I-CPEP: Ivermectin for Post Exposure Prophylaxis of Covid-19

Sponsor
Clinical Research Centre, Malaysia (Other)
Overall Status
Recruiting
CT.gov ID
NCT05231603
Collaborator
Hovid Berhad (Industry)
300
10
2
4.4
30
6.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, double blind, placebo controlled clinical trialRandomized, double blind, placebo controlled clinical trial
Masking:
Double (Participant, Investigator)
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.
Primary Purpose:
Prevention
Official Title:
Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts
Actual Study Start Date :
Feb 16, 2022
Anticipated Primary Completion Date :
May 31, 2022
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Treatment group:

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

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

Placebo Comparator: Control group

Placebo-inactive substance

Other: Placebo
Similar to drug in term of tablets

Outcome Measures

Primary Outcome Measures

  1. 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

  1. CT value in Covid-19 [14 days]

    Comparison of the CT value between Ivermectin and placebo group

Other Outcome Measures

  1. Adverse effects of Ivermectin [14 days]

    To assess the adverse effects of Ivermectin within 7 days after each dose

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

  1. 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

  2. Have access to video and phone call

  3. Willing to take 2 doses of study medication (2 days apart between Dose 1 and Dose 2)

  4. Willing to comply with all study procedures

  5. 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 KK Bandar Sg Petani Sungai Petani Kedah Malaysia 08000
2 KK Seberang Jaya Butterworth Penang Malaysia 13700
3 KK Bagan Serai Bagan Serai Perak Malaysia 34300
4 KK Greentown Ipoh Perak Malaysia 30450
5 KK Karai Kuala Kangsar Perak Malaysia 31050
6 KK Ayer Tawar Sitiawan Perak Malaysia 32400
7 KK Tanjung Malim Slim River Perak Malaysia 35900
8 KK Simpang Taiping Perak Malaysia 34000
9 KK Tapah Tapah Perak Malaysia 35000
10 KK Kangar Kangar Perlis Malaysia 01000

Sponsors and Collaborators

  • Clinical Research Centre, Malaysia
  • Hovid Berhad

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Clinical Research Centre, Malaysia
ClinicalTrials.gov Identifier:
NCT05231603
Other Study ID Numbers:
  • NMRR-21-1371-60569
First Posted:
Feb 9, 2022
Last Update Posted:
Apr 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Clinical Research Centre, Malaysia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 11, 2022