COVIDPhase 2/3NCT04403555
Ivermectin as a Novel Therapy 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 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR.
Who cannot join
- Allergy or contraindication to the drugs used in the study.
- Pregnant and lactating mothers.
- Patients with cardiac problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Ivermectin in COVID-19 Treatment
Efficacy of Ivermectin in COVID-19 treatment
Read the detailed description
Clinical Study Evaluating the Efficacy of Ivermectin 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
Also called iverzine, ivermectin
Ivermectin treatment
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | Ivermectin plus standard of care treatment Dose 2 tablets 12mg per day for 3 days Receives: Drug: Ivermectin |
| Standard of care | No intervention | Standard of care treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with mortality
Improvement of survival
Measured: 1 month
Secondary outcomes (2)
Length of hospital stay
Effect on the length of hospital stay
Measured: 1 month
The need for mechanical ventilation
Need for mechanical ventilation
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 posted27 May 2020
- Study start1 Jun 2020
- Primary completion31 Oct 2020
- Study completion1 Dec 2020
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
- 164 participants (actual)
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, ass. Prof. Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04403555
- Sponsor's protocol ID
- tanta covid treatment
- Status last verified
- Jul 2021
- First submitted
- 23 May 2020
- Last updated
- 2 Aug 2021
- 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 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Ivermectin in COVID-19 Treatment
- ClinicalTrials.gov ID
- NCT04403555
- Acronym / sponsor ID
- tanta covid treatment
- Conditions
- COVID
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 27 May 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 COVID-19 treatment
Detailed description
Clinical Study Evaluating the Efficacy of Ivermectin 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 plus standard of care treatment Dose 2 tablets 12mg per day for 3 days |
| Standard of care | 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)
- All Adult Patients aging from 20 to 65 years-old with COVID-19 confirmed by pharyngeal swab PCR.
Key exclusion criteria (3 listed)
- Allergy or contraindication to the drugs used in the study.
- Pregnant and lactating mothers.
- Patients with cardiac problems.
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 |
|---|---|---|
| IvermectinAlso: iverzine, ivermectinIvermectin treatment | Drug | Ivermectin |
Primary outcome
The number of patients with mortality
Time frame: 1 month
Improvement of survival
2 secondary outcomes
Length of hospital stay
Time frame: 1 month
The need for mechanical ventilation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 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. This study is not recruiting at the moment.
sherief Abd-Elsalam, Ass. Prof. principal investigator
ass. Prof. Tropical 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 3 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 2 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The number of patients with mortality (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 2 Aug 2021.