Pathogens . 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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Pathogens


. 2022 May 7;11(5):551.
doi: 10.3390/pathogens11050551.
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 ¹ , Yasir Ahmed ² , Mehmet Kocak ³ , Enrique Villa ⁴ , Cesar Barrera ² , Mariya Mohiuddin ² , Raul Fortunet ¹ , Emmanuel Iyoha ⁵ , Deborah Bates ⁵ , Chinedu Okpalor ⁵ , Ola Agbosasa ⁵ , Karim Mohammed ⁵ , Stephen Pondell ⁶ , Amr Mohamed ⁷ , Yehia I Mohamed ⁸ , Betul Gok Yavuz ⁸ , Mohamed O Kaseb ⁹ , Osama O Kasseb ⁹ , Michelle York Gocio ⁹ , Peter Tsu-Man Tu ¹⁰ , Dan Li ¹¹ , Jianming Lu ^{12 13} , Abdulhafez Selim ¹⁴ , Qing Ma ¹¹ , Ahmed O Kaseb ⁸



Affiliations

• PMID: 35631072
• DOI: 10.3390/pathogens11050551

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 (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.

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