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Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323345
Recruitment Status : Unknown
Verified April 2020 by Mahmoud Ahmed Tantawy, Misr University for Science and Technology.
Recruitment status was:  Recruiting
First Posted : March 26, 2020
Last Update Posted : April 21, 2020
Sponsor:
Information provided by (Responsible Party):
Mahmoud Ahmed Tantawy, Misr University for Science and Technology

Study Description
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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.

Condition or disease Intervention/treatment Phase
COVID-19 Dietary Supplement: Natural Honey Other: Standard Care Phase 3

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.

Study Design
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Study Type : Interventional
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 15, 2020
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Rate of recovery from positive to negative swaps [ Time Frame: 14 days ]
    Percentage of patients turned from positive to negative swaps at day 14

  2. Fever to normal temperature in days [ Time Frame: 14 days ]
    Number of days till no fever

  3. Resolution of lung inflammation in CT or X ray [ Time Frame: 30 days ]
    Number of days till lungs recovery in chest X ray or CT


Secondary Outcome Measures :
  1. 30 days mortality rate [ Time Frame: 30 days ]
    mortality rate in each group at 30 days

  2. Number of days till reaching negative swab results [ Time Frame: 30 days ]
    Number of days from initiation of intervention till changing of the swap test result from positive to negative


Eligibility Criteria
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Ages Eligible for Study:   5 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04323345


Locations
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Egypt
Mahmoud Tantawy Recruiting
Cairo, Egypt
Contact: Mahmoud Tantawy, MD    +201221865587    drmtantawy@yahoo.com   
Contact: Mahmoud Tantawy, MD       drmtantawy@icloud.com   
Sponsors and Collaborators
Misr University for Science and Technology
Investigators
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Study Chair: Mahmoud Tantawy, MD Misr University for Science and Technology
More Information
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Additional Information:

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Responsible Party: Mahmoud Ahmed Tantawy, Consultant Cardiologist, Sr. Researcher, Health Strategist, Health Economist & Administrator, Misr University for Science and Technology
ClinicalTrials.gov Identifier: NCT04323345    
Other Study ID Numbers: MUST23032020
First Posted: March 26, 2020    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mahmoud Ahmed Tantawy, Misr University for Science and Technology:
Coronavirus
Natural Honey
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Pneumonia, Viral
Pneumonia
Respiratory Tract Infections
Infections
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases