Covid-19NCT04723459
Efficacy of Nano-Ivermectin Impregnated Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
A study testing ivermectin impregnated mask in people with Covid-19, run by South Valley University at 1 site in Egypt.
Trial summary
Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid-19
- What is being tested?
- ivermectin impregnated mask
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- 23 Jan 2021to 28 Mar 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- health care personells and family contact of confirmed COVID-19 cases.
Who cannot join
- refusal of participate to use the masks.
- pregnancy or lactation known hypersensitivity to ivermectin.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Zaky Aref
Qina, 83511
Zaky Aref, 01001771210 ext. 002, doctor.aref@hotmail.com
About this study
Official title: Nano-Ivermectin Impregnated Masks Versus Ordinary Surgical Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks
Read the detailed description
Antiviral effecacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks this study is a trial for evaluation of adding a proved antiviral material to the mask and to compare between the protective value of this mask and the ordinary one.
- Conditions
- Covid-19
- Being tested
- ivermectin impregnated mask
- Keywords
- Covid-19, antiviral mask, nano ivermectin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivermectin impregnated maskOther
mask with ivermectin nano solution
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin mask group | Active comparator | Contacts who will use ivermectin masks Receives: Other: ivermectin impregnated mask |
| ordinary mask group | No intervention | Contacts who will use regular masks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of persons in each group who Complain of any suspected Symptoms
( Fever, Myalgia ,Cough, Sore Throat, Diarrhea, Shortness of Breath)
Measured: within 14 days after enrollement
Secondary outcomes (1)
Number of persons in each group who are diagnosed as COVID-19 patients
swab test
Measured: within 21 days after enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start23 Jan 2021
- Primary completion19 Feb 2021
- Study completion28 Mar 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sequential Assignment
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaky Aref, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04723459
- Sponsor's protocol ID
- SVU MED CIT0 23 4 21 1 121
- Status last verified
- Mar 2021
- First submitted
- 20 Jan 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nano-Ivermectin Impregnated Masks Versus Ordinary Surgical Masks in Prevention of Covid-19 Among Healthy Contacts and Medical Staff
- ClinicalTrials.gov ID
- NCT04723459
- Acronym / sponsor ID
- SVU MED CIT0 23 4 21 1 121
- Conditions
- Covid-19
- Keywords
- Covid-19, antiviral mask, nano ivermectin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 23 Jan 2021 (actual)
- Primary completion
- 19 Feb 2021 (actual)
- Study completion
- 28 Mar 2021 (estimated)
- First posted
- 25 Jan 2021 (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.
Antiviral efficacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks
Detailed description
Antiviral effecacy of Ivermectin against Covid-19 in vitro was stated by many stusies all over the world with decreased effecacy in vivo so ,usage of masks impregnated into nano Ivermectin solution will theoretically increase the protective action of the ordinary masks this study is a trial for evaluation of adding a proved antiviral material to the mask and to compare between the protective value of this mask and the ordinary one.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Assignment
| Arm | Type | Receives |
|---|---|---|
| Ivermectin mask group | Active comparator | Other: ivermectin impregnated maskContacts who will use ivermectin masks |
| ordinary mask group | No intervention | –Contacts who will use regular masks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- health care personells and family contact of confirmed COVID-19 cases.
Key exclusion criteria (2 listed)
- refusal of participate to use the masks.
- pregnancy or lactation known hypersensitivity to ivermectin.
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 |
|---|---|---|
| ivermectin impregnated maskmask with ivermectin nano solution | Other | Ivermectin mask group |
Primary outcome
Number of persons in each group who Complain of any suspected Symptoms
Time frame: within 14 days after enrollement
( Fever, Myalgia ,Cough, Sore Throat, Diarrhea, Shortness of Breath)
1 secondary outcome
Number of persons in each group who are diagnosed as COVID-19 patients
Time frame: within 21 days after enrollement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ivermectin impregnated mask in people with Covid-19, run by South Valley University 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 2 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 17 Mar 2021. 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.
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?
Contact Zaky Aref (+201001771210, doctor.aref@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of persons in each group who Complain of any suspected Symptoms (time frame: within 14 days after enrollement). 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 17 Mar 2021.