Covid19NCT04747678
Adverse Effects of Ivermectin Used in Egypt During COVID-19
An observational study of Covid19 and Ivermectin Poisoning, run by Menoufia University at 1 site in Egypt.
Trial summary
retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Covid19, Ivermectin Poisoning, Drug Toxicity
- What is being tested?
- Ivermectin
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Feb 2021to 1 Mar 2021
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 16 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: all healthy and diseased people who used ivermectin the last three months either as a treatment or as a prophylaxis with mention of the doses used and the adverse effects experienced during and after the usage
Who may be able to join
- all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerability and Adverse Effects of Using Multiple Doses of Ivermectin in Egypt During Covid 19 Pandemic
retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt
Read the detailed description
ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens
- Conditions
- Covid19, Ivermectin Poisoning, Drug Toxicity, Drug Side Effect
- Being tested
- Ivermectin
- Medical subject headings
- COVID-19, Drug-Related Side Effects and Adverse Reactions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt
What is being measured
The primary outcome is the main question the study is designed to answer.
all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020
all data will be collected from retrospective manner as a retrospective study
Measured: the data will be collected from February 2021 to march 2021
Secondary outcomes (1)
all data will be arranged according to time and dose manner
data for each dose will be identified together
Measured: February to match 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start3 Feb 2021 (estimated)
- Primary completion28 Feb 2021 (estimated)
- Study completion1 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Menoufia 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mohamed esmat fahim mansour, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04747678
- Sponsor's protocol ID
- ahmed19782020
- Status last verified
- Feb 2021
- First submitted
- 1 Feb 2021
- Last updated
- 10 Feb 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability and Adverse Effects of Using Multiple Doses of Ivermectin in Egypt During Covid 19 Pandemic
- ClinicalTrials.gov ID
- NCT04747678
- Acronym / sponsor ID
- ahmed19782020
- Conditions
- Covid19, Ivermectin Poisoning, Drug Toxicity, Drug Side Effect
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 3 Feb 2021 (estimated)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 1 Mar 2021 (estimated)
- First posted
- 10 Feb 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.
retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt
Detailed description
ivermectin was used in Egypt during the pandemic of covid-19 and it was registered in the MOH protocol that has been published in November 2020 the study will document the adverse effects of many patients used ivermectin as aprophylaxis and as a treatment with multiple dose regimens
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- all healthy and diseased people who used ivermectin the last three months either as a treatment or as a prophylaxis with mention of the doses used and the adverse effects experienced during and after the usage
Key inclusion criteria (1 listed)
- all people used ivermectin as a treatment or as a prophylactic in covid 19 pandemic in egypt with explained dose
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Ivermectinretrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt | Drug | – |
Primary outcome
all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020
Time frame: the data will be collected from February 2021 to march 2021
all data will be collected from retrospective manner as a retrospective study
1 secondary outcome
all data will be arranged according to time and dose manner
Time frame: February to match 2021
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2021.
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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?
An observational study of Covid19 and Ivermectin Poisoning, run by Menoufia 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 10 Feb 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?
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?
all adverse effects will be collected from people used Ivermectin in between September 2020 to December 2020 (time frame: the data will be collected from February 2021 to march 2021). 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 Feb 2021.