A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention

NCT05305560
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Phase
Phase 2
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Recruitment status
Completed
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Participants
400
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Lead sponsor
MedinCell S.A
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Start date
2022-03-25
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Number of sites
1
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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
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Acronym
SAIVE
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Short title
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
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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
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Control arm
Placebo
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2022-10-13
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First posted
2022-03-31
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Registry last updated
2024-12-31
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Primary completion date
2022-09-15
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Start date
2022-03-25
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Actual participants
400
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Participants
400
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
1
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
MedinCell S.A
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05305560
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ClinicalTrials.gov ID
NCT05305560
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. COVID-19 Prophylaxis

    Timeframe: From Day 1 to Day 28

    Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28

  1. COVID-19 Symptoms Development

    Timeframe: From Day 1 to Day 28

    Number of symptomatic Participants according to the WHO COVID-18 scale

  2. COVID-19 Prophylaxis Timeframe

    Timeframe: From Day 1 to Day 28

    Time to change from baseline in negative RT-PCR to positive RT-PCR

  3. COVID-19 Hospitalisations

    Timeframe: From Day 1 to Day 56

    Proportion of COVID-19 related hospitalisations

  4. COVID-19 Mortality

    Timeframe: From Day 1 to Day 56

    Proportion of COVID-19 related mortality

  5. To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days

    Timeframe: 56 days

    Descriptive comparison of AE rates and severity/seriousness between IVM and placebo

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No

  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.

  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. Hypersensitivity to any component of ivermectin.
  6. Participants who have been administered ivermectin within 30 days prior to screening.
  7. Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
  8. Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
  9. History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
  10. Current use of monoclonal antibodies for the treatment of COVID-19.
Sources for eligibility
clinicaltrials.gov

  • Medical Center Medic Ltd.Sofia, Bulgaria
Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2021-001938-19
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)