COVID-19 Clinical Trial
Official title:
The Efficacy of Natural Honey in Patients Infected With Novel Coronavirus (COVID-19) : A Randomized, Controlled ,Single Masked , Investigator Initiated, Multi-center Trial
The novel coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) has been discovered recently in December 2019 from wuhan city in China to spread in more than 40 countries allover the world. This disease has gain the attention of all nations after it has been stated as a pandemic by the World Health Organization (WHO) in March 12, 2020. Currently no treatment has been proved to be efficient in the treatment of infected patients by COVID-19. Natural honey has been demonstrated as potent antimicrobial in many research investigations and has been considered a good alternative for antiviral drugs for the treatment of some viral infections. The investigators aim to study the efficacy of natural honey in the treatment of COVID-19 patients in this randomized , multicenter, controlled trial, comparing honey in one arm to standard care in the other arm.
The (SARS CoV-2) virus is spreading globally, threatening all healthcare systems. Many
healthcare systems and organizations are using different protocols and measures to fight the
COVID-19. Hydroxychloroquine, lopinavir and other antiviral medications are currently under
research investigations. Natural honey has been well known for its high health properties in
diabetes, nutrition, dyslipidemia, skin lesions and it got FDA approval for topical wound
treatment in 2007 as the most potent antimicrobial agent. Honey has been previously
considered as an alternative for acyclovir in the treatment of herpes simplex virus 1 (HSV-1)
and it also demonstrated for its significant antiviral effect against varicella zoster virus
(VZV). Many studies have demonstrated the broad spectrum antimicrobial effect of honey as an
antibacterial, anti fungal, antiviral and antimycobacterial. The National Institute for
Health and Care Excellence (NICE) and the Public Health England (PHE) guidelines recommended
honey as a first line of treatment for acute cough caused by upper respiratory tract
infection which is currently a cornerstone symptom in COVID-19 infectious disease. Moreover,
natural honey should no longer be used as "alternative" and deserves to gain more attention
by scientists and researchers. The aim of this trial is to study the efficacy of natural
honey in treatment of patients infected with COVID-19 in comparison with current standard
care.
Methods:
This will be a randomized , multi center, double armed clinical trial, patients will be
randomly assigned to two groups on 1:1 basis. Natural honey group will include patients
receiving standard care and added intervention in the form of natural honey in a dose of
1gm/kg/day (previously used safely in small studies) divided into 2 to 3 doses for continuous
14 days. The other arm is the arm receiving the standard care according to the center
protocol.
Our primary outcome is days for recovery using the parameters: turning from positive to
negative swaps, days from fever to no fever and lung inflammation recovery in x ray or CT,
our secondary outcome is the 30 days mortality rate. Data will be collected and statistically
managed using STATA blindly from who received the intervention.
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