Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus
Primary Purpose
COVID-19
Status
Unknown status
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Natural Honey
Standard Care
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19 focused on measuring Coronavirus, Natural Honey
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.
Sites / Locations
- Mahmoud TantawyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Natural Honey Group
Standard Care
Arm Description
Natural Honey 1gm/kg/day divided into 2 to 3 doses for 14 days in addition to standard care
Current standard care including supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.
Outcomes
Primary Outcome Measures
Rate of recovery from positive to negative swaps
Percentage of patients turned from positive to negative swaps at day 14
Fever to normal temperature in days
Number of days till no fever
Resolution of lung inflammation in CT or X ray
Number of days till lungs recovery in chest X ray or CT
Secondary Outcome Measures
30 days mortality rate
mortality rate in each group at 30 days
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
Full Information
NCT ID
NCT04323345
First Posted
March 23, 2020
Last Updated
April 18, 2020
Sponsor
Misr University for Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT04323345
Brief Title
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
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 15, 2020 (Anticipated)
Primary Completion Date
December 15, 2020 (Anticipated)
Study Completion Date
January 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Misr University for Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Coronavirus, Natural Honey
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Natural Honey Group
Arm Type
Experimental
Arm Description
Natural Honey
1gm/kg/day divided into 2 to 3 doses for 14 days in addition to standard care
Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Current standard care including supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.
Intervention Type
Dietary Supplement
Intervention Name(s)
Natural Honey
Intervention Description
Natural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube.
Intervention Type
Other
Intervention Name(s)
Standard Care
Intervention Description
Supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.
Primary Outcome Measure Information:
Title
Rate of recovery from positive to negative swaps
Description
Percentage of patients turned from positive to negative swaps at day 14
Time Frame
14 days
Title
Fever to normal temperature in days
Description
Number of days till no fever
Time Frame
14 days
Title
Resolution of lung inflammation in CT or X ray
Description
Number of days till lungs recovery in chest X ray or CT
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30 days mortality rate
Description
mortality rate in each group at 30 days
Time Frame
30 days
Title
Number of days till reaching negative swab results
Description
Number of days from initiation of intervention till changing of the swap test result from positive to negative
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mahmoud Tantawy, MD
Organizational Affiliation
Misr University for Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Mahmoud Tantawy
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahmoud Tantawy, MD
Phone
+201221865587
Email
drmtantawy@yahoo.com
First Name & Middle Initial & Last Name & Degree
Mahmoud Tantawy, MD
Email
drmtantawy@icloud.com
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/22419319
Description
Honey for acute cough in children
URL
https://www.nice.org.uk/guidance/ng120/chapter/Summary-of-the-evidence
Description
NICE Guidelines (NG120)
URL
https://doi.org/10.1155/2019/2464507
Description
Antibacterial potency of Honey
URL
https://link.springer.com/article/10.1007%2FBF02850228
Description
The scolicidal effects of honey
URL
https://doi.org/10.1097/MJT.0b013e318293b09b
Description
Antimicrobial properties of honey
URL
https://www.transbiomedicine.com/translational-biomedicine/in-vitro-antiviral-activity-of-honey-against-varicella-zoster-virus-vzv-a-translational-medicine-study-for-potential-remedy-for-shingles.php?aid=2493
Description
In vitro antiviral activity of honey against varicella zoster virus (VZV): A translational medicine study for potential remedy for shingles
URL
https://www.woundsresearch.com/article/antiviral-activities-honey-royal-jelly-and-acyclovir-against-hsv-1
Description
Antiviral Activities of Honey, Royal Jelly, and Acyclovir Against HSV-1
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4837971/
Description
Therapeutic Manuka Honey: No Longer So Alternative
URL
https://www.ncbi.nlm.nih.gov/pubmed/?term=pieper+b+honey+based
Description
Honey-based dressings and wound care: an option for care in the United States
Learn more about this trial
Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus
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