Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus

NCT04323345 | Unknown Phase 3 DMC

• 1 other identifier: MUST23032020
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Coronavirus; Natural Honey

Outcome Measures

Primary Outcomes (3)

• Rate of recovery from positive to negative swaps

  Percentage of patients turned from positive to negative swaps at day 14

  14 days

• Fever to normal temperature in days

  Number of days till no fever

  14 days

• Resolution of lung inflammation in CT or X ray

  Number of days till lungs recovery in chest X ray or CT

  30 days

Secondary Outcomes (2)

• 30 days mortality rate

  30 days

• Number of days till reaching negative swab results

  30 days

Study Arms (2)

Natural Honey Group

EXPERIMENTAL

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

Dietary Supplement: Natural Honey; Other: Standard Care

Standard Care

ACTIVE COMPARATOR

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

Interventions

Natural Honey DIETARY_SUPPLEMENT

Natural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube.

Natural Honey Group

Standard Care OTHER

Supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.

Natural Honey Group; Standard Care

Eligibility Criteria

• Age: 5 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Meeting the criteria for diagnosis of COVID-19, either clinically or as confirmed by positive swap.

You may not qualify if:

• Children below 5 years old. Severely ill patients with either terminal disease. Nil per os (NPO) patients with contraindication to nasogastric tube feeding.

Sponsors & Collaborators

• Misr University for Science and Technology: lead

Study Sites (1)

Mahmoud Tantawy

Cairo, Egypt

RECRUITING

Related Links

• Honey for acute cough in children
• NICE Guidelines (NG120)
• The scolicidal effects of honey
• Antimicrobial properties of honey
• In vitro antiviral activity of honey against varicella zoster virus (VZV): A translational medicine study for potential remedy for shingles
• Antiviral Activities of Honey, Royal Jelly, and Acyclovir Against HSV-1
• Therapeutic Manuka Honey: No Longer So Alternative
• Honey-based dressings and wound care: an option for care in the United States

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mahmoud Tantawy, MD

  Misr University for Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist, Sr. Researcher, Health Strategist, Health Economist & Administrator

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: March 26, 2020
• Study Start: April 15, 2020
• Primary Completion: December 15, 2020
• Study Completion: January 15, 2021
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)