A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of thymoquinone formula (TQF) for treating outpatient SARS-CoV-2
Accessinfo:eu-repo/semantics/openAccessAttribution 4.0 Internationalhttps://creativecommons.org/licenses/by/4.0/
Mohamed, Yehia I.
Gök Yavuz, Betül
Kaseb, Mohamed O.
Kasseb, Osama O.
Gocio, Michelle York
Tu, Peter Tsu-Man
Kaseb, Ahmed O.
MetadataShow full item record
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
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.
WoS Q KategorisiQ2
- Makale Koleksiyonu 
- PubMed İndeksli Yayınlar Koleksiyonu 
- Scopus İndeksli Yayınlar Koleksiyonu 
- WoS İndeksli Yayınlar Koleksiyonu