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History of Changes for Study: NCT05305560
A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention (SAIVE)
Latest version (submitted January 20, 2023) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 30, 2022 None (earliest Version on record)
2 January 5, 2023 Recruitment Status, Study Status, Contacts/Locations and Study Design
3 January 6, 2023 Study Design and Study Status
4 January 10, 2023 Study Status
5 January 16, 2023 Contacts/Locations and Study Status
6 January 18, 2023 Sponsor/Collaborators and Study Status
7 January 20, 2023 Contacts/Locations and Study Status
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Study NCT05305560
Submitted Date:  March 30, 2022 (v1)
Open or close this module Study Identification
Unique Protocol ID: mdc-TTG-CT-002
Brief Title: A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention (SAIVE)
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
Secondary IDs: 2021-001938-19 [EudraCT Number]
Open or close this module Study Status
Record Verification: March 2022
Overall Status: Recruiting
Study Start: March 25, 2022
Primary Completion: August 2022 [Anticipated]
Study Completion: September 2022 [Anticipated]
First Submitted: March 28, 2022
First Submitted that
Met QC Criteria:		 March 30, 2022
First Posted: March 31, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:		 March 30, 2022
Last Update Posted: March 31, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: MedinCell S.A
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
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).
Open or close this module Conditions
Conditions: COVID-19
Keywords: Prophylaxis
RT-PCR test
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: Triple (Participant, Care Provider, Investigator)
Allocation: Randomized
Enrollment: 400 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Active IMP Drug: Ivermectin Tablets
Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.
Placebo Comparator: Placebo Drug: Matching placebo tablets
Daily placebo tablets intake for 28 days
Open or close this module Outcome Measures
Primary Outcome Measures:
1. COVID-19 prophylaxis
[ Time Frame: From Day 1 to Day 28 ]

Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28
Secondary Outcome Measures:
1. 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
2. COVID-19 symptoms development
[ Time Frame: From Day 1 to Day 28 ]

Change from baseline in the WHO-COVID 19 and NEWS-2 scores
3. 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
4. COVID-19 hospitalisations
[ Time Frame: From Day 1 to Day 56 ]

Proportion of COVID-19 related hospitalisations
5. COVID-19 mortality
[ Time Frame: From Day 1 to Day 56 ]

Proportion of COVID-19 related mortality
6. Safety and tolerability
[ Time Frame: From Day 1 to Day 56 ]

Safety and Tolerability of ivermectin based on TEAEs and SAEs
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 65 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
Open or close this module Contacts/Locations
Central Contact Person: Joël Richard, PhD
Email: joel.richard@medincell.com
Study Officials: Anna Kostova, MD
Principal Investigator
Medical Center Medic Ltd.
Locations: Bulgaria
Medical Center Medic Ltd.
[Recruiting]
Sofia, Bulgaria
Contact:Contact: Anna Kostova, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:
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