We found a match
Your institution may have rights to this item. Sign in to continue.
- Title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2.
- Authors
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
- 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.
- Subjects
SARS-CoV-2; T cells; ORAL drug administration; CYTOTOXIC T cells; ORAL medication; SAFETY; STATISTICAL significance
- Publication
Pathogens, 2022, Vol 11, Issue 5, p551
- ISSN
2076-0817
- Publication type
Article
- DOI
10.3390/pathogens11050551