NCT05231603

Ivermectin for Post Exposure Prophylaxis of Covid-19

Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Clinical Research Centre, Malaysia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Post exposure prophylaxis of healthy contacts is among the measures used for outbreak control of several infectious diseases (e.g., pandemic influenza). No agent is known to be effective in preventing COVID-19, but Ivermectin is one of the drugs that have shown antiviral activity against SARS-CoV-2 in the laboratory. This study aims to evaluate the effect of post exposure prophylaxis with Ivermectin after exposure to COVID-19 among the asymptomatic close contacts.

Detailed description

Primary Objective: To assess the efficacy of Ivermectin as post exposure prophylaxis in asymptomatic adults (≥18 years of age) who had close-contact exposure to a confirmed case of COVID-19 patient Secondary Objectives: 1. To compare the viral load (using CT value reading) among close contacts who become positive COVID-19 during follow up period between the Ivermectin and placebo group 2. To assess the adverse effects of Ivermectin within 7 days after each dose Study Population and Sampel Size Asymptomatic adults (≥18 years of age) who had recent history (less than 5 days) of close contact exposure to a confirmed COVID-19 positive patient as per the definition by CDC. In this study, the study teams decide to recruit 150 subjects per group, a total of 300 subjects; 30 subjects in each site (15 Ivermectins, 15 placebos)

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Ivermectin	0.4 mg/kg/day-maximum dose is 24 mg.
OTHER	Placebo	Similar to drug in term of tablets

Timeline

• Start date: 2022-02-16
• Primary completion: 2022-05-31
• Completion: 2022-10-11
• First posted: 2022-02-09
• Last updated: 2022-10-18

Locations

10 sites across 1 country: Malaysia