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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.
Bencheqroun, Hassan; Ahmed, Yasir; Kocak, 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; Gok Yavuz, Betul; Kaseb, Mohamed O; Kasseb, Osama O; Gocio, Michelle York; Tu, Peter Tsu-Man; Li, Dan; Lu, Jianming; Selim, Abdulhafez; Ma, Qing; Kaseb, Ahmed O.
  • Bencheqroun H; RESPIRE Clinical Research, Palm Springs, CA 92262, USA.
  • Ahmed Y; United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA.
  • Kocak M; Department of Biostatistics and Medical Informatics, International School of Medicine, Istanbul Medipol University, 34810 Istanbul, Turkey.
  • Villa E; L&A Morales Healthcare, Inc., Miami, FL 33012, USA.
  • Barrera C; United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA.
  • Mohiuddin M; United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA.
  • Fortunet R; RESPIRE Clinical Research, Palm Springs, CA 92262, USA.
  • Iyoha E; Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA.
  • Bates D; Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA.
  • Okpalor C; Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA.
  • Agbosasa O; Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA.
  • Mohammed K; Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA.
  • Pondell S; Chemistry, Manufacturing and Controls Department, Novatek Pharmaceuticals, Inc., Houston, TX 77054, USA.
  • Mohamed A; UH Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA.
  • Mohamed YI; Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
  • Gok Yavuz B; Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
  • Kaseb MO; Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA.
  • Kasseb OO; Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA.
  • Gocio MY; Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA.
  • Tu PT; Law Offices of Peter Tu LLC, Plainsboro, NJ 08536, USA.
  • Li D; Department of Hematopoietic Biology and Malignancy, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
  • Lu J; Department of Biochemistry and Molecular and Cellular Biology, Georgetown University School of Medicine, Washington, DC 20007, USA.
  • Selim A; Codex BioSolutions Inc., Rockville, MD 20852, USA.
  • Ma Q; Philadelphia College of Osteopathic Medicine (PCOM), Philadelphia, PA 19131, USA.
  • Kaseb AO; Department of Hematopoietic Biology and Malignancy, University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
Pathogens ; 11(5)2022 May 07.
Article in English | MEDLINE | ID: covidwho-1862868
ABSTRACT
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 (11 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.
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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Variants Language: English Year: 2022 Document Type: Article Affiliation country: Pathogens11050551

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Cohort study / Experimental Studies / Observational study / Prognostic study / Randomized controlled trials Topics: Variants Language: English Year: 2022 Document Type: Article Affiliation country: Pathogens11050551