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All Studies   Meta Analysis    Recent:   

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
May 2022  
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Hospitalization 69% Improvement Relative Risk Time to sustained clinical.. 9% Time to sustained clin.. (b) 35% Viral clearance 43% Nigella Sativa  Bencheqroun et al.  EARLY TREATMENT  DB RCT 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 sig. c19early.org Bencheqroun et al., Pathogens, May 2022 Favorsnigella sativa Favorscontrol 0 0.5 1 1.5 2+
12th treatment shown to reduce risk in January 2021
 
*, now with p = 0.00016 from 14 studies.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,400+ studies for 81 treatments. c19early.org
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.
This PaperNigella SativaAll
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, Yasir Ahmed, Mehmet Kocak, Enrique Villa, Cesar Barrera, Mariya Mohiuddin, Raul Fortunet, Emmanuel Iyoha, Deborah Bates, Chinedu Okpalor, Ola Agbosasa, Karim Mohammed, Stephen Pondell, Amr Mohamed, Yehia I Mohamed, Betul Gok Yavuz, Mohamed O Kaseb, Osama O Kasseb, Michelle York Gocio, Peter Tsu-Man Tu, Dan Li, Jianming Lu, Abdulhafez Selim, Qing Ma, Ahmed O Kaseb
Pathogens, doi:10.3390/pathogens11050551
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.
method and compared between the two arms of the study by the log-rank test. Median time-to-SCR was estimated through the Kaplan-Meier product-limit method. In comparing viral load (VL) distribution between the two arms of the study crosssectionally, the Wilcoxon-Mann-Whitney test, a non-parametric alternative to the twosample t-test, was used, where any measurement provided as '>25,000' was conservatively considered as 25,000 and the VL measurements of SARS-CoV-2-negative samples were considered as zero. For longitudinal modeling of VL, a random coefficient modeling approach through the SAS MIXED procedure was used with individual specific intercepts and slope estimates. The same approach was used for longitudinal individual symptom burden assessments, where both linear and quadratic changes over time were added to the model. We added symptom scores to obtain a measure of total symptom burden from days 1-14; similarly, subdomain scores were obtained as unweighted additions of relevant symptom scores. In all these longitudinal models, the primary interest was to investigate whether there was a significant change in these markers over time and whether such change depended on the treatment arm. For the T lymphocytes subsets, compared on day 1, day 7, and day 14, the abovementioned non-parametric testing approach was also used. As the flow-cytometry analysis was exploratory in nature, no multiplicity correction was carried out. Consequently, the widths of the intervals have..
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