dc.contributor.author | Bencheqroun, Hassan | |
dc.contributor.author | Ahmed, Yasir | |
dc.contributor.author | Koçak, Mehmet | |
dc.contributor.author | Villa, Enrique | |
dc.contributor.author | Barrera, Cesar | |
dc.contributor.author | Mohiuddin, Mariya | |
dc.contributor.author | Fortunet, Raul | |
dc.contributor.author | Iyoha, Emmanuel | |
dc.contributor.author | Bates, Deborah | |
dc.contributor.author | Okpalor, Chinedu | |
dc.contributor.author | Agbosasa, Ola | |
dc.contributor.author | Mohammed, Karim | |
dc.contributor.author | Pondell, Stephen | |
dc.contributor.author | Mohamed, Amr | |
dc.contributor.author | Mohamed, Yehia I. | |
dc.contributor.author | Gök Yavuz, Betül | |
dc.contributor.author | Kaseb, Mohamed O. | |
dc.contributor.author | Kasseb, Osama O. | |
dc.contributor.author | Gocio, Michelle York | |
dc.contributor.author | Tu, Peter Tsu-Man | |
dc.contributor.author | Li, Dan | |
dc.contributor.author | Lu, Jianming | |
dc.contributor.author | Selim, Abdulhafez | |
dc.contributor.author | Ma, Qing | |
dc.contributor.author | Kaseb, Ahmed O. | |
dc.date.accessioned | 2022-12-15T09:02:21Z | |
dc.date.available | 2022-12-15T09:02:21Z | |
dc.date.issued | 2022 | en_US |
dc.identifier.citation | Bencheqroun, 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 | en_US |
dc.identifier.issn | 2076-0817 | |
dc.identifier.uri | https://doi.org/10.3390/pathogens11050551 | |
dc.identifier.uri | https://hdl.handle.net/20.500.12511/10126 | |
dc.description.abstract | There 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. | en_US |
dc.description.sponsorship | Takeda Pharmaceutical Company Ltd | en_US |
dc.language.iso | eng | en_US |
dc.publisher | MDPI | en_US |
dc.rights | info:eu-repo/semantics/openAccess | en_US |
dc.rights | Attribution 4.0 International | * |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Coronavirus | en_US |
dc.subject | COVID-19 | en_US |
dc.subject | Pandemic | en_US |
dc.subject | SARS-CoV-2 | en_US |
dc.subject | TQ Formula | en_US |
dc.title | A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of thymoquinone formula (TQF) for treating outpatient SARS-CoV-2 | en_US |
dc.type | article | en_US |
dc.relation.ispartof | Pathogens | en_US |
dc.department | İstanbul Medipol Üniversitesi, Tıp Fakültesi, Temel Tıp Bilimleri Bölümü, Biyoistatistik ve Tıp Bilişimi Ana Bilim Dalı | en_US |
dc.authorid | 0000-0002-3386-1734 | en_US |
dc.identifier.volume | 11 | en_US |
dc.identifier.issue | 5 | en_US |
dc.relation.publicationcategory | Makale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanı | en_US |
dc.identifier.doi | 10.3390/pathogens11050551 | en_US |
dc.institutionauthor | Koçak, Mehmet | |
dc.identifier.wosquality | Q2 | en_US |
dc.identifier.wos | 000801600500001 | en_US |
dc.identifier.scopus | 2-s2.0-85130209060 | en_US |
dc.identifier.pmid | 35631072 | en_US |
dc.identifier.scopusquality | Q2 | en_US |