Pathogens (May 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

  • 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

DOI
https://doi.org/10.3390/pathogens11050551
Journal volume & issue
Vol. 11, no. 5
p. 551

Abstract

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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.

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