Status:
TERMINATED
Ivermectin for Post Exposure Prophylaxis of Covid-19
Lead Sponsor:
Clinical Research Centre, Malaysia
Collaborating Sponsors:
Hovid Berhad
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
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 ...
Eligibility Criteria
Inclusion
- 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)
- Aged ≥18 years; male or female
- No fever with temperature less than 37.5ºC
- RTK Ag for COVID-19 is negative on the recruitment day.
- 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
- 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
- Have access to video and phone call
- Willing to take 2 doses of study medication (2 days apart between Dose 1 and Dose 2)
- Willing to comply with all study procedures
- Able to provide written informed consent
Exclusion
- Unable to take drugs by mouth
- History of positive confirmed COVID-19 infection within past 3 months
- Involved in any COVID-19 vaccine clinical trial
- Patients with suspected concomitant bacterial, fungal infections, concurrent congestive heart failure prior to initiation of study drug
- Known case of liver disease (any severity)
- Alcohol intake more than recommended (2 drinks or more in a day for men and 1 drink or more in a day for women)
- 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).
- Pregnant or nursing/breastfeeding women or women planning for pregnancy.
- 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
- Male patients whose partner cannot agree to use the contraception method as in 9)
- Patients with a history of gout or on treatment for gout or hyperuricemia
- Patients receiving immunosuppressant
- Patients who have previously received Ivermectin.
- Patients who are not able to provide written consent.
- Other patients judged ineligible by the principal investigator or sub-investigator
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 11 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05231603
Start Date
February 16 2022
End Date
October 11 2022
Last Update
October 18 2022
Active Locations (10)
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1
KK Bandar Sg Petani
Sungai Petani, Kedah, Malaysia, 08000
2
KK Bagan Serai
Bagan Serai, Perak, Malaysia, 34300
3
KK Greentown
Ipoh, Perak, Malaysia, 30450
4
KK Karai
Kuala Kangsar, Perak, Malaysia, 31050