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

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).

Inclusion criteria

• Age between 18 and 65 years, inclusive.
• Body weight >45 kg.
• Body Mass Index >18.5.
• Close contact with a person who has a PCR-confirmed SARS-CoV-2 infection within 5 days before screening.
• Only one member in the same household will be enrolled.
• Participants must be able to give informed consent and comply with the study's scheduled events/visits and study assessments.
• SARS-CoV-2 positive index case must be able to give consent to enable collection of the documented positive PCR test.
• Female participants of childbearing potential must use a highly effective method of contraception for the duration of the trial.

Exclusion criteria

• Pregnant or breast-feeding.
• Participants who have been administered COVID-19 vaccine prior to the inclusion or have a planned vaccination during the duration of the study.
• A positive COVID-19 result (PCR or antigen test) within 8 days of screening.
• 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.
• Hypersensitivity to any component of ivermectin.
• Participants who have been administered ivermectin within 30 days prior to screening.
• Participation in another interventional trial within the last 30 days or 5 half-lives of the IMP of the other trial, whichever comes first.
• Participants with gastrointestinal erosions and ulcers (e.g. erosive esophagitis, stomach ulcers, ulcerative colitis etc.).
• History of neurotoxicity with ivermectin or other para-glycoprotein (p-gp) substrates or inhibitors.
• Current use of monoclonal antibodies for the treatment of COVID-19.