Clinical trial NCT05231603: Ivermectin for Post Exposure Prophylaxis of Covid-19
Official title: Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Keywords: Ivermectin
Post exposure
Prophylaxis
Lead sponsor: Clinical Research Centre, Malaysia
Sponsor class: OTHER
Collaborators: name: Hovid Berhad
First posted: 2022-02-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double blind, placebo controlled clinical trial
Primary purpose: PREVENTION

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 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)

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

Primary outcomes:
measure: Number of Covid-19 cases
timeFrame: 8 weeks
Secondary outcomes:
measure: CT value in Covid-19
timeFrame: 14 days
Other outcomes:
measure: Adverse effects of Ivermectin
timeFrame: 14 days
Locations:
city: Sungai Petani
country: Malaysia
facility: KK Bandar Sg Petani
state: Kedah
city: Butterworth
country: Malaysia
facility: KK Seberang Jaya
state: Penang
city: Bagan Serai
country: Malaysia
facility: KK Bagan Serai
state: Perak
city: Ipoh
country: Malaysia
facility: KK Greentown
state: Perak
city: Kuala Kangsar
country: Malaysia
facility: KK Karai
state: Perak
city: Sitiawan
country: Malaysia
facility: KK Ayer Tawar
state: Perak
city: Slim River
country: Malaysia
facility: KK Tanjung Malim
state: Perak
city: Taiping
country: Malaysia
facility: KK Simpang
state: Perak
city: Tapah
country: Malaysia
facility: KK Tapah
state: Perak
city: Kangar
country: Malaysia
facility: KK Kangar
state: Perlis
Study officials:
References: