None listed
Conditions
Brief summary
We have shown that medical grade manuka honey inhibits SARS-CoV-2, the virus responsible for Covid-19. Medical grade manuka honey has a high concentration of methylglyoxal (>550 mg/kg) that has known antibacterial properties and may also now have antiviral properties. SARS-CoV-2 enters the respiratory track and concentrates in the lungs. Therefore, manuka honey might provide a simple and cost-effective means to control the viral burden at the source of entry into the body. We believe that medical grade manuka honey may be used to treat subjects with Covid-19 through administration into the lungs as an atomised mist generated via a nebulizer. Before offering manuka honey as a treatment to patients with Covid-19, we need to establish that administration via nebulization is safe, tolerable and has no side-effects. To date, we only have anecdotal evidence from dozens of people whom have taken manuka honey in nebulizers at 50% v/v in sterile saline to help combat the common cold. Those individuals claimed that it helped them to recover faster and that there were no side-effects or difficulties in taking manuka honey in this way. The present study seeks to determine the safety and optimal dose of medical grade manuka honey for use in a nebulizer solution. We will examine the effect of doses up to 50% v/v on saturated oxygen, heart rate, breathing rate, temperature, lung performance measurements and evaluate subject feedback by way of a questionnaire.
Interventions
Up to 15 subjects will be recruited and each will be required to sequentially take sterile saline (control), 3.13, 6.25, 12.5, 25 and 50% v/v medical grade manuka honey in a nebuliser solution for 10 min.
Subjects will be tested at either the Ruakura Research Centre (Hamilton), or at the ManukaMed facility (Masterton). Participants will self-administer the doses under the supervision of the principle investigator. One of each of the doses will be administered on successive days for a total of
Up to 15 subjects will be recruited and each will be required to sequentially take sterile saline (control), 3.13, 6.25, 12.5, 25 and 50% v/v medical grade manuka honey in a nebuliser solution for 10 min. Subjects will be tested at either the Ruakura Research Centre (Hamilton), or at the ManukaMed facility (Masterton). Participants will self-administer the doses under the supervision of the principle investigator. One of each of the doses will be administered on successive days for a total of 6 days. The nebulizer is a jet (compressor) type that delivers 0.3 mL per min with a mean particle diameter of 3 uM (model C801, Omron Healthcare Ltd, Kyoto, Japan). Therefore, subjects will breath 3 mL over the 10 min period. The volume administered during the 10 min period will be the product of the volume added minus the volume remaining after 10 min. The nebulizer has not been approved for this use, nor has approval been sought by either the manufacturer, or the New Zealand Medicines and Medical Devices Safety Authority. During the 10 min treatment period, subjects will wear a silicone face mask provided with the nebulizer.
Sponsors
ManukaMed LP
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Be able and willing to give written informed consent, 2. Understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the Investigator, 3. Male and female subjects who are 18 to 80 years of age, 4. Subjects are not currently ill, or have a history of respiratory or cardiac disease, 5. Have vital signs that are within the normal range at time of screening (blood pressure 90/60 to 120/80 mm Hg; pulse 60-100 beats per min; breathing 12-20 breaths per min; temperature 36.5 to 37.3 °C), 6. Have lung performance parameters that are within the predicted range for their age and sex at time of screening (European Respiratory Society (ERS), European Community for Coal and Steel (ECCS)/Knudson) provided by the spirometer software (WinspiroPRO).
Exclusion criteria
1. Subjects who are hypersensitive, or have an allergic reaction to honey, or bee products. 2. Subjects who are on medication that may influence pulmonary measurements. 3. Subjects who are asthmatics. 4. Subjects who are ill (including common cold) on the day, or for the previous week(s). 5. Subject has a history or presence of significant cardiovascular disease, including having a cardiac pacemaker, 6. Subject has a significant acute or chronic coexisting illness which in the opinion of the investigator, could affect the outcome of the study, including kidney, liver or renal disease/dysfunction, uncontrolled metabolic disease, 7. Subject has a history of hypertension or elevated blood pressure (systolic, >140 mmHg or a diastolic, >90 mmHg), unless on stable anti-hypertensive medication for at least 3 months prior to and for the duration of the study, 8. Subject has a history of drug and / or alcohol abuse, 9. Individuals who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial.
Outcome results
None listed