COVID-19Phase 3NCT04323345
Efficacy of Natural Honey Treatment in Patients With Novel Coronavirus
A Phase 3 study testing Natural Honey in people with COVID-19, run by Misr University for Science and Technology at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 75 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Natural Honey
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Apr 2020to 15 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Meeting the criteria for diagnosis of COVID-19, either clinically or as confirmed by positive swap.
Who cannot join
- Children below 5 years old. Severely ill patients with either terminal disease. Nil per os (NPO) patients with contraindication to nasogastric tube feeding.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mahmoud Tantawy
Cairo
Mahmoud Tantawy, MD, +201221865587, drmtantawy@yahoo.com
Mahmoud Tantawy, MD, drmtantawy@icloud.com
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- Natural Honey, Standard Care
- Keywords
- Coronavirus, Natural Honey
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natural HoneyDietary supplement
Natural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube.
Standard CareOther
Supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.
| Study group | Role | What they receive |
|---|---|---|
| Natural Honey Group | Experimental | Natural Honey
1gm/kg/day divided into 2 to 3 doses for 14 days in addition to standard care Receives: 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. Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recovery from positive to negative swaps
Percentage of patients turned from positive to negative swaps at day 14
Measured: 14 days
Fever to normal temperature in days
Number of days till no fever
Measured: 14 days
Resolution of lung inflammation in CT or X ray
Number of days till lungs recovery in chest X ray or CT
Measured: 30 days
Secondary outcomes (2)
30 days mortality rate
mortality rate in each group at 30 days
Measured: 30 days
Number of days till reaching negative swab results
Number of days from initiation of intervention till changing of the swap test result from positive to negative
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start15 Apr 2020 (estimated)
- Primary completion15 Dec 2020 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Ahmed Tantawy, Misr University for Science and Technology
- Investigators
- Mahmoud Tantawy, MD, Study chair, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323345
- Sponsor's protocol ID
- MUST23032020
- Status last verified
- Apr 2020
- First submitted
- 23 Mar 2020
- Last updated
- 21 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04323345
- Acronym / sponsor ID
- MUST23032020
- Conditions
- COVID-19
- Keywords
- Coronavirus, Natural Honey
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 15 Apr 2020 (estimated)
- Primary completion
- 15 Dec 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Natural Honey Group | Experimental | Dietary Supplement: Natural Honey, Other: Standard CareNatural Honey 1gm/kg/day divided into 2 to 3 doses for 14 days in addition to standard care |
| Standard Care | Active comparator | Other: Standard CareCurrent standard care including supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin. |
Who may qualify
- Ages
- 5 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Meeting the criteria for diagnosis of COVID-19, either clinically or as confirmed by positive swap.
Key exclusion criteria (1 listed)
- Children below 5 years old. Severely ill patients with either terminal disease. Nil per os (NPO) patients with contraindication to nasogastric tube feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Natural HoneyNatural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube. | Dietary supplement | Natural Honey Group |
| Standard CareSupportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin. | Other | Natural Honey Group, Standard Care |
Primary outcome
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
2 secondary outcomes
30 days mortality rate
Time frame: 30 days
Number of days till reaching negative swab results
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2020.
- Honey for acute cough in childrenLink provided by the sponsor.
- NICE Guidelines (NG120)Link provided by the sponsor.
- The scolicidal effects of honeyLink provided by the sponsor.
- Antimicrobial properties of honeyLink provided by the sponsor.
- In vitro antiviral activity of honey against varicella zoster virus (VZV): A translational medicine study for potential remedy for shinglesLink provided by the sponsor.
- Antiviral Activities of Honey, Royal Jelly, and Acyclovir Against HSV-1Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mahmoud Tantawy, MD study chair
Misr University for Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Natural Honey in people with COVID-19, run by Misr University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recovery from positive to negative swaps (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2020.