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0 0.5 1 1.5 2+ Hospitalization 69% Improvement Relative Risk Time to sustained clinical.. 9% Time to sustained clini.. (b) 35% Viral clearance 43% c19early.org/ns Bencheqroun et al. Nigella Sativa for COVID-19 RCT EARLY Is early treatment with nigella sativa beneficial for COVID-19? Double-blind RCT 52 patients in the USA (May - September 2021) Lower hospitalization (p=0.44) and improved viral clearance (p=0.31), not stat. sig. Bencheqroun et al., Pathogens, doi:10.3390/pathogens11050551 Favors nigella sativa Favors control
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of ThymoQuinone Formula (TQF) for Treating Outpatient SARS-CoV-2
Bencheqroun et al., Pathogens, doi:10.3390/pathogens11050551
Bencheqroun et al., A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of.., Pathogens, doi:10.3390/pathogens11050551
May 2022   Source   PDF  
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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.
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).
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.
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.
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.
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.
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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, * 1 2 3 4 5 6 Citation: Bencheqroun, H.; Ahmed, Y.; Kocak, M.; Villa, E.; Barrera, C.; 7 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 11 (TQF) for Treating Outpatient SARS-CoV-2. Pathogens 2022, 11, 551. 12 https://doi.org/10.3390/ pathogens11050551 13 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 Publisher’s Note: MDPI stays neutral with regard to jurisdictional claims in published maps and institutional affiliations. Copyright: © 2022 by the authors. Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the..
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