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

• ClinicalTrials.gov Identifier: NCT05305560
• Recruitment Status: Completed
• First Posted: March 31, 2022
• Last Update Posted: January 23, 2023
• Sponsor: MedinCell S.A
• Collaborator: Violaine Desort-Hénin, DVM
• Information provided by (Responsible Party): MedinCell S.A

Tracking Information

• First Submitted Date: March 28, 2022
• First Posted Date: March 31, 2022
• Last Update Posted Date: January 23, 2023
• Actual Study Start Date: March 25, 2022
• Actual Primary Completion Date: September 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2022)

COVID-19 prophylaxis [ Time Frame: From Day 1 to Day 28 ]

Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 30, 2022)

• COVID-19 prophylaxis timeframe [ Time Frame: From Day 1 to Day 28 ]
  Time to change from baseline in negative RT-PCR to positive RT-PCR
• COVID-19 symptoms development [ Time Frame: From Day 1 to Day 28 ]
  Change from baseline in the WHO-COVID 19 and NEWS-2 scores
• COVID-19 symptoms development timeframe [ Time Frame: From Day 1 to Day 28 ]
  Time to change from baseline to first COVID-19 related clinical events
• COVID-19 hospitalisations [ Time Frame: From Day 1 to Day 56 ]
  Proportion of COVID-19 related hospitalisations
• COVID-19 mortality [ Time Frame: From Day 1 to Day 56 ]
  Proportion of COVID-19 related mortality
• Safety and tolerability [ Time Frame: From Day 1 to Day 56 ]
  Safety and Tolerability of ivermectin based on TEAEs and SAEs

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention
• 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
• Brief 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
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: COVID-19

Intervention

• Drug: Ivermectin Tablets
  Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.
• Drug: Matching placebo tablets
  Daily placebo tablets intake for 28 days

Study Arms

• Experimental: Active IMP
  Intervention: Drug: Ivermectin Tablets
• Placebo Comparator: Placebo
  Intervention: Drug: Matching placebo tablets

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 30, 2022): 400
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: October 13, 2022
• Actual Primary Completion Date: September 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

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. 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Bulgaria

Administrative Information

• NCT Number: NCT05305560
• Other Study ID Numbers: mdc-TTG-CT-002; 2021-001938-19 ( EudraCT Number )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: MedinCell S.A
• Original Responsible Party: Same as current
• Current Study Sponsor: MedinCell S.A
• Original Study Sponsor: Same as current
• Collaborators: Violaine Desort-Hénin, DVM

Investigators

• Principal Investigator: Anna Kostova, MD; Medical Center Medic Ltd.

• PRS Account: MedinCell S.A
• Verification Date: January 2023