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TerminatedNCT05231603I-CPEPUpdated Oct 18, 2022

Ivermectin for Post Exposure Prophylaxis of Covid-19

A Phase 3 interventional study of Ivermectin and Placebo in COVID-19, sponsored by Clinical Research Centre, Malaysia. Terminated at 10 sites in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-18.

Sponsored by Clinical Research Centre, Malaysia · Phase 3, Interventional, and Prevention

Why this study was terminated
Poor response
Phase
Phase 3
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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)

02

Conditions studied

  • COVID-19

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Keywords

  • Ivermectin
  • Post exposure
  • Prophylaxis
03

In context

COVID-19

7,774 studies on the registry are indexed under COVID-19; 482 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Clinical Research Centre, Malaysia is the lead sponsor of 30 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
50 participants (actual)

Study arms

  • Active comparator
    Treatment group:

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

    Drug: Ivermectin

  • Placebo comparator
    Control group

    Placebo-inactive substance

    Other: Placebo

Interventions

  • DrugIvermectin

    0.4 mg/kg/day-maximum dose is 24 mg.

  • OtherPlacebo

    Similar to drug in term of tablets

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 8 weeks

Secondary outcomes

  1. CT value in Covid-19

    Comparison of the CT value between Ivermectin and placebo group

    Time frame: 14 days

Other outcomes

  1. Adverse effects of Ivermectin

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

    Time frame: 14 days

07

Study locations

10 sites
  • KK Bandar Sg Petani
    Sungai Petani, Kedah 08000, Malaysia
  • KK Bagan Serai
    Bagan Serai, Perak 34300, Malaysia
  • KK Greentown
    Ipoh, Perak 30450, Malaysia
  • KK Karai
    Kuala Kangsar, Perak 31050, Malaysia
  • KK Ayer Tawar
    Sitiawan, Perak 32400, Malaysia
  • KK Tanjung Malim
    Slim River, Perak 35900, Malaysia
  • KK Simpang
    Taiping, Perak 34000, Malaysia
  • KK Tapah
    Tapah, Perak 35000, Malaysia
  • KK Kangar
    Kangar, Perlis 01000, Malaysia
  • KK Seberang Jaya
    Butterworth, Pulau Pinang 13700, Malaysia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2022 to primary completion in May 2022, 3 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2022
First posted
Feb 9, 2022
StartActual
Feb 16, 2022
Primary completionActual
May 31, 2022
CompletionActual
Oct 11, 2022
Last update
Oct 18, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05231603
Lead sponsor
Clinical Research Centre, Malaysia
Collaborators
Hovid Berhad
Responsible party
Sponsor
First posted
Feb 9, 2022
Start date
Feb 16, 2022
Primary completion
May 31, 2022
Completion
Oct 11, 2022
Last update
Oct 18, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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