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    A randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of thymoquinone formula (TQF) for treating outpatient SARS-CoV-2
    (MDPI, 2022) Bencheqroun, Hassan; Ahmed, Yasir; Koçak, Mehmet; Villa, Enrique; Barrera, Cesar; Mohiuddin, Mariya; Fortunet, Raul; Iyoha, Emmanuel; Bates, Deborah; Okpalor, Chinedu; Agbosasa, Ola; Mohammed, Karim; Pondell, Stephen; Mohamed, Amr; Mohamed, Yehia I.; Gök Yavuz, Betül; Kaseb, Mohamed O.; Kasseb, Osama O.; Gocio, Michelle York; Tu, Peter Tsu-Man; Li, Dan; Lu, Jianming; Selim, Abdulhafez; Ma, Qing; Kaseb, Ahmed O.
    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.