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Recent:   

Camostat Mesylate Versus Lopinavir/Ritonavir in Hospitalized Patients With COVID-19—Results From a Randomized, Controlled, Open Label, Platform Trial (ACOVACT)

Karolyi et al., Frontiers in Pharmacology, doi:10.3389/fphar.2022.870493, ACOVACT, NCT04351724
Jul 2022  
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Mortality 72% Improvement Relative Risk Ventilation 70% Death/intubation 60% Time to sustained clinical.. 18% primary Time to improvement ≥2 c.. 8% Hospitalization time 14% Camostat  ACOVACT  LATE TREATMENT  RCT Is late treatment with camostat beneficial for COVID-19? RCT 201 patients in Austria (April 2020 - May 2021) Trial compares with lopinavir/ritonavir, results vs. placebo may differ Lower ventilation (p=0.024) and death/intubation (p=0.04) c19early.org Karolyi et al., Frontiers in Pharmacol.., Jul 2022 Favorscamostat Favorslopinavir/ri.. 0 0.5 1 1.5 2+
RCT 201 hospitalized COVID-19 patients showing faster clinical improvement, less progression to mechanical ventilation or death, and shorter hospital stay with camostat mesylate compared to lopinavir/ritonavir. There was also a trend towards lower 29-day mortality with camostat. Authors note that the lopinavir/ritonavir dose likely did not reach effective levels, so it may be considered similar to a placebo group.
risk of death, 71.7% lower, RR 0.28, p = 0.10, treatment 2 of 101 (2.0%), control 7 of 100 (7.0%), NNT 20.
risk of mechanical ventilation, 69.5% lower, RR 0.30, p = 0.02, treatment 4 of 101 (4.0%), control 13 of 100 (13.0%), NNT 11.
risk of death/intubation, 60.4% lower, RR 0.40, p = 0.04, treatment 6 of 101 (5.9%), control 15 of 100 (15.0%), NNT 11.
relative time to sustained clinical improvement, 18.2% lower, relative time 0.82, p = 0.005, treatment 101, control 100, primary outcome.
relative time to improvement ≥2 categories, 7.7% lower, relative time 0.92, p = 0.02, treatment 101, control 100.
hospitalization time, 14.3% lower, relative time 0.86, p = 0.02, treatment 101, control 100.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Karolyi et al., 22 Jul 2022, Randomized Controlled Trial, Austria, peer-reviewed, mean age 58.6, 21 authors, study period 20 April, 2020 - 14 May, 2021, this trial compares with another treatment - results may be better when compared to placebo, trial NCT04351724 (history) (ACOVACT). Contact: mario.karolyi@gesundheitsverbund.at.
This PaperMiscellaneousAll
Camostat Mesylate Versus Lopinavir/Ritonavir in Hospitalized Patients With COVID-19—Results From a Randomized, Controlled, Open Label, Platform Trial (ACOVACT)
M Karolyi, E Pawelka, S Omid, F Koenig, V Kauer, B Rumpf, W Hoepler, A Kuran, H Laferl, T Seitz, M Traugott, V Rathkolb, M Mueller, A Abrahamowicz, C Schoergenhofer, M Hecking, A Assinger, C Wenisch, M Zeitlinger, B Jilma, A Zoufaly
Frontiers in Pharmacology, doi:10.3389/fphar.2022.870493
Background: To date, no oral antiviral drug has proven to be beneficial in hospitalized patients with COVID-19. Methods: In this randomized, controlled, open-label, platform trial, we randomly assigned patients ≥18 years hospitalized with COVID-19 pneumonia to receive either camostat mesylate (CM) (considered standard-of-care) or lopinavir/ritonavir (LPV/RTV). The primary endpoint was time to sustained clinical improvement (≥48 h) of at least one point on the 7category WHO scale. Secondary endpoints included length of stay (LOS), need for mechanical ventilation (MV) or death, and 29-day mortality. Results: 201 patients were included in the study (101 CM and 100 LPV/RTV) between 20 April 2020 and 14 May 2021. Mean age was 58.7 years, and 67% were male. The median time from symptom onset to randomization was 7 days (IQR 5-9). Patients in the CM group had a significantly shorter time to sustained clinical improvement (HR = 0.67, 95%-CI 0.49-0.90; 9 vs. 11 days, p = 0.008) and demonstrated less progression to MV or death [6/101 (5.9%) vs. 15/100 (15%), p = 0.036] and a shorter LOS (12 vs. 14 days, p = 0.023). A statistically nonsignificant trend toward a lower 29-day mortality in the CM group than the LPV/RTV group [2/101 (2%) vs. 7/100 (7%), p = 0.089] was observed. Conclusion: In patients hospitalized for COVID-19, the use of CM was associated with shorter time to clinical improvement, reduced need for MV or death, and shorter LOS than the use of LPV/RTV. Furthermore, research is needed to confirm the efficacy of CM in larger placebo-controlled trials.
ETHICS STATEMENT The studies involving human participants were reviewed and approved and all amendments during the study period were approved by the ethics committee of the Medical University of Vienna and Vienna ethics committee. All methods were carried out in accordance with the ethical principles of the Declaration of Helsinki. All patients included in the trial signed an informed consent form. The patients/participants provided their written informed consent to participate in this study. AUTHOR CONTRIBUTIONS MK and EP wrote the manuscript. MK, EP, SO, AK, HL, VK, BR, TS, VR, MM, and AgA recruited patients for the study and collected the data. FK and MK were responsible for statistical analysis. AZ, CW, BJ, MH, and MZ conceptualized the idea and designed the study. AZ, BJ, CS, and MH wrote the study protocol and ethics application. AlA, WH, SO, and MT proofread the manuscript and helped interpret the data. AZ, CW, and BJ supervised the study. MZ was responsible for all regulatory and legal aspects of the study. SUPPLEMENTARY MATERIAL The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fphar.2022.870493/ full#supplementary-material Conflict of Interest: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Publisher's Note: All claims expressed in this article are solely those of the authors..
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The primary endpoint was time to sustained clinical ' 'improvement (≥48\xa0h) of at least one point on the 7-category WHO scale. Secondary endpoints ' 'included length of stay (LOS), need for mechanical ventilation (MV) or death, and 29-day ' 'mortality.</jats:p><jats:p><jats:bold>Results:</jats:bold> 201 patients were included in the ' 'study (101 CM and 100 LPV/RTV) between 20 April 2020 and 14 May 2021. Mean age was 58.7\xa0' 'years, and 67% were male. The median time from symptom onset to randomization was 7\xa0days ' '(IQR 5–9). Patients in the CM group had a significantly shorter time to sustained clinical ' 'improvement (HR = 0.67, 95%-CI 0.49–0.90; 9 vs. 11\xa0days, <jats:italic>p</jats:italic> = ' '0.008) and demonstrated less progression to MV or death [6/101 (5.9%) vs. 15/100 (15%), ' '<jats:italic>p</jats:italic> = 0.036] and a shorter LOS (12 vs. 14\xa0days, ' '<jats:italic>p</jats:italic> = 0.023). 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Intern Med.'}, { 'key': 'B28', 'doi-asserted-by': 'publisher', 'first-page': '640', 'DOI': '10.1038/d41586-021-02039-y', 'article-title': 'How the Coronavirus Infects Cells - and Why Delta Is So Dangerous', 'volume': '595', 'author': 'Scudellari', 'year': '2021', 'journal-title': 'Nature'}, { 'key': 'B29', 'doi-asserted-by': 'publisher', 'first-page': '440', 'DOI': '10.1159/000094561', 'article-title': 'Chronic Pancreatitis: Evolving Paradigms', 'volume': '6', 'author': 'Talukdar', 'year': '2006', 'journal-title': 'Pancreatology'}, { 'key': 'B30', 'doi-asserted-by': 'publisher', 'first-page': '732', 'DOI': '10.1093/cid/ciaa237', 'article-title': 'In Vitro Antiviral Activity and Projection of Optimized Dosing Design ' 'of Hydroxychloroquine for the Treatment of Severe Acute Respiratory ' 'Syndrome Coronavirus 2 (SARS-CoV-2)', 'volume': '71', 'author': 'Yao', 'year': '2020', 'journal-title': 'Clin. Infect. Dis.'}], 'container-title': 'Frontiers in Pharmacology', 'original-title': [], 'link': [ { 'URL': 'https://www.frontiersin.org/articles/10.3389/fphar.2022.870493/full', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 7, 22]], 'date-time': '2022-07-22T11:18:37Z', 'timestamp': 1658488717000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.frontiersin.org/articles/10.3389/fphar.2022.870493/full'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 7, 22]]}, 'references-count': 30, 'alternative-id': ['10.3389/fphar.2022.870493'], 'URL': 'http://dx.doi.org/10.3389/fphar.2022.870493', 'relation': {}, 'ISSN': ['1663-9812'], 'subject': ['Pharmacology (medical)', 'Pharmacology'], 'container-title-short': 'Front. Pharmacol.', 'published': {'date-parts': [[2022, 7, 22]]}}
Late treatment
is less effective
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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