Covid19Phase 4IRICTNCT04746365
Ivermectin Role in Covid-19 Clinical Trial
A Phase 4 study testing ivermectin and hydroxychloroquine in people with Covid19, run by Elaraby Hospital at 1 site in Egypt.
Trial summary
Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. 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 and hydroxychloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Dec 2020to 6 Feb 2021
- Phase
- Phase 4
- 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
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of OP swabs and venous blood per protocol.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
- Severe cases according to WHO definition.
Who cannot join
- ALT/AST > 5 times the upper limit of normal.
- Mortality within 12 hours of admission.
- Pregnancy.
- Anticipated transfer to another hospital within 24 hours.
- Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
- Mechanically ventilated on admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ivermectin Role in Severe Covid-19 Treatment; a Double-blinded, Randomized Clinical Trial
Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6, 2020, to January 31, 2021.
Read the detailed description
This study is an adaptive, randomized, double-blinded, controlled trial to evaluate the safety and efficacy of therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a single-center trial that will be conducted in Shebin Elkom teaching hospital. The study will be a series of 3-arm comparisons between two different investigational therapeutic agents (Ivermectin and Hydroxychloroquine) and a placebo. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about the successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.
- Conditions
- Covid19
- Being tested
- ivermectin, hydroxychloroquine, Placebo
- 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
ivermectin is anthelmintic
hydroxychloroquine is antimalarial.
PlaceboDrug
Standard treatments
| Study group | Role | What they receive |
|---|---|---|
| ivermectin | Experimental | ivermectin was given as a total daily dose of 36 mg on days 0, 3, 6. The daily dose was divided into 3 equal doses of 12 mg (2 tablets) every 8 hours Receives: Drug: ivermectin |
| hydroxychloroquine | Experimental | hydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days Receives: Drug: hydroxychloroquine |
| Placebo | Placebo comparator | Unlabelled standard treatment according to the clinical condition of patients Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the WHO ordinal scale of clinical status by at least two points
The ordinal scale consists of 7 points, the maximum score is 7 which indicates a worst outcome, while the minimum score is 1 which indicates a better outcome
Measured: 14 days
Time to discharge
time to discharge to home after no more need for hospitalization
Measured: within 14 days
Secondary outcomes (1)
Mortality
All-causes mortality
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start6 Dec 2020
- Primary completion31 Jan 2021
- Study completion6 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elaraby Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shebin El-Kom Teaching Hospital
- Responsible party
- Principal investigator, Hozaifa Elsawah, Elaraby Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04746365
- Sponsor's protocol ID
- 1029076
- Other IDs
- 2101001
- Acronym
- IRICT
- Status last verified
- Feb 2021
- First submitted
- 6 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Elshafie AH, Elsawah HK, Hammad M, Sweed EM, Seif AS, Abdel Ghaffar MM, Goda FM, Mosalam EM, Abdallah MS. Ivermectin role in COVID-19 treatment (IRICT): single-center, adaptive, randomized, double-blind, placebo-controlled, clinical trial. Expert Rev Anti Infect Ther. 2022 Oct;20(10):1341-1350. doi: 10.1080/14787210.2022.2098113. Epub 2022 Jul 12.
PubMed 35788169
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin Role in Severe Covid-19 Treatment; a Double-blinded, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04746365
- Acronym / sponsor ID
- IRICT / 1029076
- Conditions
- Covid19
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Elaraby HospitalUniversity, hospital or other
- Collaborators
- Shebin El-Kom Teaching Hospital
- Study start
- 6 Dec 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 6 Feb 2021 (actual)
- First posted
- 9 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.
Because ivermectin is being used to treat COVID-19 with insufficient evidence, the investigator conducted a randomized clinical trial to investigate the efficacy and safety of ivermectin in comparison to hydroxychloroquine and placebo in severe COVID-19 patients. The study was conducted in Shebin-Elkom teaching hospital and recruited patients from December 6, 2020, to January 31, 2021.
Detailed description
This study is an adaptive, randomized, double-blinded, controlled trial to evaluate the safety and efficacy of therapeutic agents in hospitalized adult patients diagnosed with COVID-19. The study is a single-center trial that will be conducted in Shebin Elkom teaching hospital. The study will be a series of 3-arm comparisons between two different investigational therapeutic agents (Ivermectin and Hydroxychloroquine) and a placebo. There will be interim monitoring to allow early stopping for futility, efficacy, or safety. Because of the possibility that background standards of supportive care may evolve/improve over time as more is learned about the successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized participants. An independent data and safety monitoring board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Randomized, double-blinded, controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| ivermectin | Experimental | Drug: ivermectinivermectin was given as a total daily dose of 36 mg on days 0, 3, 6. The daily dose was divided into 3 equal doses of 12 mg (2 tablets) every 8 hours |
| hydroxychloroquine | Experimental | Drug: hydroxychloroquinehydroxychloroquine was given as 200 mg (one tablet) every 12 hours for 5 days |
| Placebo | Placebo comparator | Drug: PlaceboUnlabelled standard treatment according to the clinical condition of patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
- Understands and agrees to comply with planned study procedures.
- Agrees to the collection of OP swabs and venous blood per protocol.
- Male or non-pregnant female adult ≥18 years of age at time of enrollment.
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other
Key exclusion criteria (6 listed)
- ALT/AST > 5 times the upper limit of normal.
- Mortality within 12 hours of admission.
- Pregnancy.
- Anticipated transfer to another hospital within 24 hours.
- Allergy to any study medication commercial or public health assay in any specimen prior to randomization.
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 is anthelmintic | Drug | ivermectin |
| hydroxychloroquinehydroxychloroquine is antimalarial. | Drug | hydroxychloroquine |
| PlaceboStandard treatments | Drug | Placebo |
Primary outcome
Reduction in the WHO ordinal scale of clinical status by at least two points
Time frame: 14 days
The ordinal scale consists of 7 points, the maximum score is 7 which indicates a worst outcome, while the minimum score is 1 which indicates a better outcome
Time to discharge
Time frame: within 14 days
time to discharge to home after no more need for hospitalization
1 secondary outcome
Mortality
Time frame: 14 days
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 9 Feb 2021.
- Derived from this study: PubMed 35788169Elshafie AH, Elsawah HK, Hammad M, Sweed EM, Seif AS, Abdel Ghaffar MM, Goda FM, Mosalam EM, Abdallah MS. Ivermectin role in COVID-19 treatment (IRICT): single-center, adaptive, randomized, double-blind, placebo-controlled, clinical trial. Expert Rev Anti Infect Ther. 2022 Oct;20(10):1341-1350. doi: 10.1080/14787210.2022.2098113. Epub 2022 Jul 12.
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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?
A Phase 4 study testing ivermectin and hydroxychloroquine in people with Covid19, run by Elaraby Hospital 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 6 inclusion and 6 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 9 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Reduction in the WHO ordinal scale of clinical status by at least two points (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04746365, which also lists 1 linked publication.
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 9 Feb 2021.