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

• Sponsor: MedinCell S.A (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05305560
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 5.3
• Patients Per Site Per Month: 76.1

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Drug: Ivermectin Tablets; Drug: Matching placebo tablets	Phase 2

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

• Study Type: Interventional
• Anticipated Enrollment: 400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: 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
• Actual Study Start Date: Mar 25, 2022
• Anticipated Primary Completion Date: Aug 1, 2022
• Anticipated Study Completion Date: Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. COVID-19 prophylaxis [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 [From Day 1 to Day 28]

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

2. COVID-19 symptoms development [From Day 1 to Day 28]

   Change from baseline in the WHO-COVID 19 and NEWS-2 scores

3. COVID-19 symptoms development timeframe [From Day 1 to Day 28]

   Time to change from baseline to first COVID-19 related clinical events

4. COVID-19 hospitalisations [From Day 1 to Day 56]

   Proportion of COVID-19 related hospitalisations

5. COVID-19 mortality [From Day 1 to Day 56]

   Proportion of COVID-19 related mortality

6. Safety and tolerability [From Day 1 to Day 56]

   Safety and Tolerability of ivermectin based on TEAEs and SAEs

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Center Medic Ltd.	Sofia		Bulgaria

Sponsors and Collaborators

• MedinCell S.A

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MedinCell S.A
• ClinicalTrials.gov Identifier: NCT05305560
• Other Study ID Numbers: mdc-TTG-CT-002; 2021-001938-19
• First Posted: Mar 31, 2022
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• 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
• Keywords provided by MedinCell S.A: Prophylaxis; RT-PCR test
• Additional relevant MeSH terms: COVID-19; Ivermectin

Study Results

No Results Posted as of Mar 31, 2022