COVIDPhase 2/3NCT04445311
Ivermectin in Treatment of COVID-19
A Phase 2/3 study testing Ivermectin in people with COVID, run by Zagazig University at 1 site in Egypt.
Trial summary
confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- COVID
- What is being tested?
- Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 31 May 2020to 15 Aug 2020
- Phase
- Phase 2/3
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 patients during period of the study more than 18 years old
Who cannot join
- refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with ivermectin
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Waheed Shouman
Zagazig, Sharqia Province, 44519
Waheed Shouman, MD, +201114812048, shouman66@gmail.com
About this study
Official title: Use of Ivermectin as a Therapeutic Option for Patients With COVID-19
confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt
- Conditions
- COVID
- Being tested
- Ivermectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
3 successive days ttt of ivermectin started within 48 hours of symptoms
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin group | Experimental | group that will receive ivermectin plus standard of care ttt Receives: Drug: Ivermectin |
| Control group | No intervention | group that will receive standard of care ttt |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to be symptoms free
duration from day 1 symptoms till 3 days without symptoms
Measured: within 21 days after enrollment
Secondary outcomes (4)
hospitalization
need hospital admission
Measured: within 21 days after enrollement
Mechanical ventilation
need mechanical ventilation
Measured: within 21 days after enrollement
length of stay
days spent in hospital
Measured: within one month days after enrollement
mortality
survived or died
Measured: within one month 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 posted24 Jun 2020
- Study start31 May 2020
- Primary completion30 Jul 2020 (estimated)
- Study completion15 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies of the same condition, open and under way.
- More trials run by Zagazig UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
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
- NCT04445311
- Sponsor's protocol ID
- ZU-IRB#6151/31-5-2020
- Status last verified
- Jun 2020
- First submitted
- 19 Jun 2020
- Last updated
- 24 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ivermectin as a Therapeutic Option for Patients With COVID-19
- ClinicalTrials.gov ID
- NCT04445311
- Acronym / sponsor ID
- ZU-IRB#6151/31-5-2020
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 31 May 2020 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 15 Aug 2020 (estimated)
- First posted
- 24 Jun 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.
confirmed cases with COVID-19 will receive ivermectin as a therapeutic option as well as standard of care treatment and will be compared to those that will receive only standard of care ttt
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin group | Experimental | Drug: Ivermectingroup that will receive ivermectin plus standard of care ttt |
| Control group | No intervention | –group that will receive standard of care ttt |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COVID-19 patients during period of the study more than 18 years old
Key exclusion criteria (1 listed)
- refuse to participate pregnancy or lactation hypersensitivity to ivermectin receive any drug with interaction with 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 |
|---|---|---|
| Ivermectin3 successive days ttt of ivermectin started within 48 hours of symptoms | Drug | Ivermectin group |
Primary outcome
time to be symptoms free
Time frame: within 21 days after enrollment
duration from day 1 symptoms till 3 days without symptoms
4 secondary outcomes
hospitalization
Time frame: within 21 days after enrollement
Mechanical ventilation
Time frame: within 21 days after enrollement
length of stay
Time frame: within one month days after enrollement
mortality
Time frame: within one month 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 24 Jun 2020.
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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 Phase 2/3 study testing Ivermectin 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: status not confirmed, as of the sponsor's last update on 24 Jun 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Waheed Shouman, MD (+201114812048, shouman66@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to be symptoms free (time frame: within 21 days after enrollment). 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 24 Jun 2020.