COVIDPhase 2/3NCT04351347
The Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment
A Phase 2/3 study testing Ivermectin in people with COVID, run by Tanta University at 1 site in Egypt.
Trial summary
Efficacy of Ivermectin in larger doses in COVID-19 treatment Read more about this study
- Who is it for?
- Any age
- 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
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jun 2020to 1 Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with covid 19
Who cannot join
- Allergy or side effects to treatment
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, 35111
Sherief Abd-Elsalam
About this study
Official title: Clinical Study Evaluating the Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment
Efficacy of Ivermectin in larger doses in COVID-19 treatment
Read the detailed description
Clinical Study Evaluating the Efficacy of Ivermectin in higher doses in COVID-19 treatment
- 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
ivermectin
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin alone in larger doses Receives: Drug: Ivermectin |
| Standard treatment | No intervention | Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with improvement or died
The number of patients with improvement or death
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start16 Jun 2020
- Primary completion1 Dec 2030 (estimated)
- Study completion1 Dec 2030 (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 Tanta 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherief Abd-Elsalam, Tanta University
- Investigators
- sherief Abd-Elsalam, Ass. Prof., Principal investigator, Tanta University - Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351347
- Sponsor's protocol ID
- ivermecin covid
- Status last verified
- Mar 2021
- First submitted
- 15 Apr 2020
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Efficacy of Ivermectin in Larger Doses in COVID-19 Treatment
- ClinicalTrials.gov ID
- NCT04351347
- Acronym / sponsor ID
- ivermecin covid
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 16 Jun 2020 (actual)
- Primary completion
- 1 Dec 2030 (estimated)
- Study completion
- 1 Dec 2030 (estimated)
- First posted
- 17 Apr 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.
Efficacy of Ivermectin in larger doses in COVID-19 treatment
Detailed description
Clinical Study Evaluating the Efficacy of Ivermectin in higher doses in COVID-19 treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ivermectin | Experimental | Drug: IvermectinIvermectin alone in larger doses |
| Standard treatment | No intervention | –Standard of care treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with covid 19
Key exclusion criteria (1 listed)
- Allergy or side effects to treatment
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 |
|---|---|---|
| Ivermectinivermectin | Drug | Ivermectin |
Primary outcome
Number of patients with improvement or died
Time frame: 1 month
The number of patients with improvement or death
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- 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.
sherief Abd-Elsalam, Ass. Prof. principal investigator
Tanta University - Faculty of Medicine
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 Tanta 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: looking for participants now, as of the sponsor's last update on 10 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherief Abd-Elsalam, ass. prof. (00201147773440, sheriefabdelsalam@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with improvement or died (time frame: 1 month). 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 10 Mar 2021.