Covid19NCT04425707
Ivermectin In Treatment of COVID 19 Patients
A study testing Ivermectin in people with Covid19, run by Ministry of Health and Population, Egypt at 1 site in Egypt.
Trial summary
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- 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
- 9 Jun 2020to 1 Sep 2020
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap
Who cannot join
- Contraindications for the drug: hypersensitivity.
- Any medications with possible drug interactions.
- Severe cases.
- Any malignant condition.
- Pregnant females.
- Breast feeding females.
- Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to potential severe drug interaction.
Trial locations and contacts
1 site in 1 country.
noha mo asem, MD contact
Egypt1 site, 1 recruiting
- Recruiting
isolation and referal hospitals for COVID 19 patients
Cairo
ehab ah kamal, MD, 01006162663
About this study
Official title: The Use of Ivermectin In the Treatment of COVID 19 Patients
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
Read the detailed description
the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients
- Conditions
- Covid19
- Being tested
- Ivermectin
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called hydroxychloroquine
use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
| Study group | Role | What they receive |
|---|---|---|
| A ivermectin alone | Experimental | ivermectin will be administarted alone to COVID 19 patients Receives: Drug: Ivermectin |
| B standard care alone | Experimental | standard care will be administarted alone Receives: Drug: Ivermectin |
| C ivermectin added to standard of care | Active comparator | ivermectin will be administarted in adition to standard care Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the role of Ivermectin as a line of treatment for COVID 19
the role of ivermectin in the cure of COVID 19 patients
Measured: 2 months
Secondary outcomes (1)
To asses the rate of viral clearance in comparison to other treatment protocols.
to compare the results of ivermectin with the standard care
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start9 Jun 2020
- Primary completion1 Jul 2020 (estimated)
- Study completion1 Sep 2020 (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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health and Population, Egypt
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr. Ehab kamal, Ministry of Health and Population, Egypt
- Investigators
- houssam ho masoud, MD, Study director, COVID sceintific comittee ministry of health and population
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04425707
- Sponsor's protocol ID
- 14-2020/3
- Status last verified
- Jun 2020
- First submitted
- 8 Jun 2020
- Last updated
- 11 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 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ivermectin In the Treatment of COVID 19 Patients
- ClinicalTrials.gov ID
- NCT04425707
- Acronym / sponsor ID
- 14-2020/3
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ministry of Health and Population, EgyptOther government
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 1 Jul 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 11 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.
as Egypt suffered a lot during the pandemic of COVID 19 with limited drug choices, many of the patients could not acheive viral clearence with the standard module of care teh idea of introduction of new medications in the treatment protocol of COVID 19 managment. Ivermectin had shown a promising results in vitro studies and in limited in vivo studies. this clinical trial may open a new hope for COVID 19 patients as a new and cheap line of treatment
Detailed description
the study will compare the effect of ivermectin in comaprison and addition to the standard mode of care for the COVID 19 patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A ivermectin alone | Experimental | Drug: Ivermectinivermectin will be administarted alone to COVID 19 patients |
| B standard care alone | Experimental | Drug: Ivermectinstandard care will be administarted alone |
| C ivermectin added to standard of care | Active comparator | Drug: Ivermectinivermectin will be administarted in adition to standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral RNA swap
Key exclusion criteria (7 listed)
- Contraindications for the drug: hypersensitivity.
- Any medications with possible drug interactions.
- Severe cases.
- Any malignant condition.
- Pregnant females.
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: hydroxychloroquineuse of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt | Drug | A ivermectin alone, B standard care alone, C ivermectin added to standard of care |
Primary outcome
to evaluate the role of Ivermectin as a line of treatment for COVID 19
Time frame: 2 months
the role of ivermectin in the cure of COVID 19 patients
1 secondary outcome
To asses the rate of viral clearance in comparison to other treatment protocols.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 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.
noha mo asem, MD contact
houssam ho masoud, MD study director
COVID sceintific comittee ministry of health and population
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ivermectin in people with Covid19, run by Ministry of Health and Population, Egypt 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 7 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 11 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.
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 ehab ah kamal, MD (01006162663, ehabkamal2011@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the role of Ivermectin as a line of treatment for COVID 19 (time frame: 2 months). 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 11 Jun 2020.