COVID-19NCT04429711
Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19
A study testing Ivermectin Oral Product in people with COVID-19, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Ivermectin Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 12 May 2020to 31 Oct 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants eligible for inclusion will include non-pregnant adult (>18 years old) with molecular confirmation of COVID-19. [Participants will be eligible in a period of no longer than 72 hours after exposure].
Who cannot join
- Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
- Weight below 40Kg or above 100Kg
- Unable to take oral medication
- Known allergy to the drugs
- Pregnancy or breast feeding
- Participating in another RCT for treatment of COVID-19.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center
Ramat Gan
Eli Schwartz, M.D, +972-35308456, Eli.schwartz@sheba.health.gov.il
About this study
Official title: Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial
Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.
In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.
- Conditions
- COVID-19
- Being tested
- Ivermectin Oral Product
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivermectin Oral ProductDrug
3mg Capsules, 12-15mg/ day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| IVERMECTIN | Placebo comparator | Not described Receives: Drug: Ivermectin Oral Product |
| PLACEBO | Active comparator | Not described Receives: Drug: Ivermectin Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral clearance at day 6
The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
Measured: Outcome will be determined till 6 days post intervention
Viral shedding duration
Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
Measured: Outcome will be determined till 14 days post intervention
Symptoms clearance time
Time between drug treatment and symptoms resolution
Measured: Outcome will be determined till 14 days post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start12 May 2020
- Primary completion30 Sep 2020 (estimated)
- Study completion31 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Prof. Eli Schwartz MD, DTMH, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04429711
- Sponsor's protocol ID
- SHEBA-20-7156-ES-CTIL
- Status last verified
- Jun 2020
- First submitted
- 24 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ivermectin vs. Placebo for the Treatment of Patients With Mild to Moderate COVID-19 to Prevent Progression to Severe Infection and to Decrease Viral Shedding - A Double Blind , Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04429711
- Acronym / sponsor ID
- SHEBA-20-7156-ES-CTIL
- Conditions
- COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 12 May 2020 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 31 Oct 2020 (estimated)
- First posted
- 12 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.
Ivermectin which is an FDA-approved broad spectrum anti-parasitic agent, has also anti-viral activity. In vitro study have shown its activity against SARS-CoV-2, however its clinical effect on patients with COVID-19 never been tested.
In this RCT we would like to evaluate the effect of Ivermectin on reduction of viral shedding among mild to moderate COVID-19 patients, and in shortening the symptom resolution time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized
| Arm | Type | Receives |
|---|---|---|
| IVERMECTIN | Placebo comparator | Drug: Ivermectin Oral Product |
| PLACEBO | Active comparator | Drug: Ivermectin Oral Product |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants eligible for inclusion will include non-pregnant adult (>18 years old) with molecular confirmation of COVID-19. [Participants will be eligible in a period of no longer than 72 hours after exposure].
Key exclusion criteria (6 listed)
- Severe infection ( defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support).
- Weight below 40Kg or above 100Kg
- Unable to take oral medication
- Known allergy to the drugs
- Pregnancy or breast feeding
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 |
|---|---|---|
| Ivermectin Oral Product3mg Capsules, 12-15mg/ day for 3 days | Drug | IVERMECTIN, PLACEBO |
Primary outcome
Viral clearance at day 6
Time frame: Outcome will be determined till 6 days post intervention
The primary outcome will be the viral clearance at day 6 in the intervention group compared to placebo.
Viral shedding duration
Time frame: Outcome will be determined till 14 days post intervention
Secondary outcomes: viral shedding duration (time between first positive PCR to last of two consecutive negative tests)
Symptoms clearance time
Time frame: Outcome will be determined till 14 days post intervention
Time between drug treatment and symptoms resolution
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 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.
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 Oral Product in people with COVID-19, run by Sheba Medical Center at 1 site in Israel.
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 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: status not confirmed, as of the sponsor's last update on 16 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 Israel. 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.
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 Eli Schwartz, Prof. (972 3 5308456, Eli.schwartz@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral clearance at day 6 (time frame: Outcome will be determined till 6 days post intervention). The study lists 3 primary outcomes in all. 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 16 Jun 2020.