Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04323345
Recruitment Status : 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

Tracking Information
First Submitted Date  ICMJE March 23, 2020
First Posted Date  ICMJE March 26, 2020
Last Update Posted Date April 21, 2020
Estimated Study Start Date  ICMJE April 15, 2020
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Rate of recovery from positive to negative swaps [ Time Frame: 14 days ]
    Percentage of patients turned from positive to negative swaps at day 14
  • Fever to normal temperature in days [ Time Frame: 14 days ]
    Number of days till no fever
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • 30 days mortality rate [ Time Frame: 30 days ]
    mortality rate in each group at 30 days
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus
Official Title  ICMJE The Efficacy of Natural Honey in Patients Infected With Novel Coronavirus (COVID-19) : A Randomized, Controlled ,Single Masked , Investigator Initiated, Multi-center Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Natural Honey Group

    Natural Honey

    1gm/kg/day divided into 2 to 3 doses for 14 days in addition to standard care

    Interventions:
    • Dietary Supplement: Natural Honey
    • Other: Standard Care
  • 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.
    Intervention: Other: Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 24, 2020)
1000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 15, 2021
Estimated Primary Completion Date December 15, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04323345
Other Study ID Numbers  ICMJE MUST23032020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mahmoud Ahmed Tantawy, Misr University for Science and Technology
Study Sponsor  ICMJE Misr University for Science and Technology
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mahmoud Tantawy, MD Misr University for Science and Technology
PRS Account Misr University for Science and Technology
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP