Ivermectin for Post Exposure Prophylaxis of Covid-19

Launched by CLINICAL RESEARCH CENTRE, MALAYSIA · Feb 8, 2022

Keywords

ClinConnect Summary

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 cont...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Asymptomatic individuals exposed to a confirmed positive COVID-19 case within 5 days from the study recruitment day (include household, workplace and social close contact)
• • 2. Aged ≥18 years; male or female
• • 3. No fever with temperature less than 37.5ºC
• • 4. RTK Ag for COVID-19 is negative on the recruitment day.
• 5. For subject who had received COVID-19 vaccination:
• • Any primary series vaccine (eg: Pfizer, Sinovac, AstraZeneca etc) : past 90 days after the second dose
• • Any booster vaccine: past 90 days after the booster dose
• • 6. In women of childbearing potential (18-55 years old), negative pregnancy test and agree to use any contraceptive method up to 7 days after the second dose of IP administration
• • 7. Have access to video and phone call
• • 8. Willing to take 2 doses of study medication (2 days apart between Dose 1 and Dose 2)
• • 9. Willing to comply with all study procedures
• • 10. Able to provide written informed consent
• Exclusion Criteria:
• • 1. Unable to take drugs by mouth
• • 2. History of positive confirmed COVID-19 infection within past 3 months
• • 3. Involved in any COVID-19 vaccine clinical trial
• • 4. Patients with suspected concomitant bacterial, fungal infections, concurrent congestive heart failure prior to initiation of study drug
• • 5. Known case of liver disease (any severity)
• • 6. Alcohol intake more than recommended (2 drinks or more in a day for men and 1 drink or more in a day for women)
• • 7. Mal-absorption syndrome or other clinically significant gastrointestinal disease that may affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative colitis, and others).
• • 8. Pregnant or nursing/breastfeeding women or women planning for pregnancy.
• • 9. Female patients who cannot consent to contraceptive use (any method) from the start of IP administration to 7 days after the second dose of IP administration
• • 10. Male patients whose partner cannot agree to use the contraception method as in 9)
• • 11. Patients with a history of gout or on treatment for gout or hyperuricemia
• • 12. Patients receiving immunosuppressant
• • 13. Patients who have previously received Ivermectin.
• • 14. Patients who are not able to provide written consent.
• • 15. Other patients judged ineligible by the principal investigator or sub-investigator