Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04323345
• Other study ID #: MUST23032020
• Status: Recruiting
• Phase: Phase 3
• Start date: April 15, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: April 2020
• Source: Misr University for Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: January 15, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Infections
• COVID-19

Intervention

Dietary Supplement:
• Natural Honey
Natural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube.

Other:
• Standard Care
Supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.

Locations

Country	Name	City	State
Egypt	Mahmoud Tantawy	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Misr University for Science and Technology

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of recovery from positive to negative swaps	Percentage of patients turned from positive to negative swaps at day 14	14 days
Primary	Fever to normal temperature in days	Number of days till no fever	14 days
Primary	Resolution of lung inflammation in CT or X ray	Number of days till lungs recovery in chest X ray or CT	30 days
Secondary	30 days mortality rate	mortality rate in each group at 30 days	30 days
Secondary	Number of days till reaching negative swab results	Number of days from initiation of intervention till changing of the swap test result from positive to negative	30 days

External Links

•   Antibacterial potency of Honey
•   Antimicrobial properties of honey
•   Antiviral Activities of Honey, Royal Jelly, and Acyclovir Against HSV-1
•   Honey for acute cough in children
•   Honey, not antibiotics, recommended for coughs
•   Honey-based dressings and wound care: an option for care in the United States
•   In vitro antiviral activity of honey against varicella zoster virus (VZV): A translational medicine study for potential remedy for shingles
•   NICE Guidelines (NG120)
•   The scolicidal effects of honey
•   Therapeutic Manuka Honey: No Longer So Alternative