Study on the effects of using ivermectin to prevent COVID-19 in an adult population in Brazil

Investigation of efficacy and safety for Preventing COVID-19 using a single dose of Ivermectin (IvermecPrev-Brazil) in the general asymptomatic susceptible population under SARS-CoV-2 exposition during a pandemic period in Brazil: randomized double-blind placebo-controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90437126

Enrollment

800

Registered

2020-11-17

Start date

2020-09-15

Completion date

Unknown

Last updated

2022-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of COVID-19 (SARS-CoV-2 infection) Infections and Infestations

Interventions

Study participants eligible for treatment will be randomly assigned to receive single, oral doses of placebo or ivermectin using a computer-generated stratified block randomization code. The random al

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult participants susceptible to be infected by SARS-CoV-19 (not previous infection) tested negative for IgM and IgG immunological test 2. No symptoms of COVID-19 3. Written informed consent signed by participating for the study

Exclusion criteria

Exclusion criteria: 1. Pregnant or breastfeeding 2. Known allergy to study medications used at intervention 3. Known or reported history of liver disease 4. Use of coumarin (anticoagulant)

Design outcomes

Primary

Measure	Time frame
Covid-19 case diagnosis (conversion from being asymptomatic pre-treatment to symptomatic post-treatment for COVID-19) by using a questionnaire for screening clinical symptoms of COVID-19, at baseline, and during the follow up at 7, 14, 30 and 90 days . All clinically diagnosed COVID-19 cases will be confirmed by serologic IgM and IgG anti-SARS-CoV2 test at 14 days post-initial symptoms.	—

Secondary

Measure	Time frame
1. Clinical status of COVID-19 using the WHO Clinical Progression Scale measured at 14 and 30 days after COVID-19 diagnosis (if applicable) 2. Incidence of severe COVID-19 cases determined by active cases detection and defined by WHO Clinical Progression Scale at days 14 and 30 after treatment 3. Rate of adverse events using active case detection with questionnaire and adverse events grades (mild, moderate and severe) using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at days 2 and 7 after treatment 4. Hospitalization rate at 7,14, 30 and 90 days measured using patient records 5. Deaths at the follow-up period (90 days) measured using patient records	—

Measure

Time frame

1. Clinical status of COVID-19 using the WHO Clinical Progression Scale measured at 14 and 30 days after COVID-19 diagnosis (if applicable) 2. Incidence of severe COVID-19 cases determined by active cases detection and defined by WHO Clinical Progression Scale at days 14 and 30 after treatment 3. Rate of adverse events using active case detection with questionnaire and adverse events grades (mild, moderate and severe) using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 at days 2 and 7 after treatment 4. Hospitalization rate at 7,14, 30 and 90 days measured using patient records 5. Deaths at the follow-up period (90 days) measured using patient records

—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026