Ivermectin for Post Exposure Prophylaxis of Covid-19

COVID-19 Clinical Trial

— I-CPEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05231603
• Other study ID #: NMRR-21-1371-60569
• Status: Terminated
• Phase: Phase 3
• Start date: February 16, 2022
• Est. completion date: October 11, 2022

Study information

• Verified date: October 2022
• Source: Clinical Research Centre, Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: October 11, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Drug:
• Ivermectin
0.4 mg/kg/day-maximum dose is 24 mg.

Other:
• Placebo
Similar to drug in term of tablets

Locations

Country	Name	City	State
Malaysia	KK Bagan Serai	Bagan Serai	Perak
Malaysia	KK Seberang Jaya	Butterworth	Penang
Malaysia	KK Greentown	Ipoh	Perak
Malaysia	KK Kangar	Kangar	Perlis
Malaysia	KK Karai	Kuala Kangsar	Perak
Malaysia	KK Ayer Tawar	Sitiawan	Perak
Malaysia	KK Tanjung Malim	Slim River	Perak
Malaysia	KK Bandar Sg Petani	Sungai Petani	Kedah
Malaysia	KK Simpang	Taiping	Perak
Malaysia	KK Tapah	Tapah	Perak

Sponsors (2)

Lead Sponsor	Collaborator
Clinical Research Centre, Malaysia	Hovid Berhad

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse effects of Ivermectin	To assess the adverse effects of Ivermectin within 7 days after each dose	14 days
Primary	Number of Covid-19 cases	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	8 weeks
Secondary	CT value in Covid-19	Comparison of the CT value between Ivermectin and placebo group	14 days