Oral nano-curcumin formulation efficacy in management of mild to moderate hospitalized coronavirus disease-19 patients: An open label nonrandomized clinical trial
Saber-Moghaddam et al.,
Oral nano-curcumin formulation efficacy in management of mild to moderate hospitalized coronavirus disease-19..,
Phytotherapy Research, doi:10.1002/ptr.7004
Small prospective nonrandomized trial with 41 patients, 21 treated with curcumin, showing lower disease progression and faster recovery with treatment. IRCT20200408046990N1.
risk of progression, 94.3% lower, RR 0.06, p = 0.001, treatment 0 of 21 (0.0%), control 8 of 20 (40.0%), NNT 2.5, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
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risk of no recovery, 38.4% lower, RR 0.62, p = 0.04, treatment 11 of 21 (52.4%), control 17 of 20 (85.0%), NNT 3.1.
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hospitalization time, 44.8% lower, relative time 0.55, p < 0.001, treatment 21, control 20.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Saber-Moghaddam et al., 3 Jan 2021, prospective, Iran, peer-reviewed, 9 authors.
Abstract: Received: 18 August 2020
Revised: 14 December 2020
Accepted: 14 December 2020
DOI: 10.1002/ptr.7004
RESEARCH ARTICLE
Oral nano-curcumin formulation efficacy in management of
mild to moderate hospitalized coronavirus disease-19 patients:
An open label nonrandomized clinical trial
Niloofar Saber-Moghaddam1
|
Soofia Salari1 |
Sepideh Hejazi2 |
| Saeed Eslami5 | Seyed Mahdi Rezayat6
Zhila Taherzadeh4
Mahmoud Reza Jaafari7,8 | Sepideh Elyasi1
Mahnaz Amini3 |
|
1
Department of Clinical Pharmacy, School of
Pharmacy, Mashhad University of Medical
Sciences, Mashhad, Iran
2
Rheumatic Diseases Research Center, School
of Medicine, Mashhad University of Medical
Sciences, Mashhad, Iran
3
Curcumin is proposed as a potential treatment option for coronavirus disease-19
(COVID-19) by inhibiting the virus entrance, encapsulation and replication, and modulating various cellular signaling pathways. In this open-label nonrandomized clinical
trial, efficacy of nano-curcumin oral formulation has been evaluated in hospitalized
Department of Internal Medicine, Mashhad
University of Medical Sciences, Mashhad, Iran
patients with mild–moderate COVID-19. Forty-one patients who fulfilled the inclu-
4
sion criteria were allocated to nano-curcumin (n = 21) group (Sinacurcumin soft gel,
Targeted Drug Delivery Research Center,
School of Pharmacy, Mashhad University of
Medical Sciences, Mashhad, Iran
5
Department of Medical Informatics, Faculty
of Medicine, Mashhad University of Medical
Sciences, Mashhad, Iran
contains 40 mg curcuminoids as nanomicelles, two capsules twice a day) or control
(n = 20) group, for 2 weeks. Patients' symptoms and laboratory data were assessed at
baseline and during follow-up period. Most of symptoms including fever and chills,
tachypnea, myalgia, and cough resolved significantly faster in curcumin group. More-
6
Department of Pharmacology, School of
Medicine, Tehran University of Medical
Sciences, Tehran, Iran
7
over, SaO2 was significantly higher in treatment group after 2, 4, 7, and 14 days of
follow-up and lymphocyte count after 7 and 14 days. Duration of supplemental O2
Nanotechnology Research Center,
Pharmaceutical Technology Institute, Mashhad
University of Medical Sciences, Mashhad, Iran
use and hospitalization was also meaningfully shorter in treatment group. It is also
8
Department of Pharmaceutical
Nanotechnology, School of Pharmacy,
Mashhad University of Medical Sciences,
Mashhad, Iran
of infection during follow-up period, but it occurred in 40% of control group. Oral
Correspondence
Sepideh Elyasi, Department of Clinical
Pharmacy, School of Pharmacy, Mashhad
University of Medical Sciences, Mashhad, Iran.
Email: elyasis@mums.ac.ir
noteworthy to mention that no patient in treatment group experienced deterioration
curcumin nano-formulation can significantly improve recovery time in hospitalized
COVID-19 patients. Further randomized placebo controlled trials with larger sample
size are recommended.
KEYWORDS
antiinflammatory, clinical response, COVID-19, curcumin
Funding information
Research Council of Mashhad University of
Medical Sciences
1
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I N T RO DU CT I O N
cause of COVID-19 mortality, mostly due to cytokine storm syndrome
(Mehta et al., 2020; Ruan, Yang, Wang, Jiang, & Song, 2020). Actually,
Coronavirus disease 2019 (COVID-19)-induced pneumonia became
high cytokine level including IL-2, IL-7, granulocyte colony–stimulating
an international concern, which led to the first pandemic of the..
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