Ivermectin for Post Exposure Prophylaxis of Covid-19

Phase 3

Terminated

• Conditions: COVID-19
• Interventions: Drug: Ivermectin; Other: Placebo

• Registration Number: NCT05231603
• Lead Sponsor: Clinical Research Centre, Malaysia

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)

Study Timeline

• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-09
• Study Start: 2022-02-16
• Primary Completion: 2022-05-31
• Status Verified: 2022-10
• Study Completion: 2022-10-11
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group:	Ivermectin	Ivermectin 0.4 mg/kg/day (maximum 24 mg)
Control group	Placebo	Placebo-inactive substance

Primary Outcome Measures

Name	Time	Method
Number of Covid-19 cases	8 weeks	Comparison of the number of confirmed COVID-19 cases among the close contacts after exposure to a confirmed case of COVID-19 patient in Ivermectin and placebo group

Secondary Outcome Measures

Name	Time	Method
CT value in Covid-19	14 days	Comparison of the CT value between Ivermectin and placebo group

Trial Locations

Locations (10)

KK Ayer Tawar; 🇲🇾 Sitiawan, Perak, Malaysia

KK Tanjung Malim; 🇲🇾 Slim River, Perak, Malaysia

KK Kangar; 🇲🇾 Kangar, Perlis, Malaysia

KK Tapah; 🇲🇾 Tapah, Perak, Malaysia

KK Bandar Sg Petani; 🇲🇾 Sungai Petani, Kedah, Malaysia

KK Greentown; 🇲🇾 Ipoh, Perak, Malaysia

KK Bagan Serai; 🇲🇾 Bagan Serai, Perak, Malaysia

KK Karai; 🇲🇾 Kuala Kangsar, Perak, Malaysia

KK Simpang; 🇲🇾 Taiping, Perak, Malaysia

KK Seberang Jaya; 🇲🇾 Butterworth, Penang, Malaysia