A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2
Hassan Bencheqroun,
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 York Gocio,
Peter Tsu-Man Tu,
Dan Li,
Jianming Lu,
Abdulhafez Selim,
Qing Ma,
Ahmed O. Kaseb
Affiliations
Hassan Bencheqroun
RESPIRE Clinical Research, Palm Springs, CA 92262, USA
Yasir Ahmed
United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA
Mehmet Kocak
Department of Biostatistics and Medical Informatics, International School of Medicine, Istanbul Medipol University, 34810 Istanbul, Turkey
Enrique Villa
L&A Morales Healthcare, Inc., Miami, FL 33012, USA
Cesar Barrera
United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA
Mariya Mohiuddin
United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA
Raul Fortunet
RESPIRE Clinical Research, Palm Springs, CA 92262, USA
Emmanuel Iyoha
Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA
Deborah Bates
Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA
Chinedu Okpalor
Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA
Ola Agbosasa
Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA
Karim Mohammed
Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA
Stephen Pondell
Chemistry, Manufacturing and Controls Department, Novatek Pharmaceuticals, Inc., Houston, TX 77054, USA
Amr Mohamed
UH Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA
Yehia I. Mohamed
Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
Betul Gok Yavuz
Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
Mohamed O. Kaseb
Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA
Osama O. Kasseb
Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA
Michelle York Gocio
Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA
Peter Tsu-Man Tu
Law Offices of Peter Tu LLC, Plainsboro, NJ 08536, USA
Dan Li
Department of Hematopoietic Biology and Malignancy, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
Jianming Lu
Department of Biochemistry and Molecular and Cellular Biology, Georgetown University School of Medicine, Washington, DC 20007, USA
Abdulhafez Selim
Philadelphia College of Osteopathic Medicine (PCOM), Philadelphia, PA 19131, USA
Qing Ma
Department of Hematopoietic Biology and Malignancy, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
Ahmed O. Kaseb
Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA
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 + (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.