tetano
Editor, Senior Moderator
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[SUP] 1 [/SUP], Yasir Ahmed[SUP] 2 [/SUP], Mehmet Kocak[SUP] 3 [/SUP], Enrique Villa[SUP] 4 [/SUP], Cesar Barrera[SUP] 2 [/SUP], Mariya Mohiuddin[SUP] 2 [/SUP], Raul Fortunet[SUP] 1 [/SUP], Emmanuel Iyoha[SUP] 5 [/SUP], Deborah Bates[SUP] 5 [/SUP], Chinedu Okpalor[SUP] 5 [/SUP], Ola Agbosasa[SUP] 5 [/SUP], Karim Mohammed[SUP] 5 [/SUP], Stephen Pondell[SUP] 6 [/SUP], Amr Mohamed[SUP] 7 [/SUP], Yehia I Mohamed[SUP] 8 [/SUP], Betul Gok Yavuz[SUP] 8 [/SUP], Mohamed O Kaseb[SUP] 9 [/SUP], Osama O Kasseb[SUP] 9 [/SUP], Michelle York Gocio[SUP] 9 [/SUP], Peter Tsu-Man Tu[SUP] 10 [/SUP], Dan Li[SUP] 11 [/SUP], Jianming Lu[SUP] 12 13 [/SUP], Abdulhafez Selim[SUP] 14 [/SUP], Qing Ma[SUP] 11 [/SUP], Ahmed O Kaseb[SUP] 8 [/SUP]
Affiliations
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[SUP]+[/SUP] (p = 0.042) and helper CD4[SUP]+[/SUP] (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.
. 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[SUP] 1 [/SUP], Yasir Ahmed[SUP] 2 [/SUP], Mehmet Kocak[SUP] 3 [/SUP], Enrique Villa[SUP] 4 [/SUP], Cesar Barrera[SUP] 2 [/SUP], Mariya Mohiuddin[SUP] 2 [/SUP], Raul Fortunet[SUP] 1 [/SUP], Emmanuel Iyoha[SUP] 5 [/SUP], Deborah Bates[SUP] 5 [/SUP], Chinedu Okpalor[SUP] 5 [/SUP], Ola Agbosasa[SUP] 5 [/SUP], Karim Mohammed[SUP] 5 [/SUP], Stephen Pondell[SUP] 6 [/SUP], Amr Mohamed[SUP] 7 [/SUP], Yehia I Mohamed[SUP] 8 [/SUP], Betul Gok Yavuz[SUP] 8 [/SUP], Mohamed O Kaseb[SUP] 9 [/SUP], Osama O Kasseb[SUP] 9 [/SUP], Michelle York Gocio[SUP] 9 [/SUP], Peter Tsu-Man Tu[SUP] 10 [/SUP], Dan Li[SUP] 11 [/SUP], Jianming Lu[SUP] 12 13 [/SUP], Abdulhafez Selim[SUP] 14 [/SUP], Qing Ma[SUP] 11 [/SUP], Ahmed O Kaseb[SUP] 8 [/SUP]
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[SUP]+[/SUP] (p = 0.042) and helper CD4[SUP]+[/SUP] (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.