EUCTR2021-001938-19-BGActive, not recruitingPhase 1
A multicentre randomised, Double-Blind, Placebo-controlled, Study to evaluate the efficAcy and safety of oral IVErmectin tablets in the prevention of COVID-19 (the SAIVE Trial) - SAIVE
MedinCell S.A.0 sites400 target enrollmentStarted: February 10, 2022Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 400
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1.Age between 18 and 65 years, inclusive.
- •2.Body weight >45 kg.
- •3.Body Mass Index >18.5.
- •4.Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
- •5.Only one member in the same household will be enrolled.
- •6.Participants must be able to give informed consent and comply with the study’s scheduled events/visits and study assessments.
- •7.SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
- •8.Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial. Their male partners should also use a contraception method (i.e condom) unless vasectomized. (Refer to section 4.5 Contraception Requirements).
- •9.Male participants must use a contraception method (i.e condom) for the duration of the trial, unless vasectomized. Their female partners, if they are of childbearing potential, must use a highly effective method of contraception. (Refer to section 4.5 Contraception Requirements).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 400
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1.Pregnant or breast-feeding.
- •2.Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
- •3.A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
- •4.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.
- •5.Presence of a known uncontrolled/unstable clinically significant medical condition, considered by the investigator as incompatible with study participation.
- •6.Known history of HIV, HBV and/or HCV.
- •7.Hypersensitivity to any component of ivermectin.
- •8.Participants who have been administered ivermectin within 30 days prior to screening.
- •9.Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
- •10.Having undergone extensive bowel resection which may alter ivermectin absorption.
- •11.Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
- •12.Known or clinically suspected disturbance of the blood-brain-barrier (e.g., ABCB-1 [=MDR1] mutation).
- •13.History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
- •14.Current use of P-gp inhibitor drugs such as amiodarone, azithromycin, ketoconazole, cyclosporine.
- •15.Current use of monoclonal antibodies for the treatment of COVID-19.
- •16.Known drug or alcohol abuse.
- •17.Travel to endemic Loa loa regions within the past 3 months prior to screening (central and western Africa).
- •18.Participants under legal guardianship or trusteeship.
Investigators
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