Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.
Identifieur interne : 000908 ( Main/Exploration ); précédent : 000907; suivant : 000909Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.
Auteurs : Joseph Miller [États-Unis] ; Charles Bruen [États-Unis] ; Michael Schnaus [États-Unis] ; Jeffrey Zhang [États-Unis] ; Sadia Ali [États-Unis] ; April Lind [États-Unis] ; Zachary Stoecker [États-Unis] ; Kenneth Stauderman [États-Unis] ; Sudarshan Hebbar [États-Unis]Source :
- Critical care (London, England) [ 1466-609X ] ; 2020.
Descripteurs français
- KwdFr :
- Adulte d'âge moyen (MeSH), Canaux calciques activés par la libération de calcium (antagonistes et inhibiteurs), Femelle (MeSH), Humains (MeSH), Indice de gravité de la maladie (MeSH), Infections à coronavirus (thérapie), Mâle (MeSH), Norme de soins (MeSH), Pandémies (MeSH), Pneumopathie virale (thérapie), Résultat thérapeutique (MeSH), Soins de réanimation (méthodes), Sujet âgé (MeSH).
- MESH :
- antagonistes et inhibiteurs : Canaux calciques activés par la libération de calcium.
- méthodes : Soins de réanimation.
- thérapie : Infections à coronavirus, Pneumopathie virale.
- Adulte d'âge moyen, Femelle, Humains, Indice de gravité de la maladie, Mâle, Norme de soins, Pandémies, Résultat thérapeutique, Sujet âgé.
English descriptors
- KwdEn :
- Aged (MeSH), Calcium Release Activated Calcium Channels (antagonists & inhibitors), Coronavirus Infections (therapy), Critical Care (methods), Female (MeSH), Humans (MeSH), Male (MeSH), Middle Aged (MeSH), Pandemics (MeSH), Pneumonia, Viral (therapy), Severity of Illness Index (MeSH), Standard of Care (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , antagonists & inhibitors : Calcium Release Activated Calcium Channels.
- methods : Critical Care.
- therapy : Coronavirus Infections, Pneumonia, Viral.
- Aged, Female, Humans, Male, Middle Aged, Pandemics, Severity of Illness Index, Standard of Care, Treatment Outcome.
Abstract
BACKGROUND
Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia.
METHODS
A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study.
RESULTS
In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO
CONCLUSIONS
Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.
DOI: 10.1186/s13054-020-03220-x
PubMed: 32795330
PubMed Central: PMC7427272
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.</title><author><name sortKey="Miller, Joseph" sort="Miller, Joseph" uniqKey="Miller J" first="Joseph" last="Miller">Joseph Miller</name><affiliation wicri:level="2"><nlm:affiliation>Henry Ford Hospital System, Detroit, MI, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry Ford Hospital System, Detroit, MI</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Bruen, Charles" sort="Bruen, Charles" uniqKey="Bruen C" first="Charles" last="Bruen">Charles Bruen</name><affiliation wicri:level="2"><nlm:affiliation>Regions Hospital, Health Partners, St. Paul, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Regions Hospital, Health Partners, St. Paul, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Schnaus, Michael" sort="Schnaus, Michael" uniqKey="Schnaus M" first="Michael" last="Schnaus">Michael Schnaus</name><affiliation wicri:level="2"><nlm:affiliation>Regions Hospital, Health Partners, St. Paul, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Regions Hospital, Health Partners, St. Paul, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Zhang, Jeffrey" sort="Zhang, Jeffrey" uniqKey="Zhang J" first="Jeffrey" last="Zhang">Jeffrey Zhang</name><affiliation wicri:level="2"><nlm:affiliation>Princeton Pharmatech, Princeton, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Princeton Pharmatech, Princeton, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Ali, Sadia" sort="Ali, Sadia" uniqKey="Ali S" first="Sadia" last="Ali">Sadia Ali</name><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Lind, April" sort="Lind, April" uniqKey="Lind A" first="April" last="Lind">April Lind</name><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Stoecker, Zachary" sort="Stoecker, Zachary" uniqKey="Stoecker Z" first="Zachary" last="Stoecker">Zachary Stoecker</name><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Stauderman, Kenneth" sort="Stauderman, Kenneth" uniqKey="Stauderman K" first="Kenneth" last="Stauderman">Kenneth Stauderman</name><affiliation wicri:level="1"><nlm:affiliation>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037</wicri:regionArea><wicri:noRegion>92037</wicri:noRegion></affiliation></author><author><name sortKey="Hebbar, Sudarshan" sort="Hebbar, Sudarshan" uniqKey="Hebbar S" first="Sudarshan" last="Hebbar">Sudarshan Hebbar</name><affiliation wicri:level="1"><nlm:affiliation>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037</wicri:regionArea><wicri:noRegion>92037</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2020">2020</date><idno type="RBID">pubmed:32795330</idno><idno type="pmid">32795330</idno><idno type="doi">10.1186/s13054-020-03220-x</idno><idno type="pmc">PMC7427272</idno><idno type="wicri:Area/Main/Corpus">000648</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000648</idno><idno type="wicri:Area/Main/Curation">000648</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000648</idno><idno type="wicri:Area/Main/Exploration">000648</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.</title><author><name sortKey="Miller, Joseph" sort="Miller, Joseph" uniqKey="Miller J" first="Joseph" last="Miller">Joseph Miller</name><affiliation wicri:level="2"><nlm:affiliation>Henry Ford Hospital System, Detroit, MI, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Henry Ford Hospital System, Detroit, MI</wicri:regionArea><placeName><region type="state">Michigan</region></placeName></affiliation></author><author><name sortKey="Bruen, Charles" sort="Bruen, Charles" uniqKey="Bruen C" first="Charles" last="Bruen">Charles Bruen</name><affiliation wicri:level="2"><nlm:affiliation>Regions Hospital, Health Partners, St. Paul, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Regions Hospital, Health Partners, St. Paul, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Schnaus, Michael" sort="Schnaus, Michael" uniqKey="Schnaus M" first="Michael" last="Schnaus">Michael Schnaus</name><affiliation wicri:level="2"><nlm:affiliation>Regions Hospital, Health Partners, St. Paul, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Regions Hospital, Health Partners, St. Paul, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation><affiliation wicri:level="2"><nlm:affiliation>University of Minnesota, Minneapolis, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>University of Minnesota, Minneapolis, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Zhang, Jeffrey" sort="Zhang, Jeffrey" uniqKey="Zhang J" first="Jeffrey" last="Zhang">Jeffrey Zhang</name><affiliation wicri:level="2"><nlm:affiliation>Princeton Pharmatech, Princeton, NJ, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Princeton Pharmatech, Princeton, NJ</wicri:regionArea><placeName><region type="state">New Jersey</region></placeName></affiliation></author><author><name sortKey="Ali, Sadia" sort="Ali, Sadia" uniqKey="Ali S" first="Sadia" last="Ali">Sadia Ali</name><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Lind, April" sort="Lind, April" uniqKey="Lind A" first="April" last="Lind">April Lind</name><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Stoecker, Zachary" sort="Stoecker, Zachary" uniqKey="Stoecker Z" first="Zachary" last="Stoecker">Zachary Stoecker</name><affiliation wicri:level="2"><nlm:affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>Methodist Hospital, Park Nicollet, St. Louis Park, MN</wicri:regionArea><placeName><region type="state">Minnesota</region></placeName></affiliation></author><author><name sortKey="Stauderman, Kenneth" sort="Stauderman, Kenneth" uniqKey="Stauderman K" first="Kenneth" last="Stauderman">Kenneth Stauderman</name><affiliation wicri:level="1"><nlm:affiliation>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037</wicri:regionArea><wicri:noRegion>92037</wicri:noRegion></affiliation></author><author><name sortKey="Hebbar, Sudarshan" sort="Hebbar, Sudarshan" uniqKey="Hebbar S" first="Sudarshan" last="Hebbar">Sudarshan Hebbar</name><affiliation wicri:level="1"><nlm:affiliation>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com.</nlm:affiliation><country xml:lang="fr">États-Unis</country><wicri:regionArea>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037</wicri:regionArea><wicri:noRegion>92037</wicri:noRegion></affiliation></author></analytic><series><title level="j">Critical care (London, England)</title><idno type="eISSN">1466-609X</idno><imprint><date when="2020" type="published">2020</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged (MeSH)</term><term>Calcium Release Activated Calcium Channels (antagonists & inhibitors)</term><term>Coronavirus Infections (therapy)</term><term>Critical Care (methods)</term><term>Female (MeSH)</term><term>Humans (MeSH)</term><term>Male (MeSH)</term><term>Middle Aged (MeSH)</term><term>Pandemics (MeSH)</term><term>Pneumonia, Viral (therapy)</term><term>Severity of Illness Index (MeSH)</term><term>Standard of Care (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adulte d'âge moyen (MeSH)</term><term>Canaux calciques activés par la libération de calcium (antagonistes et inhibiteurs)</term><term>Femelle (MeSH)</term><term>Humains (MeSH)</term><term>Indice de gravité de la maladie (MeSH)</term><term>Infections à coronavirus (thérapie)</term><term>Mâle (MeSH)</term><term>Norme de soins (MeSH)</term><term>Pandémies (MeSH)</term><term>Pneumopathie virale (thérapie)</term><term>Résultat thérapeutique (MeSH)</term><term>Soins de réanimation (méthodes)</term><term>Sujet âgé (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Calcium Release Activated Calcium Channels</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Canaux calciques activés par la libération de calcium</term></keywords><keywords scheme="MESH" qualifier="methods" xml:lang="en"><term>Critical Care</term></keywords><keywords scheme="MESH" qualifier="méthodes" xml:lang="fr"><term>Soins de réanimation</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Coronavirus Infections</term><term>Pneumonia, Viral</term></keywords><keywords scheme="MESH" qualifier="thérapie" xml:lang="fr"><term>Infections à coronavirus</term><term>Pneumopathie virale</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Pandemics</term><term>Severity of Illness Index</term><term>Standard of Care</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Adulte d'âge moyen</term><term>Femelle</term><term>Humains</term><term>Indice de gravité de la maladie</term><term>Mâle</term><term>Norme de soins</term><term>Pandémies</term><term>Résultat thérapeutique</term><term>Sujet âgé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">32795330</PMID><DateCompleted><Year>2020</Year><Month>08</Month><Day>20</Day></DateCompleted><DateRevised><Year>2020</Year><Month>08</Month><Day>20</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1466-609X</ISSN><JournalIssue CitedMedium="Internet"><Volume>24</Volume><Issue>1</Issue><PubDate><Year>2020</Year><Month>08</Month><Day>14</Day></PubDate></JournalIssue><Title>Critical care (London, England)</Title><ISOAbbreviation>Crit Care</ISOAbbreviation></Journal><ArticleTitle>Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.</ArticleTitle><Pagination><MedlinePgn>502</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13054-020-03220-x</ELocationID><Abstract><AbstractText Label="BACKGROUND">Calcium release-activated calcium (CRAC) channel inhibitors stabilize the pulmonary endothelium and block proinflammatory cytokine release, potentially mitigating respiratory complications observed in patients with COVID-19. This study aimed to investigate the safety and efficacy of Auxora, a novel, intravenously administered CRAC channel inhibitor, in adults with severe or critical COVID-19 pneumonia.</AbstractText><AbstractText Label="METHODS">A randomized, controlled, open-label study of Auxora was conducted in adults with severe or critical COVID-19 pneumonia. Patients were randomized 2:1 to receive three doses of once-daily Auxora versus standard of care (SOC) alone. The primary objective was to assess the safety and tolerability of Auxora. Following FDA guidance, study enrollment was halted early to allow for transition to a randomized, blinded, placebo-controlled study.</AbstractText><AbstractText Label="RESULTS">In total, 17 patients with severe and three with critical COVID-19 pneumonia were randomized to Auxora and nine with severe and one with critical COVID-19 pneumonia to SOC. Similar proportions of patients receiving Auxora and SOC experienced ≥ 1 adverse event (75% versus 80%, respectively). Fewer patients receiving Auxora experienced serious adverse events versus SOC (30% versus 50%, respectively). Two patients (10%) receiving Auxora and two (20%) receiving SOC died during the 30 days after randomization. Among patients with severe COVID-19 pneumonia, the median time to recovery with Auxora was 5 days versus 12 days with SOC; the recovery rate ratio was 1.87 (95% CI, 0.72, 4.89). Invasive mechanical ventilation was needed in 18% of patients with severe COVID-19 pneumonia receiving Auxora versus 50% receiving SOC (absolute risk reduction = 32%; 95% CI, - 0.07, 0.71). Outcomes measured by an 8-point ordinal scale were significantly improved for patients receiving Auxora, especially for patients with a baseline PaO<sub>2</sub>/FiO<sub>2</sub> = 101-200.</AbstractText><AbstractText Label="CONCLUSIONS">Auxora demonstrated a favorable safety profile in patients with severe or critical COVID-19 pneumonia and improved outcomes in patients with severe COVID-19 pneumonia. These results, however, are limited by the open-label study design and small patient population resulting from the early cessation of enrollment in response to regulatory guidance. The impact of Auxora on respiratory complications in patients with severe COVID-19 pneumonia will be further assessed in a planned randomized, blinded, placebo-controlled study.</AbstractText><AbstractText Label="TRIAL REGISTRATION">ClinicalTrials.gov, NCT04345614 . Submitted on 7 April 2020.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Miller</LastName><ForeName>Joseph</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Henry Ford Hospital System, Detroit, MI, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Bruen</LastName><ForeName>Charles</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Regions Hospital, Health Partners, St. Paul, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Schnaus</LastName><ForeName>Michael</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Regions Hospital, Health Partners, St. Paul, MN, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</Affiliation></AffiliationInfo><AffiliationInfo><Affiliation>University of Minnesota, Minneapolis, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Jeffrey</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Princeton Pharmatech, Princeton, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ali</LastName><ForeName>Sadia</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lind</LastName><ForeName>April</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stoecker</LastName><ForeName>Zachary</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Methodist Hospital, Park Nicollet, St. Louis Park, MN, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Stauderman</LastName><ForeName>Kenneth</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hebbar</LastName><ForeName>Sudarshan</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>CalciMedica, Inc., 505 Coast Blvd. South Suite 202, La Jolla, CA, 92037, USA. sudarshan@calcimedica.com.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT04345614</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2020</Year><Month>08</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Crit Care</MedlineTA><NlmUniqueID>9801902</NlmUniqueID><ISSNLinking>1364-8535</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000071739">Calcium Release Activated Calcium Channels</NameOfSubstance></Chemical></ChemicalList><SupplMeshList><SupplMeshName Type="Disease" UI="C000657245">COVID-19</SupplMeshName></SupplMeshList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000071739" MajorTopicYN="N">Calcium Release Activated Calcium Channels</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="Y">antagonists & inhibitors</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018352" MajorTopicYN="N">Coronavirus Infections</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003422" MajorTopicYN="N">Critical Care</DescriptorName><QualifierName UI="Q000379" MajorTopicYN="Y">methods</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008297" MajorTopicYN="N">Male</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D058873" MajorTopicYN="N">Pandemics</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D011024" MajorTopicYN="N">Pneumonia, Viral</DescriptorName><QualifierName UI="Q000628" MajorTopicYN="Y">therapy</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012720" MajorTopicYN="N">Severity of Illness Index</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D059039" MajorTopicYN="N">Standard of Care</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="Y">COVID-19 pneumonia</Keyword><Keyword MajorTopicYN="Y">CRAC channel inhibitors</Keyword><Keyword MajorTopicYN="Y">Calcium release-activated calcium channel inhibitors</Keyword><Keyword MajorTopicYN="Y">Proinflammatory response</Keyword><Keyword MajorTopicYN="Y">Pulmonary endothelium</Keyword><Keyword MajorTopicYN="Y">Respiratory complications</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2020</Year><Month>06</Month><Day>26</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2020</Year><Month>08</Month><Day>03</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2020</Year><Month>8</Month><Day>16</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2020</Year><Month>8</Month><Day>17</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2020</Year><Month>8</Month><Day>21</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">32795330</ArticleId><ArticleId IdType="doi">10.1186/s13054-020-03220-x</ArticleId><ArticleId IdType="pii">10.1186/s13054-020-03220-x</ArticleId><ArticleId IdType="pmc">PMC7427272</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>Cell Calcium. 2018 Sep;74:147-159</Citation><ArticleIdList><ArticleId IdType="pubmed">30075400</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 May 22;:</Citation><ArticleIdList><ArticleId IdType="pubmed">32445440</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 Jul 9;383(2):120-128</Citation><ArticleIdList><ArticleId IdType="pubmed">32437596</ArticleId></ArticleIdList></Reference><Reference><Citation>J Physiol. 2019 Jun;597(12):3085-3105</Citation><ArticleIdList><ArticleId IdType="pubmed">31050811</ArticleId></ArticleIdList></Reference><Reference><Citation>JAMA Intern Med. 2020 Mar 13;:</Citation><ArticleIdList><ArticleId IdType="pubmed">32167524</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Invest. 2013 Mar;123(3):1015-8</Citation><ArticleIdList><ArticleId IdType="pubmed">23434597</ArticleId></ArticleIdList></Reference><Reference><Citation>Annu Rev Immunol. 2015;33:291-353</Citation><ArticleIdList><ArticleId IdType="pubmed">25861976</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 May 15;:</Citation><ArticleIdList><ArticleId IdType="pubmed">32412710</ArticleId></ArticleIdList></Reference><Reference><Citation>Crit Care Med. 2017 Aug;45(8):1317-1324</Citation><ArticleIdList><ArticleId IdType="pubmed">28538439</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 Feb 15;395(10223):497-506</Citation><ArticleIdList><ArticleId IdType="pubmed">31986264</ArticleId></ArticleIdList></Reference><Reference><Citation>Gastroenterology. 2015 Aug;149(2):481-92.e7</Citation><ArticleIdList><ArticleId IdType="pubmed">25917787</ArticleId></ArticleIdList></Reference><Reference><Citation>N Engl J Med. 2020 Jul 17;:</Citation><ArticleIdList><ArticleId IdType="pubmed">32678530</ArticleId></ArticleIdList></Reference><Reference><Citation>Aging (Albany NY). 2020 May 27;12(10):8760-8765</Citation><ArticleIdList><ArticleId IdType="pubmed">32463794</ArticleId></ArticleIdList></Reference><Reference><Citation>Inflammation. 2016 Jun;39(3):1049-58</Citation><ArticleIdList><ArticleId IdType="pubmed">27025854</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Invest. 2013 Feb;123(2):887-902</Citation><ArticleIdList><ArticleId IdType="pubmed">23348743</ArticleId></ArticleIdList></Reference><Reference><Citation>Chest. 2016 Aug;150(2):307-13</Citation><ArticleIdList><ArticleId IdType="pubmed">26836924</ArticleId></ArticleIdList></Reference><Reference><Citation>Front Immunol. 2017 Jul 04;8:757</Citation><ArticleIdList><ArticleId IdType="pubmed">28725223</ArticleId></ArticleIdList></Reference><Reference><Citation>Lancet. 2020 Mar 28;395(10229):1033-1034</Citation><ArticleIdList><ArticleId IdType="pubmed">32192578</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>États-Unis</li></country><region><li>Michigan</li><li>Minnesota</li><li>New Jersey</li></region></list><tree><country name="États-Unis"><region name="Michigan"><name sortKey="Miller, Joseph" sort="Miller, Joseph" uniqKey="Miller J" first="Joseph" last="Miller">Joseph Miller</name></region><name sortKey="Ali, Sadia" sort="Ali, Sadia" uniqKey="Ali S" first="Sadia" last="Ali">Sadia Ali</name><name sortKey="Bruen, Charles" sort="Bruen, Charles" uniqKey="Bruen C" first="Charles" last="Bruen">Charles Bruen</name><name sortKey="Hebbar, Sudarshan" sort="Hebbar, Sudarshan" uniqKey="Hebbar S" first="Sudarshan" last="Hebbar">Sudarshan Hebbar</name><name sortKey="Lind, April" sort="Lind, April" uniqKey="Lind A" first="April" last="Lind">April Lind</name><name sortKey="Schnaus, Michael" sort="Schnaus, Michael" uniqKey="Schnaus M" first="Michael" last="Schnaus">Michael Schnaus</name><name sortKey="Schnaus, Michael" sort="Schnaus, Michael" uniqKey="Schnaus M" first="Michael" last="Schnaus">Michael Schnaus</name><name sortKey="Schnaus, Michael" sort="Schnaus, Michael" uniqKey="Schnaus M" first="Michael" last="Schnaus">Michael Schnaus</name><name sortKey="Stauderman, Kenneth" sort="Stauderman, Kenneth" uniqKey="Stauderman K" first="Kenneth" last="Stauderman">Kenneth Stauderman</name><name sortKey="Stoecker, Zachary" sort="Stoecker, Zachary" uniqKey="Stoecker Z" first="Zachary" last="Stoecker">Zachary Stoecker</name><name sortKey="Zhang, Jeffrey" sort="Zhang, Jeffrey" uniqKey="Zhang J" first="Jeffrey" last="Zhang">Jeffrey Zhang</name></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Sante/explor/CovidSeniorV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000908 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000908 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Sante
|area= CovidSeniorV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= pubmed:32795330
|texte= Auxora versus standard of care for the treatment of severe or critical COVID-19 pneumonia: results from a randomized controlled trial.
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:32795330" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a CovidSeniorV1
| This area was generated with Dilib version V0.6.37. |  |