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Ivermectin for Post Exposure Prophylaxis of Covid-19 (I-CPEP)

Primary Purpose

COVID-19

Status
Terminated
Phase
Phase 3
Locations
Malaysia
Study Type
Interventional
Intervention
Ivermectin
Placebo
Sponsored by
Clinical Research Centre, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring Ivermectin, Post exposure, Prophylaxis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • KK Bandar Sg Petani
  • KK Seberang Jaya
  • KK Bagan Serai
  • KK Greentown
  • KK Karai
  • KK Ayer Tawar
  • KK Tanjung Malim
  • KK Simpang
  • KK Tapah
  • KK Kangar

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Treatment group:

Control group

Arm Description

Ivermectin 0.4 mg/kg/day (maximum 24 mg)

Placebo-inactive substance

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

CT value in Covid-19
Comparison of the CT value between Ivermectin and placebo group

Full Information

First Posted
January 27, 2022
Last Updated
October 14, 2022
Sponsor
Clinical Research Centre, Malaysia
Collaborators
Hovid Berhad
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1. Study Identification

Unique Protocol Identification Number
NCT05231603
Brief Title
Ivermectin for Post Exposure Prophylaxis of Covid-19
Acronym
I-CPEP
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
Poor response
Study Start Date
February 16, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
October 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinical Research Centre, Malaysia
Collaborators
Hovid Berhad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Ivermectin, Post exposure, Prophylaxis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized, double blind, placebo controlled clinical trial
Masking
ParticipantInvestigator
Masking Description
This is a randomized, double blind, placebo controlled clinical trial evaluating the effect of Ivermectin for post exposure prophylaxis among close contacts of COVID-19 positive case patient as an index case.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group:
Arm Type
Active Comparator
Arm Description
Ivermectin 0.4 mg/kg/day (maximum 24 mg)
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Placebo-inactive substance
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Intervention Description
0.4 mg/kg/day-maximum dose is 24 mg.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Similar to drug in term of tablets
Primary Outcome Measure Information:
Title
Number of Covid-19 cases
Description
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
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
CT value in Covid-19
Description
Comparison of the CT value between Ivermectin and placebo group
Time Frame
14 days
Other Pre-specified Outcome Measures:
Title
Adverse effects of Ivermectin
Description
To assess the adverse effects of Ivermectin within 7 days after each dose
Time Frame
14 days

10. Eligibility

Sex
All
Gender Based
Yes
Gender Eligibility Description
Male and Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Facility Information:
Facility Name
KK Bandar Sg Petani
City
Sungai Petani
State/Province
Kedah
ZIP/Postal Code
08000
Country
Malaysia
Facility Name
KK Seberang Jaya
City
Butterworth
State/Province
Penang
ZIP/Postal Code
13700
Country
Malaysia
Facility Name
KK Bagan Serai
City
Bagan Serai
State/Province
Perak
ZIP/Postal Code
34300
Country
Malaysia
Facility Name
KK Greentown
City
Ipoh
State/Province
Perak
ZIP/Postal Code
30450
Country
Malaysia
Facility Name
KK Karai
City
Kuala Kangsar
State/Province
Perak
ZIP/Postal Code
31050
Country
Malaysia
Facility Name
KK Ayer Tawar
City
Sitiawan
State/Province
Perak
ZIP/Postal Code
32400
Country
Malaysia
Facility Name
KK Tanjung Malim
City
Slim River
State/Province
Perak
ZIP/Postal Code
35900
Country
Malaysia
Facility Name
KK Simpang
City
Taiping
State/Province
Perak
ZIP/Postal Code
34000
Country
Malaysia
Facility Name
KK Tapah
City
Tapah
State/Province
Perak
ZIP/Postal Code
35000
Country
Malaysia
Facility Name
KK Kangar
City
Kangar
State/Province
Perlis
ZIP/Postal Code
01000
Country
Malaysia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ivermectin for Post Exposure Prophylaxis of Covid-19

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