intermountain Medical Center, 98078, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Webb</LastName><ForeName>Brandon J</ForeName><Initials>BJ</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-1799-3315</Identifier><AffiliationInfo><Affiliation>Intermountain Medical Center, Division of Clinical Epidemiology and Infectious Diseases, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Starr</LastName><ForeName>Nathan</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>Intermountain Medical Center, Internal Medicine, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Grissom</LastName><ForeName>Colin K</ForeName><Initials>CK</Initials><AffiliationInfo><Affiliation>Intermountain Medical Center, Critical Care Medicine, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Buckel</LastName><ForeName>Whitney R</ForeName><Initials>WR</Initials><Identifier Source="ORCID">http://orcid.org/0000-0001-9505-2572</Identifier><AffiliationInfo><Affiliation>Intermountain Medical Center, Pharmacy, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Srivastava</LastName><ForeName>Rajendu</ForeName><Initials>R</Initials><AffiliationInfo><Affiliation>Intermountain Medical Center, 98078, Office of Research, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Butler</LastName><ForeName>Allison M</ForeName><Initials>AM</Initials><AffiliationInfo><Affiliation>Intermountain Healthcare, Statistical Data Center, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Groat</LastName><ForeName>Danielle</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Intermountain Medical Center, Center for Humanizing Critical Care, Murray, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Haaland</LastName><ForeName>Benjamin</ForeName><Initials>B</Initials><AffiliationInfo><Affiliation>University of Utah, Biostatistics, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ying</LastName><ForeName>Jian</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University of Utah, Biostatistics, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Harris</LastName><ForeName>Estelle</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>University of Utah School of Medicine, 12348, Division of Pulmonary & Critical Care Medicine, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Johnson</LastName><ForeName>Stacy</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>University of Utah School of Medicine, 12348, Internal Medicine, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Paine</LastName><ForeName>Robert</ForeName><Initials>R</Initials><Suffix>3rd</Suffix><AffiliationInfo><Affiliation>University of Utah, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Greene</LastName><ForeName>Tom</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>University of Utah School of Medicine, 12348, Study Design and Biostatistics Center and Division of Epidemiology, Salt Lake City, Utah, United States.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04329832</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>U01 HL123018</GrantID><Acronym>HL</Acronym><Agency>NHLBI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>UL1 RR025764</GrantID><Acronym>RR</Acronym><Agency>NCRR NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>U01 HL123009</GrantID><Acronym>HL</Acronym><Agency>NHLBI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>UL1 TR002538</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>K23 GM129661</GrantID><Acronym>GM</Acronym><Agency>NIGMS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>UL1 TR000105</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>U01 HL143505</GrantID><Acronym>HL</Acronym><Agency>NHLBI NIH HHS</Agency><Country>United States</Country></Grant><Grant><GrantID>UL1 TR001067</GrantID><Acronym>TR</Acronym><Agency>NCATS NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>11</Month><Day>09</Day></ArticleDate></Article><MedlineJournalInfo><Country>United States</Country><MedlineTA>Ann Am Thorac Soc</MedlineTA><NlmUniqueID>101600811</NlmUniqueID><ISSNLinking>2325-6621</ISSNLinking></MedlineJournalInfo><CitationSubset>IM</CitationSubset></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>11</Month><Day>9</Day><Hour>17</Hour><Minute>10</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>11</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>11</Month><Day>10</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>aheadofprint</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">33166179</ArticleId><ArticleId IdType="doi">10.1513/AnnalsATS.202008-940OC</ArticleId><ArticleId 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