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Article

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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RESPIRE Clinical Research, Palm Springs, CA 92262, USA
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United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA
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Department of Biostatistics and Medical Informatics, International School of Medicine, Istanbul Medipol University, 34810 Istanbul, Turkey
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L&A Morales Healthcare, Inc., Miami, FL 33012, USA
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Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA
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Chemistry, Manufacturing and Controls Department, Novatek Pharmaceuticals, Inc., Houston, TX 77054, USA
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UH Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA
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Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
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Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA
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Law Offices of Peter Tu LLC, Plainsboro, NJ 08536, USA
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Department of Hematopoietic Biology and Malignancy, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
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Department of Biochemistry and Molecular and Cellular Biology, Georgetown University School of Medicine, Washington, DC 20007, USA
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Codex BioSolutions Inc., Rockville, MD 20852, USA
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Philadelphia College of Osteopathic Medicine (PCOM), Philadelphia, PA 19131, USA
*
Authors to whom correspondence should be addressed.
Academic Editor: Anna Honko
Pathogens 2022, 11(5), 551; https://doi.org/10.3390/pathogens11050551 (registering DOI)
Received: 22 April 2022 / Revised: 4 May 2022 / Accepted: 6 May 2022 / Published: 7 May 2022
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 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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