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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
| Content Provider | MDPI |
|---|---|
| Author | 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. Yavuz, Betul Gok Kaseb, Mohamed O. Kasseb, Osama O. Tu, Peter Tsu-Man Li, Dan Lu, Jianming Selim, Abdulhafez Ma, Qing Kaseb, Ahmed O. |
| Copyright Year | 2022 |
| Description | 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. |
| Starting Page | 551 |
| e-ISSN | 20760817 |
| DOI | 10.3390/pathogens11050551 |
| Journal | Pathogens |
| Issue Number | 5 |
| Volume Number | 11 |
| Language | English |
| Publisher | MDPI |
| Publisher Date | 2022-05-07 |
| Access Restriction | Open |
| Subject Keyword | Pathogens Integrative and Complementary Medicine Covid-19 Tq Formula Pandemic Coronavirus Sars-cov-2 |
| Content Type | Text |
| Resource Type | Article |
