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All Studies   Meta Analysis    Recent:   

NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial

Gérain et al., Frontiers in Nutrition, doi:10.3389/fnut.2023.1137407, NCT04844658
Jun 2023  
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Mortality 67% Improvement Relative Risk Death/ICU 91% Ventilation 89% ICU admission 89% Discharge, day 14 73% Discharge, day 7 59% Hospitalization time 38% WHO score 50% Curcumin  Gérain et al.  LATE TREATMENT  RCT Is late treatment with curcumin + quercetin beneficial for COVID-19? RCT 49 patients in Belgium (April - October 2021) Lower death/ICU (p=0.022) and improved recovery (p=0.04) c19early.org Gérain et al., Frontiers in Nutrition, Jun 2023 Favorscurcumin Favorscontrol 0 0.5 1 1.5 2+
Curcumin for COVID-19
15th treatment shown to reduce risk in February 2021
 
*, now with p = 0.0000000096 from 27 studies.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
4,800+ studies for 95 treatments. c19early.org
RCT 49 hospitalized COVID-19 patients, 25 treated with curcumin and quercetin, shower lower mortality/ICU admission and improved recovery with treatment. All patients received vitamin D.
336mg curcumin, 520mg quercetin, and 18μg vitamin D3 daily for 14 days. The control arm received 20μg vitamin D3 daily. Baseline fever favored treatment while vaccination favored control.
This is the 19th of 21 COVID-19 RCTs for curcumin, which collectively show efficacy with p=0.0000022.
This is the 25th of 27 COVID-19 controlled studies for curcumin, which collectively show efficacy with p=0.0000000096 (1 in 104 million).
Study covers curcumin and quercetin.
risk of death, 67.1% lower, RR 0.33, p = 0.49, treatment 0 of 25 (0.0%), control 1 of 24 (4.2%), NNT 24, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7.
risk of death/ICU, 91.1% lower, RR 0.09, p = 0.02, treatment 0 of 25 (0.0%), control 5 of 24 (20.8%), NNT 4.8, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7.
risk of mechanical ventilation, 89.1% lower, RR 0.11, p = 0.05, treatment 0 of 25 (0.0%), control 4 of 24 (16.7%), NNT 6.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7.
risk of ICU admission, 89.1% lower, RR 0.11, p = 0.05, treatment 0 of 25 (0.0%), control 4 of 24 (16.7%), NNT 6.0, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm), day 7.
risk of no hospital discharge, 72.6% lower, RR 0.27, p = 0.07, treatment 2 of 25 (8.0%), control 7 of 24 (29.2%), NNT 4.7, day 14.
risk of no hospital discharge, 58.9% lower, RR 0.41, p = 0.02, treatment 6 of 25 (24.0%), control 14 of 24 (58.3%), NNT 2.9, day 7.
hospitalization time, 37.5% lower, relative time 0.62, p = 0.008, treatment median 5.0 IQR 4.0 n=25, control median 8.0 IQR 6.0 n=24.
relative WHO score, 50.0% better, RR 0.50, p = 0.04, treatment 22, control 24, day 7.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Gérain et al., 22 Jun 2023, Randomized Controlled Trial, Belgium, peer-reviewed, 8 authors, study period 1 April, 2021 - 29 October, 2021, this trial uses multiple treatments in the treatment arm (combined with quercetin) - results of individual treatments may vary, trial NCT04844658 (history). Contact: melanie.uebelhoer@artialis.com.
This PaperCurcuminAll
NASAFYTOL® supplementation in adults hospitalized with COVID-19 infection: results from an exploratory open-label randomized controlled trial
Jean Gérain, Melanie Uebelhoer, Bérénice Costes, Julie Herman, Sandra Pietri, Anne-Françoise Donneau, Justine Monseur, Yves Henrotin
Frontiers in Nutrition, doi:10.3389/fnut.2023.1137407
Objectives: The effect and safety of Nasafytol ® , a food supplement combining curcumin, quercetin, and Vitamin D, on hospitalized COVID-19-positive patients as support to standard of care were to be assessed. Methods: This exploratory, open-label, randomized, controlled trial was carried out among hospitalized adults with COVID-19 infection. Participants were randomly assigned to receive Nasafytol ® or Fultium ® control. The improvement of the clinical condition and occurrence of (serious) adverse events were evaluated. The study was registered on clincaltrials.gov with the identifier NCT04844658. Results: Twenty-five patients received Nasafytol ® , and 24 received Fultium ® . Demographic characteristics were well balanced between the groups. On day 14 (or at hospital leave if < 14 days), no difference was observed between groups regarding their clinical condition, fever, or the need of oxygen therapy. At day 7, however, 19 participants had been discharged from the hospital in the Nasafytol ® arm compared to 10 participants in the Fultium ® arm. No participants were transferred to the ICU or died in the Nasafytol ® arm, vs. 4 transfers and 1 death in the Fultium ® arm. The clinical condition of participants in the Nasafytol ® arm had improved, as evidenced by a decrease in the COVID-19 WHO score. Interestingly, five SAEs occurred with Fultium ® , while no SAE was observed with Nasafytol ® . Conclusion: Supplementation with Nasafytol ® , in addition to standard-of-care treatment, led to a faster discharge from the hospital, improved clinical conditions of participants, and a reduced risk of serious outcomes, including transfer to the intensive care unit or death, in patients hospitalized with COVID-19.
Ethics statement The studies involving human participants were reviewed and approved by Ethics Committee of the University Hospital of Brussels (Erasme-ULB) in Belgium (Comité d'Ethique Hospitalo-Facultaire Erasme-ULB) (protocol code B4062020000305 on January 15, 2021). The patients/participants provided their written informed consent to participate in this study. Author contributions BC and YH: conceptualization. JG, BC, JH, and YH: methodology. A-FD and JM: statistical analysis. JG: investigation. MU and YH: writing-original draft preparation. JG, BC, JH, SP, A-FD, and JM: writing-review and editing. MU, BC, and JH: project administration. JG, MU, BC, JH, SP, A-FD, JM, and YH had full access to all the data in the study and had final responsibility for the decision to submit for publication. BC, JH, and YH accessed and verified the data. All authors contributed to the article and approved the submitted version. Conflict of interest YH is the founder and president of Artialis SA, a spin-off company of the University of Liège. YH has also received consulting and speaker fees from Tilman SA, Nestlé, Laboratoire Expanscience, Heel, Publisher's note All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed..
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Dietary Reference ' 'Intakes for Calcium and Vitamin DDietary Reference Intakes for Calcium ' 'and Vitamin D', 'author': 'Ross', 'year': '2011'}], 'container-title': 'Frontiers in Nutrition', 'original-title': [], 'link': [ { 'URL': 'https://www.frontiersin.org/articles/10.3389/fnut.2023.1137407/full', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2023, 6, 23]], 'date-time': '2023-06-23T16:46:27Z', 'timestamp': 1687538787000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.frontiersin.org/articles/10.3389/fnut.2023.1137407/full'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2023, 6, 22]]}, 'references-count': 33, 'alternative-id': ['10.3389/fnut.2023.1137407'], 'URL': 'http://dx.doi.org/10.3389/fnut.2023.1137407', 'relation': {}, 'ISSN': ['2296-861X'], 'subject': ['Nutrition and Dietetics', 'Endocrinology, Diabetes and Metabolism', 'Food Science'], 'container-title-short': 'Front. Nutr.', 'published': {'date-parts': [[2023, 6, 22]]}}
Late treatment
is less effective
Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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