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

MedinCell

Status and phase: Completed; Phase 2

Conditions: COVID-19

Treatments: Drug: Matching placebo tablets; Drug: Ivermectin Tablets

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05305560

mdc-TTG-CT-002

2021-001938-19 (EudraCT Number)

Details and patient eligibility

About

A multicenter, randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of oral ivermectin tablets versus placebo for COVID-19 prophylaxis

Full 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).

Enrollment: 400 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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400 participants in 2 patient groups, including a placebo group

Active IMP

Experimental group

Treatment:

Drug: Ivermectin Tablets

Placebo

Placebo Comparator group

Treatment:

Drug: Matching placebo tablets