COVIDPhase 2/3NCT04422561
Prophylactic Ivermectin in COVID-19 Contacts
A Phase 2/3 study testing Ivermectin Tablets in people with COVID, run by Zagazig University at 1 site in Egypt.
Trial summary
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of COVID -19 Read more about this study
- Who is it for?
- Ages 16 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID
- What is being tested?
- Ivermectin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteEgypt
- Study dates
- 31 May 2020to 27 Jul 2020
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- family contact of confirmed COVID-19 case
Who cannot join
- refuse to participate and receive the drug pregnancy or lactation known hypersensitivity to ivermectin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of COVID -19
- Conditions
- COVID
- Being tested
- Ivermectin Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin TabletsDrug
two doses 72 hours apart
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin group | Experimental | Contacts who will receive prophylactic ivermectin Receives: Drug: Ivermectin Tablets |
| Control group | No intervention | Contacts who will be only observed without prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
history taking and clinical examination
Measured: within 14 days after enrollement
Secondary outcomes (1)
Development of COVID
by swab
Measured: within 14 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 posted9 Jun 2020
- Study start31 May 2020
- Primary completion14 Jul 2020
- Study completion27 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVIDStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Waheed Shouman, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422561
- Sponsor's protocol ID
- ZU-IRB#6150/31-5-2020
- Status last verified
- Aug 2020
- First submitted
- 6 Jun 2020
- Last updated
- 27 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ivermectin as a Prophylactic Option in Asymptomatic Family Close Contact for Patient With COVID-19
- ClinicalTrials.gov ID
- NCT04422561
- Acronym / sponsor ID
- ZU-IRB#6150/31-5-2020
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 340 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 31 May 2020 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 27 Jul 2020 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Posted 27 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
asymptomatic family close contact of confirmed COVID -19 patient will receive prophylactic ivermectin and will be followed up for 14 days for any symptoms \& diagnosis of COVID -19
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin group | Experimental | Drug: Ivermectin TabletsContacts who will receive prophylactic ivermectin |
| Control group | No intervention | –Contacts who will be only observed without prophylaxis |
Who may qualify
- Ages
- 16 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- family contact of confirmed COVID-19 case
Key exclusion criteria (1 listed)
- refuse to participate and receive the drug 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 Tabletstwo doses 72 hours apart | Drug | Ivermectin group |
Primary outcome
Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath)
Time frame: within 14 days after enrollement
history taking and clinical examination
1 secondary outcome
Development of COVID
Time frame: within 14 days after enrollement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ivermectin Tablets in people with COVID, run by Zagazig 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 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: finished, as of the sponsor's last update on 27 Aug 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 27 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Symptoms ( Fever ,Cough, Sore Throat, Myalgia,Diarrhea, Shortness of Breath) (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 27 Aug 2020; AzTrials last refreshed its copy on 1 Nov 2026.