A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2

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. View Full-Text

Keywords: COVID-19; TQ Formula; pandemic; coronavirus; SARS-CoV-2

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MDPI and ACS Style

Bencheqroun, H.; Ahmed, Y.; Kocak, M.; Villa, E.; Barrera, C.; Mohiuddin, M.; Fortunet, R.; Iyoha, E.; Bates, D.; Okpalor, C.; Agbosasa, O.; Mohammed, K.; Pondell, S.; Mohamed, A.; Mohamed, Y.I.; Gok Yavuz, B.; Kaseb, M.O.; Kasseb, O.O.; Gocio, M.Y.; Tu, P.T.-M.; Li, D.; Lu, J.; Selim, A.; Ma, Q.; Kaseb, A.O. 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 2022, 11, 551. https://doi.org/10.3390/pathogens11050551

AMA Style

Bencheqroun H, Ahmed Y, Kocak M, Villa E, Barrera C, Mohiuddin M, Fortunet R, Iyoha E, Bates D, Okpalor C, Agbosasa O, Mohammed K, Pondell S, Mohamed A, Mohamed YI, Gok Yavuz B, Kaseb MO, Kasseb OO, Gocio MY, Tu PT-M, Li D, Lu J, Selim A, Ma Q, Kaseb AO. 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. 2022; 11(5):551. https://doi.org/10.3390/pathogens11050551

Chicago/Turabian Style

Bencheqroun, Hassan, Yasir Ahmed, Mehmet Kocak, Enrique Villa, Cesar Barrera, Mariya Mohiuddin, Raul Fortunet, Emmanuel Iyoha, Deborah Bates, Chinedu Okpalor, Ola Agbosasa, Karim Mohammed, Stephen Pondell, Amr Mohamed, Yehia I. Mohamed, Betul Gok Yavuz, Mohamed O. Kaseb, Osama O. Kasseb, Michelle Y. Gocio, Peter T.-M. Tu, Dan Li, Jianming Lu, Abdulhafez Selim, Qing Ma, and Ahmed O. Kaseb. 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, no. 5: 551. https://doi.org/10.3390/pathogens11050551

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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

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