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

COVID-19 Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05305560
• Other study ID #: mdc-TTG-CT-002
• Secondary ID: 2021-001938-19
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2022
• Est. completion date: October 13, 2022

Study information

• Verified date: January 2023
• Source: MedinCell S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 13, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• 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.
• Matching placebo tablets
Daily placebo tablets intake for 28 days

Locations

Country	Name	City	State
Bulgaria	Medical Center Medic Ltd.	Sofia

Sponsors (2)

Lead Sponsor	Collaborator
MedinCell S.A	Violaine Desort-Hénin, DVM

Country where clinical trial is conducted

Bulgaria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	COVID-19 prophylaxis	Proportion of laboratory-confirmed COVID-19 infections between baseline and Day 28	From Day 1 to Day 28
Secondary	COVID-19 prophylaxis timeframe	Time to change from baseline in negative RT-PCR to positive RT-PCR	From Day 1 to Day 28
Secondary	COVID-19 symptoms development	Change from baseline in the WHO-COVID 19 and NEWS-2 scores	From Day 1 to Day 28
Secondary	COVID-19 symptoms development timeframe	Time to change from baseline to first COVID-19 related clinical events	From Day 1 to Day 28
Secondary	COVID-19 hospitalisations	Proportion of COVID-19 related hospitalisations	From Day 1 to Day 56
Secondary	COVID-19 mortality	Proportion of COVID-19 related mortality	From Day 1 to Day 56
Secondary	Safety and tolerability	Safety and Tolerability of ivermectin based on TEAEs and SAEs	From Day 1 to Day 56