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All Studies   All Outcomes    Recent:   

Evaluation of Acebilustat, a Selective Inhibitor of Leukotriene B4 Biosynthesis, for Treatment of Outpatients With Mild-Moderate Coronavirus Disease 2019: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial

Levitt et al., Clinical Infectious Diseases, doi:10.1093/cid/ciad187, NCT04662060
Mar 2023  
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Hospitalization 0% Improvement Relative Risk ER visit 80% Sustained symp. resolution -67% First symptom resolution -61% Viral clearance 6% no CI Acebilustat  Levitt et al.  EARLY TREATMENT  DB RCT Is early treatment with acebilustat beneficial for COVID-19? Double-blind RCT 120 patients in the USA (April 2021 - April 2022) Lower progression (p=0.21) and worse recovery (p=0.07), not sig. c19early.org Levitt et al., Clinical Infectious Dis.., Mar 2023 Favorsacebilustat Favorscontrol 0 0.5 1 1.5 2+
RCT 120 outpatients showing no significant difference in time to sustained symptom resolution or viral clearance with acebilustat treatment. Subgroup analyses showed consistent patterns of longer symptom duration in treated participants.
risk of hospitalization, no change, RR 1.00, p = 1.00, treatment 1 of 60 (1.7%), control 1 of 60 (1.7%).
ER visit, 80.0% lower, RR 0.20, p = 0.21, treatment 1 of 60 (1.7%), control 5 of 60 (8.3%), NNT 15.
sustained symptom resolution, 66.7% higher, HR 1.67, p = 0.07, treatment 60, control 60, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards.
first symptom resolution, 61.3% higher, HR 1.61, p = 0.05, treatment 60, control 60, adjusted per study, inverted to make HR<1 favor treatment, multivariable, Cox proportional hazards.
risk of no viral clearance, 5.9% lower, RR 0.94, treatment 60, control 60.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Levitt et al., 30 Mar 2023, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, median age 41.0, 20 authors, study period 22 April, 2021 - 5 April, 2022, trial NCT04662060 (history). Contact: jlevitt@stanford.edu.
This PaperAcebilustatAll
Evaluation of Acebilustat, a Selective Inhibitor of Leukotriene B4 Biosynthesis, for Treatment of Outpatients With Mild-Moderate Coronavirus Disease 2019: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial
Joseph E Levitt, Haley Hedlin, Sophie Duong, Di Lu, Justin Lee, Bryan Bunning, Nadia Elkarra, Benjamin A Pinsky, Eileen Heffernan, Eric Springman, Richard B Moss, Hector F Bonilla, Julie Parsonnet, Roham T Zamanian, Jamison J Langguth, Jenna Bollyky, Chaitan Khosla, Mark R Nicolls, Manisha Desai, Angela J Rogers
Clinical Infectious Diseases, doi:10.1093/cid/ciad187
Background. The vast majority of coronavirus disease 2019 (COVID-19) disease occurs in outpatients where treatment is limited to antivirals for high-risk subgroups. Acebilustat, a leukotriene B4 inhibitor, has potential to reduce inflammation and symptom duration. Methods. In a single-center trial spanning Delta and Omicron variants, outpatients were randomized to 100 mg/d of oral acebilustat or placebo for 28 days. Patients reported daily symptoms via electronic query through day 28 with phone follow-up on day 120 and collected nasal swab samples on days 1-10. The primary outcome was sustained symptom resolution to day 28. Secondary 28-day outcomes included time to first symptom resolution, area under the curve (AUC) for longitudinal daily symptom scores, duration of viral shedding through day 10, and symptoms on day 120. Results. Sixty participants were randomized to each study arm. At enrollment, the median duration was 4 days (interquartile range, 3-5 days), and the median number of symptoms was 9 (7-11). Most patients (90%) were vaccinated, with 73% having neutralizing antibodies. A minority of participants (44%; 35% in the acebilustat arm and 53% in placebo) had sustained symptom resolution at day 28 (hazard ratio, 0.6 [95% confidence interval, .34-1.04]; P = .07 favoring placebo). There was no difference in the mean AUC for symptom scores over 28 days (difference in mean AUC, 9.4 [95% confidence interval, -42.1 to 60.9]; P = .72). Acebilustat did not affect viral shedding or symptoms at day 120. Conclusions. Sustained symptoms through day 28 were common in this low-risk population. Despite this, leukotriene B4 antagonism with acebilustat did not shorten symptom duration in outpatients with COVID-19. Clinical Trials Registration. NCT04662060.
Supplementary Data Supplementary materials are available at Clinical Infectious Diseases online. Consisting of data provided by the authors to benefit the reader, the posted materials are not copyedited and are the sole responsibility of the authors, so questions or comments should be addressed to the corresponding author. Notes Acknowledgments. We
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' 'Acebilustat, a leukotriene B4 inhibitor, has potential to reduce inflammation and symptom ' 'duration.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Methods</jats:title>\n' ' <jats:p>In a single-center trial spanning Delta and Omicron variants, ' 'outpatients were randomized to 100 mg/d of oral acebilustat or placebo for 28 days. Patients ' 'reported daily symptoms via electronic query through day 28 with phone follow-up on day 120 ' 'and collected nasal swab samples on days 1–10. The primary outcome was sustained symptom ' 'resolution to day 28. Secondary 28-day outcomes included time to first symptom resolution, ' 'area under the curve (AUC) for longitudinal daily symptom scores, duration of viral shedding ' 'through day 10, and symptoms on day 120.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>Sixty participants were randomized to each study arm. At ' 'enrollment, the median duration was 4 days (interquartile range, 3–5 days), and the median ' 'number of symptoms was 9 (7–11). Most patients (90%) were vaccinated, with 73% having ' 'neutralizing antibodies. A minority of participants (44%; 35% in the acebilustat arm and 53% ' 'in placebo) had sustained symptom resolution at day 28 (hazard ratio, 0.6 [95% confidence ' 'interval, .34–1.04]; P = .07 favoring placebo). There was no difference in the mean AUC for ' 'symptom scores over 28 days (difference in mean AUC, 9.4 [95% confidence interval, −42.1 to ' '60.9]; P = .72). Acebilustat did not affect viral shedding or symptoms at day 120.</jats:p>\n' ' </jats:sec>\n' ' <jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>Sustained symptoms through day 28 were common in this low-risk ' 'population. 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'placebo-controlled, phase 2 trial', 'volume': '75', 'author': 'Holubar', 'year': '2022', 'journal-title': 'Clin Infect Dis'}, { 'key': '2023092304121090100_ciad187-B22', 'doi-asserted-by': 'crossref', 'first-page': '1967', 'DOI': '10.1038/s41467-021-22177-1', 'article-title': 'Peginterferon lambda-1a for treatment of outpatients with uncomplicated ' 'COVID-19: a randomized placebo-controlled trial', 'volume': '12', 'author': 'Jagannathan', 'year': '2021', 'journal-title': 'Nat Commun'}, { 'key': '2023092304121090100_ciad187-B23', 'doi-asserted-by': 'crossref', 'first-page': '763', 'DOI': '10.1016/S2213-2600(21)00160-0', 'article-title': 'Inhaled budesonide in the treatment of early COVID-19 (STOIC): a phase ' '2, open-label, randomised controlled trial', 'volume': '9', 'author': 'Ramakrishnan', 'year': '2021', 'journal-title': 'Lancet Respir Med'}, { 'key': '2023092304121090100_ciad187-B24', 'doi-asserted-by': 'crossref', 'first-page': '42', 'DOI': '10.1001/jamainternmed.2021.6759', 'article-title': 'Efficacy of inhaled ciclesonide for outpatient treatment of adolescents ' 'and adults with symptomatic COVID-19: a randomized clinical trial', 'volume': '182', 'author': 'Clemency', 'year': '2022', 'journal-title': 'JAMA Intern Med'}, { 'key': '2023092304121090100_ciad187-B25', 'doi-asserted-by': 'crossref', 'first-page': '1010', 'DOI': '10.1016/j.cmi.2022.02.031', 'article-title': 'Inhaled ciclesonide for outpatient treatment of COVID-19 in adults at ' 'risk of adverse outcomes: a randomised controlled trial (COVERAGE)', 'volume': '28', 'author': 'Duvignaud', 'year': '2022', 'journal-title': 'Clin Microbiol Infect'}, { 'key': '2023092304121090100_ciad187-B26', 'doi-asserted-by': 'crossref', 'first-page': '2292', 'DOI': '10.1001/jama.2020.22760', 'article-title': 'Fluvoxamine vs placebo and clinical deterioration in outpatients with ' 'symptomatic COVID-19: a randomized clinical trial', 'volume': '324', 'author': 'Lenze', 'year': '2020', 'journal-title': 'JAMA'}, { 'key': '2023092304121090100_ciad187-B27', 'doi-asserted-by': 'crossref', 'first-page': 'e42', 'DOI': '10.1016/S2214-109X(21)00448-4', 'article-title': 'Effect of early treatment with fluvoxamine on risk of emergency care ' 'and hospitalisation among patients with COVID-19: the TOGETHER ' 'randomised, platform clinical trial', 'volume': '10', 'author': 'Reis', 'year': '2022', 'journal-title': 'Lancet Glob Health'}, {'key': '2023092304121090100_ciad187-B28', 'author': 'McCarthy', 'year': '1 2022'}, { 'key': '2023092304121090100_ciad187-B29', 'doi-asserted-by': 'crossref', 'first-page': '924', 'DOI': '10.1016/S2213-2600(21)00222-8', 'article-title': 'Colchicine for community-treated patients with COVID-19 (COLCORONA): a ' 'phase 3, randomised, double-blinded, adaptive, placebo-controlled, ' 'multicentre trial', 'volume': '9', 'author': 'Tardif', 'year': '2021', 'journal-title': 'Lancet Respir Med'}, { 'key': '2023092304121090100_ciad187-B30', 'doi-asserted-by': 'crossref', 'first-page': '1130', 'DOI': '10.1016/S2213-2600(21)00263-0', 'article-title': 'Azithromycin versus standard care in patients with mild-to-moderate ' 'COVID-19 (ATOMIC2): an open-label, randomised trial', 'volume': '9', 'author': 'Hinks', 'year': '2021', 'journal-title': 'Lancet Respir Med'}, { 'key': '2023092304121090100_ciad187-B31', 'doi-asserted-by': 'crossref', 'first-page': '490', 'DOI': '10.1001/jama.2021.11517', 'article-title': 'Effect of oral azithromycin vs placebo on COVID-19 symptoms in ' 'outpatients with SARS-CoV-2 infection: a randomized clinical trial', 'volume': '326', 'author': 'Oldenburg', 'year': '2021', 'journal-title': 'JAMA'}, { 'key': '2023092304121090100_ciad187-B32', 'doi-asserted-by': 'crossref', 'first-page': '879', 'DOI': '10.1136/gutjnl-2022-326952', 'article-title': 'Oral famotidine versus placebo in non-hospitalised patients with ' 'COVID-19: a randomised, double-blind, data-intense, phase 2 clinical ' 'trial', 'volume': '71', 'author': 'Brennan', 'year': '2022', 'journal-title': 'Gut'}, { 'key': '2023092304121090100_ciad187-B33', 'doi-asserted-by': 'crossref', 'first-page': '472', 'DOI': '10.1186/s13063-022-06375-w', 'article-title': 'The efficacy of curcumin-piperine co-supplementation on clinical ' 'symptoms, duration, severity, and inflammatory factors in COVID-19 ' 'outpatients: a randomized double-blind, placebo-controlled trial', 'volume': '23', 'author': 'Askari', 'year': '2022', 'journal-title': 'Trials'}, { 'key': '2023092304121090100_ciad187-B34', 'doi-asserted-by': 'crossref', 'DOI': '10.1126/scitranslmed.aal3920', 'article-title': 'Leukotriene B4 antagonism ameliorates experimental lymphedema', 'volume': '9', 'author': 'Tian', 'year': '2017', 'journal-title': 'Sci Transl Med'}, { 'key': '2023092304121090100_ciad187-B35', 'doi-asserted-by': 'crossref', 'first-page': '1637', 'DOI': '10.1016/S0140-6736(21)00676-0', 'article-title': 'Tocilizumab in patients admitted to hospital with COVID-19 (RECOVERY): ' 'a randomised, controlled, open-label, platform trial', 'volume': '397', 'author': 'RECOVERY Collaborative Group', 'year': '2021', 'journal-title': 'Lancet'}, { 'key': '2023092304121090100_ciad187-B36', 'doi-asserted-by': 'crossref', 'first-page': '1491', 'DOI': '10.1056/NEJMoa2100433', 'article-title': 'Interleukin-6 receptor antagonists in critically ill patients with ' 'Covid-19', 'volume': '384', 'author': 'REMAP-CAP Investigators', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2023092304121090100_ciad187-B37', 'doi-asserted-by': 'crossref', 'first-page': '795', 'DOI': '10.1056/NEJMoa2031994', 'article-title': 'Baricitinib plus remdesivir for hospitalized adults with Covid-19', 'volume': '384', 'author': 'Kalil', 'year': '2021', 'journal-title': 'N Engl J Med'}, { 'key': '2023092304121090100_ciad187-B38', 'doi-asserted-by': 'crossref', 'first-page': '1401', 'DOI': '10.7326/M22-0924', 'article-title': 'The association of baseline plasma SARS-CoV-2 nucleocapsid antigen ' 'level and outcomes in patients hospitalized with COVID-19', 'volume': '175', 'author': 'ACTIV-3/TICO Study Group', 'year': '2022', 'journal-title': 'Ann Intern Med'}], 'container-title': 'Clinical Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://academic.oup.com/cid/advance-article-pdf/doi/10.1093/cid/ciad187/50310958/ciad187.pdf', 'content-type': 'application/pdf', 'content-version': 'am', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/cid/article-pdf/77/2/186/51728055/ciad187.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'syndication'}, { 'URL': 'https://academic.oup.com/cid/article-pdf/77/2/186/51728055/ciad187.pdf', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 9, 23]], 'date-time': '2023-09-23T04:12:58Z', 'timestamp': 1695442378000}, 'score': 1, 'resource': {'primary': {'URL': 'https://academic.oup.com/cid/article/77/2/186/7095671'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 3, 30]]}, 'references-count': 38, 'journal-issue': { 'issue': '2', 'published-online': {'date-parts': [[2023, 3, 30]]}, 'published-print': {'date-parts': [[2023, 7, 26]]}}, 'URL': 'http://dx.doi.org/10.1093/cid/ciad187', 'relation': {}, 'ISSN': ['1058-4838', '1537-6591'], 'subject': [], 'published-other': {'date-parts': [[2023, 7, 15]]}, 'published': {'date-parts': [[2023, 3, 30]]}}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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