Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus

• ClinicalTrials.gov Identifier: NCT04323345
• Recruitment Status: Recruiting
• First Posted: March 26, 2020
• Last Update Posted: April 21, 2020
• Sponsor: Misr University for Science and Technology
• Information provided by (Responsible Party): Mahmoud Ahmed Tantawy, Misr University for Science and Technology

Tracking Information

• First Submitted Date: March 23, 2020
• First Posted Date: March 26, 2020
• Last Update Posted Date: April 21, 2020
• Estimated Study Start Date: April 15, 2020
• Estimated Primary Completion Date: December 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: 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.

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 24, 2020): 1000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 15, 2021
• Estimated Primary Completion Date: December 15, 2020 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 5 Years to 75 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT04323345
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Responsible Party: Mahmoud Ahmed Tantawy, Misr University for Science and Technology
• Study Sponsor: Misr University for Science and Technology
• Collaborators: Not Provided

Investigators

• Study Chair: Mahmoud Tantawy, MD; Misr University for Science and Technology

• PRS Account: Misr University for Science and Technology
• Verification Date: April 2020