COVID-19Phase 2SAIVENCT05305560
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
A Phase 2 study testing Ivermectin Tablets in people with COVID-19, run by MedinCell S.A at 1 site in Bulgaria.
Trial summary
A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- COVID-19
- What is being tested?
- Ivermectin Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteBulgaria
- Study dates
- 25 Mar 2022to 13 Oct 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years, inclusive.
- Body weight >45 kg.
- Body Mass Index >18.5.
- Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
- Only one member in the same household will be enrolled.
- Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
- SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
- Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.
Who cannot join
- Pregnant or breast-feeding.
- Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
- A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
- Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
- Hypersensitivity to any component of ivermectin.
- Participants who have been administered ivermectin within 30 days prior to screening.
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- Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
- Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
- History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
- Current use of monoclonal antibodies for the treatment of COVID-19.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19
A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
Read the detailed description
This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).
- Conditions
- COVID-19
- Being tested
- Ivermectin Tablets, Matching placebo tablets
- Keywords
- Prophylaxis, RT-PCR test
- 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 TabletsDrug
Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.
Matching placebo tabletsDrug
Daily placebo tablets intake for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Active IMP | Experimental | Not described Receives: Drug: Ivermectin Tablets |
| Placebo | Placebo comparator | Not described Receives: Drug: Matching placebo tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 Prophylaxis
Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28
Measured: From Day 1 to Day 28
Secondary outcomes (5)
COVID-19 Symptoms Development
Number of symptomatic Participants according to the WHO COVID-18 scale
Measured: From Day 1 to Day 28
COVID-19 Prophylaxis Timeframe
Time to change from baseline in negative RT-PCR to positive RT-PCR
Measured: From Day 1 to Day 28
COVID-19 Hospitalisations
Proportion of COVID-19 related hospitalisations
Measured: From Day 1 to Day 56
COVID-19 Mortality
Proportion of COVID-19 related mortality
Measured: From Day 1 to Day 56
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days
Descriptive comparison of AE rates and severity/seriousness between IVM and placebo
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start25 Mar 2022
- Primary completion15 Sep 2022
- Study completion13 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedinCell S.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Violaine Desort-Hénin, DVM
- Responsible party
- Sponsor
- Investigators
- Anna Kostova, MD, Principal investigator, Medical Center Medic Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305560
- Sponsor's protocol ID
- mdc-TTG-CT-002
- Other IDs
- 2021-001938-19
- Acronym
- SAIVE
- Status last verified
- Dec 2024
- First submitted
- 28 Mar 2022
- Last updated
- 31 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomised, Double-Blind, Placebo-controlled, Study to Evaluate the efficAcy and Safety of Oral IVErmectin Tablets in the Prevention of COVID-19
- ClinicalTrials.gov ID
- NCT05305560
- Acronym / sponsor ID
- SAIVE / mdc-TTG-CT-002
- Conditions
- COVID-19
- Keywords
- Prophylaxis, RT-PCR test
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- MedinCell S.AIndustry (pharma, biotech, devices)
- Collaborators
- Violaine Desort-Hénin, DVM
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 13 Oct 2022 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Posted 10 Dec 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis
Detailed description
This trial comprises a total observation period of up to 56 days (an on-treatment period of up to 28 days and a safety follow-up of up to 28 days).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active IMP | Experimental | Drug: Ivermectin Tablets |
| Placebo | Placebo comparator | Drug: Matching placebo tablets |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 65 years, inclusive.
- Body weight >45 kg.
- Body Mass Index >18.5.
- Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
- Only one member in the same household will be enrolled.
Key exclusion criteria (10 listed)
- Pregnant or breast-feeding.
- Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
- A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
- Presence of typical COVID-19 symptoms (fever >38°C, SpO2 below 93%, dyspnoea, difficulty breathing, chills, repeated shaking with chills, ageusia, anosmia, cough, myalgia, headache) in the past 48 hours prior to screening.
- Hypersensitivity to any component of ivermectin.
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 TabletsDaily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28. | Drug | Active IMP |
| Matching placebo tabletsDaily placebo tablets intake for 28 days | Drug | Placebo |
Primary outcome
COVID-19 Prophylaxis
Time frame: From Day 1 to Day 28
Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28
5 secondary outcomes
COVID-19 Symptoms Development
Time frame: From Day 1 to Day 28
COVID-19 Prophylaxis Timeframe
Time frame: From Day 1 to Day 28
COVID-19 Hospitalisations
Time frame: From Day 1 to Day 56
COVID-19 Mortality
Time frame: From Day 1 to Day 56
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days
Time frame: 56 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anna Kostova, MD principal investigator
Medical Center Medic Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivermectin Tablets in people with COVID-19, run by MedinCell S.A at 1 site in Bulgaria.
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 8 inclusion and 10 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 31 Dec 2024. 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 Bulgaria. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
COVID-19 Prophylaxis (time frame: From Day 1 to Day 28). 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 31 Dec 2024.