A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2.
In: Pathogens (Basel, Switzerland), Jg. 11 (2022-05-07), Heft 5
Online
academicJournal
Zugriff:
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.
Titel: |
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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Autor/in / Beteiligte Person: | Bencheqroun, H ; Ahmed, Y ; Kocak, M ; Villa, E ; Barrera, C ; Mohiuddin, M ; Fortunet, R ; Iyoha, E ; Bates, D ; Okpalor, C ; Agbosasa, O ; Mohammed, K ; Pondell, S ; Mohamed, A ; Mohamed, YI ; Gok Yavuz, B ; Kaseb, MO ; Kasseb, OO ; Gocio, MY ; Tu, PT ; Li, D ; Lu, J ; Selim, A ; Ma, Q ; Kaseb, AO |
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Zeitschrift: | Pathogens (Basel, Switzerland), Jg. 11 (2022-05-07), Heft 5 |
Veröffentlichung: | Basel, Switzerland : MDPI AG, 2012-, 2022 |
Medientyp: | academicJournal |
ISSN: | 2076-0817 (print) |
DOI: | 10.3390/pathogens11050551 |
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