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Efficacy of Ivermectin for the Treatment and Prophylaxis of COVID-19 disease

A Multi-Center, Open-Label, Randomized, Controlled Clinical Trial of the Efficacy of Ivermectin for the Treatment and Prophylaxis of COVID-19

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202102535686338
Enrollment
240
Registered
2021-02-16
Start date
2021-02-22
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Coronavirus disease 2019

Interventions

Oral tablets Ivermectin

Sponsors

Lagos State Ministry of Health
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet all of the following criteria: (1) Provide written informed consent prior to initiation of any study procedures (2) Understand and agree to comply with planned study procedures (3) Agree to the collection of nasopharyngeal swabs, sputum, and venous blood per protocol (4) Be a male or non-pregnant female adult =18 years of age at the time of enrolment (5) Have laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen no more than 7 days prior to randomization OR be a household contact (within 7 days) of an individual with lab positive COVID-19 disease.

Exclusion criteria

Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR < 30) 2. Pregnant or breastfeeding. 3. Anticipated transfer to another facility that is not a study site within 72 hours. 4. Participants with known haematological diseases (G6PD deficiency) 5. Participants with chronic liver and kidney disease and reaching end-stage. 6. Participants with arrhythmia and chronic heart disease. 7. Participants known to have or hearing loss. 8. Participants known to have a mental disability. 9. Skin disorders (including rash, dermatitis, psoriasis). 10. Allergy to Ivermectin or its analogues. 11. Participants known to have filaria.

Design outcomes

Primary

MeasureTime frame
Primary endpoint: 1. Mortality in both groups on day 7 2. Resolution of symptoms assessed by clinical status and daily NEWS score until discharge and on Day 7. 3. SARS-CoV-2 clearance time based on samples taken on Days 1, 4, and 6.

Secondary

MeasureTime frame
Secondary endpoint: 1. Percentage of household contacts of hospitalized COVID-19 patients or other enrolled PCR Negative patients that received oral ivermectin that developed SARS-CoV-2 infection compared to household contacts or other enrolled PCR Negative patients that received no prophylactic therapy on or before day 60. 2. Time to onset of SARS-CoV-2 infection in household contacts of hospitalized COVID-19 patients or other enrolled PCR Negative patients that received oral ivermectin compared to those who received no prophylactic therapy, on or before day 60.

Countries

Nigeria

Contacts

Public ContactHussein Abdurrazzaq

Head Research Unit Lagos State Ministry of Health

haderazz05@ymail.com2348099355417

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026