Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus
Keywords
Abstract
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.
Dates
| Last Verified: | 03/31/2020 |
| First Submitted: | 03/22/2020 |
| Estimated Enrollment Submitted: | 03/23/2020 |
| First Posted: | 03/25/2020 |
| Last Update Submitted: | 04/17/2020 |
| Last Update Posted: | 04/20/2020 |
| Actual Study Start Date: | 04/14/2020 |
| Estimated Primary Completion Date: | 12/14/2020 |
| Estimated Study Completion Date: | 01/14/2021 |
Condition or disease
Intervention/treatment
Dietary Supplement: Natural Honey Group
Other: Standard Care
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Natural Honey Group Natural Honey
1gm/kg/day divided into 2 to 3 doses for 14 days in addition to standard care | Dietary Supplement: Natural Honey Group Natural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube. |
| Active Comparator: 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. |
Eligibility Criteria
| Ages Eligible for Study | 5 Years To 5 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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. |
Outcome
Primary Outcome Measures
1. Rate of recovery from positive to negative swaps [14 days]
2. Fever to normal temperature in days [14 days]
3. Resolution of lung inflammation in CT or X ray [30 days]
Secondary Outcome Measures
1. 30 days mortality rate [30 days]
2. Number of days till reaching negative swab results [30 days]
