A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2
et al., Pathogens, doi:10.3390/pathogens11050551
, A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of.., Pathogens, doi:10.3390/pathogens11050551
52 patient RCT in the USA with nigella sativa component thymoquinone, showing improved recovery with treatment. There was a significantly faster decline in the total symptom burden, and a significant increase in CD8+ and helper CD4+ central memory T lymphocytes. The treatment group contained 5 more vaccinated patients and 7 more overweight patients. Authors also present in vitro results showing an inhibitory effect with five SARS-CoV-2 variants including omicron.
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risk of hospitalization, 69.3% lower, RR 0.31, p = 0.44, treatment 0 of 29 (0.0%), control 1 of 23 (4.3%), NNT 23, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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time to sustained clinical response, 9.1% lower, HR 0.91, p = 0.78, treatment 28, control 23, inverted to make HR<1 favor treatment, Kaplan–Meier.
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time to sustained clinical response, 35.5% lower, HR 0.65, p = 0.25, treatment 28, control 23, inverted to make HR<1 favor treatment, Kaplan–Meier, high-risk patients.
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risk of no viral clearance, 43.5% lower, RR 0.57, p = 0.31, treatment 5 of 21 (23.8%), control 8 of 19 (42.1%), NNT 5.5, day 14.
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| Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates |
Bencheqroun et al., 7 May 2022, Double Blind Randomized Controlled Trial, placebo-controlled, USA, peer-reviewed, mean age 45.0, 25 authors, study period 27 May, 2021 - 27 September, 2021.
Contact:
h.bencheqroun@respireresearch.com (corresponding author), r.fortunet@respireresearch.com, yasirahmed.med@gmail.com, cbarrera@ummc.care, mariya@ummc.care, mehmet.kocaktas@gmail.com, evilla@moraleshealthcare.com, emmanueli@tranquilconsulting.com, deborahb@tranquilconsulting.com, chineduo@tranquilconsulting.com, olaa@tranquilconsulting.com, karim@tranquilconsulting.com, spondell@ibtsolutions.us, amr.mohamed@uhhospitals.org, yimohamed@mdanderson.org, bgok@mdanderson.org, mkaseb1@gmail.com, okasseb@hotmail.com, mgocio@novatekpharmaceuticals.com, pt22064@comcast.net, danli@mdanderson.org, qma@mdanderson.org, jimmy_lu@codexbio.com, abdu94@yahoo.com, akaseb@mdanderson.org.
Abstract: pathogens
Article
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 , Steven 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 ,
Abdelhafez Selim 14 , Qing Ma 11 and Ahmed O. Kaseb 8, *
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2
3
4
5
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Citation: Bencheqroun, H.; Ahmed,
Y.; Kocak, M.; Villa, E.; Barrera, C.;
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Mohiuddin, M.; Fortunet, R.; Iyoha,
E.; Bates, D.; Okpalor, C.; et al. A
Randomized, Double-Blind,
8
9
Placebo-Controlled, Multicenter
Study to Evaluate the Safety and
10
Efficacy of ThymoQuinone Formula
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(TQF) for Treating Outpatient
SARS-CoV-2. Pathogens 2022, 11, 551.
12
https://doi.org/10.3390/
pathogens11050551
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14
Academic Editor: Anna Honko
*
RESPIRE Clinical Research, Palm Springs, CA 92262, USA; r.fortunet@respireresearch.com
United Memorial Medical Center, Department of Research and Development, Houston, TX 77091, USA;
yasirahmed.med@gmail.com (Y.A.); cbarrera@ummc.care (C.B.); mariya@ummc.care (M.M.)
Department of Biostatistics and Medical Informatics, International School of Medicine, Istanbul Medipol
University, 34810 Istanbul, Turkey; mehmet.kocaktas@gmail.com
L&A Morales Healthcare, Inc., Miami, FL 33012, USA; evilla@moraleshealthcare.com
Tranquil Clinical and Research Consulting Services, Houston, TX 77598, USA;
emmanueli@tranquilconsulting.com (E.I.); deborahb@tranquilconsulting.com (D.B.);
chineduo@tranquilconsulting.com (C.O.); olaa@tranquilconsulting.com (O.A.);
karim@tranquilconsulting.com (K.M.)
Chemistry, Manufacturing and Controls Department, Novatek Pharmaceuticals, Inc.,
Houston, TX 77054, USA; spondell@ibtsolutions.us
UH Seidman Cancer Center, Case Western Reserve University, Cleveland, OH 44106, USA;
amr.mohamed@uhhospitals.org
Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center,
Houston, TX 77030, USA; yimohamed@mdanderson.org (Y.I.M.); bgok@mdanderson.org (B.G.Y.)
Novatek Pharmaceuticals, Inc., Houston, TX 77598, USA; mkaseb1@gmail.com (M.O.K.);
okasseb@hotmail.com (O.O.K.); mgocio@novatekpharmaceuticals.com (M.Y.G.)
Law Offices of Peter Tu LLC, Plainsboro, NJ 08536, USA; pt22064@comcast.net
Department of Hematopoietic Biology and Malignancy, University of Texas MD Anderson Cancer Center,
Houston, TX 77030, USA; danli@mdanderson.org (D.L.); qma@mdanderson.org (Q.M.)
Department of Biochemistry and Molecular and Cellular Biology, Georgetown University School of Medicine,
Washington, DC 20007, USA; jimmy_lu@codexbio.com
Codex BioSolutions Inc., Rockville, MD 20852, USA
Philadelphia College of Osteopathic Medicine (PCOM), Philadelphia, PA 19131, USA; abdu94@yahoo.com
Correspondence: h.bencheqroun@respireresearch.com (H.B.); akaseb@mdanderson.org (A.O.K.)
Received: 22 April 2022
Accepted: 6 May 2022
Published: 7 May 2022
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