A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of thymoquinone formula (TQF) for treating outpatient SARS-CoV-2

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dc.authorid0000-0002-3386-1734
dc.contributor.authorBencheqroun, Hassan
dc.contributor.authorAhmed, Yasir
dc.contributor.authorKoçak, Mehmet
dc.contributor.authorVilla, Enrique
dc.contributor.authorBarrera, Cesar
dc.contributor.authorMohiuddin, Mariya
dc.contributor.authorFortunet, Raul
dc.contributor.authorIyoha, Emmanuel
dc.contributor.authorBates, Deborah
dc.contributor.authorOkpalor, Chinedu
dc.contributor.authorAgbosasa, Ola
dc.contributor.authorMohammed, Karim
dc.contributor.authorPondell, Stephen
dc.contributor.authorMohamed, Amr
dc.contributor.authorMohamed, Yehia I.
dc.contributor.authorGök Yavuz, Betül
dc.contributor.authorKaseb, Mohamed O.
dc.contributor.authorKasseb, Osama O.
dc.contributor.authorGocio, Michelle York
dc.contributor.authorTu, Peter Tsu-Man
dc.contributor.authorLi, Dan
dc.contributor.authorLu, Jianming
dc.contributor.authorSelim, Abdulhafez
dc.contributor.authorMa, Qing
dc.contributor.authorKaseb, Ahmed O.
dc.date.accessioned2022-12-15T09:02:21Z
dc.date.available2022-12-15T09:02:21Z
dc.date.issued2022
dc.departmentİstanbul Medipol Üniversitesi, Tıp Fakültesi, Temel Tıp Bilimleri Bölümü, Biyoistatistik ve Tıp Bilişimi Ana Bilim Dalı
dc.description.abstractThere is an urgent need for an oral drug for the treatment of mild to moderate outpatient SARS-CoV-2. Our preclinical and clinical study's aim was to determine the safety and preliminary efficacy of oral TQ Formula (TQF), in the treatment of outpatient SARS-CoV-2. In a double-blind, placebo-controlled phase 2 trial, we randomly assigned (1:1 ratio) non-hospitalized, adult (>18 years), symptomatic SARS-CoV-2 patients to receive oral TQF or placebo. The primary endpoints were safety and the median time-to-sustained-clinical-response (SCR). SCR was 6 days in the TQF arm vs. 8 days in the placebo arm (p = 0.77), and 5 days in the TQF arm vs. 7.5 days in the placebo arm in the high-risk cohort, HR 1.55 (95% CI: 0.70, 3.43, p = 0.25). No significant difference was found in the rate of AEs (p = 0.16). TQF led to a significantly faster decline in the total symptom burden (TSB) (p < 0.001), and a significant increase in cytotoxic CD8(+) (p = 0.042) and helper CD4(+) (p = 0.042) central memory T lymphocytes. TQF exhibited an in vitro inhibitory effect on the entry of five SARS-CoV-2 variants. TQF was well-tolerated. While the median time-to-SCR did not reach statistical significance; it was shorter in the TQF arm and preclinical/clinical signals of TQF activity across multiple endpoints were significant. Therefore, a confirmatory study is planned.
dc.description.sponsorshipTakeda Pharmaceutical Company Ltden_US
dc.identifier.citationBencheqroun, H., Ahmed, Y., Koçak, M., Villa, E., Barrera, C., Mohiuddin, M. ... Kaseb, A. O. (2022). A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of thymoquinone formula (TQF) for treating outpatient SARS-CoV-2. Pathogens, 11(5). https://doi.org/10.3390/pathogens11050551
dc.identifier.doi10.3390/pathogens11050551
dc.identifier.issn2076-0817
dc.identifier.issue5
dc.identifier.pmid35631072
dc.identifier.scopus2-s2.0-85130209060
dc.identifier.scopusqualityQ2
dc.identifier.urihttps://doi.org/10.3390/pathogens11050551
dc.identifier.urihttps://hdl.handle.net/20.500.12511/10126
dc.identifier.volume11
dc.identifier.wos000801600500001en_US
dc.identifier.wosqualityQ2
dc.indekslendigikaynakWeb of Science
dc.indekslendigikaynakScopus
dc.indekslendigikaynakPubMed
dc.institutionauthorKoçak, Mehmet
dc.language.isoen
dc.publisherMDPI
dc.relation.ispartofPathogensen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı
dc.rightsAttribution 4.0 International*
dc.rightsinfo:eu-repo/semantics/openAccess
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/*
dc.subjectCoronavirus
dc.subjectCOVID-19
dc.subjectPandemic
dc.subjectSARS-CoV-2
dc.subjectTQ Formula
dc.titleA randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of thymoquinone formula (TQF) for treating outpatient SARS-CoV-2
dc.typeArticle

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