Clinical trial NCT04323345: Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: COVID-19
Keywords: Coronavirus
Natural Honey
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2020-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Meeting the criteria for diagnosis of COVID-19, either clinically or as confirmed by positive swap.

Exclusion Criteria:

* Children below 5 years old. Severely ill patients with either terminal disease. Nil per os (NPO) patients with contraindication to nasogastric tube feeding.

Primary outcomes:
measure: Rate of recovery from positive to negative swaps
timeFrame: 14 days
measure: Fever to normal temperature in days
timeFrame: 14 days
measure: Resolution of lung inflammation in CT or X ray
timeFrame: 30 days
Secondary outcomes:
measure: 30 days mortality rate
timeFrame: 30 days
measure: Number of days till reaching negative swab results
timeFrame: 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud Tantawy
Study officials:
affiliation: Misr University for Science and Technology
name: Mahmoud Tantawy, MD
role: STUDY_CHAIR
References: