COVID-19Phase 3I-CPEPNCT05231603
Ivermectin for Post Exposure Prophylaxis of Covid-19
A Phase 3 study testing Ivermectin in people with COVID-19, run by Clinical Research Centre, Malaysia at 10 sites in Malaysia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 10 sitesMalaysia
- Study dates
- 16 Feb 2022to 11 Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Malaysia10 sites
KK Bagan Serai
Bagan Serai, Perak, 34300
KK Seberang Jaya
Butterworth, Pulau Pinang, 13700
KK Greentown
Ipoh, Perak, 30450
KK Kangar
Kangar, Perlis, 01000
KK Karai
Kuala Kangsar, Perak, 31050
KK Ayer Tawar
Sitiawan, Perak, 32400
KK Tanjung Malim
Slim River, Perak, 35900
KK Bandar Sg Petani
Sungai Petani, Kedah, 08000
KK Simpang
Taiping, Perak, 34000
KK Tapah
Tapah, Perak, 35000
About this study
Official title: Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts
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:
- 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)
- Conditions
- COVID-19
- Being tested
- Ivermectin, Placebo
- Keywords
- Ivermectin, Post exposure, Prophylaxis
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
0.4 mg/kg/day-maximum dose is 24 mg.
PlaceboOther
Similar to drug in term of tablets
| Study group | Role | What they receive |
|---|---|---|
| Treatment group: | Active comparator | Ivermectin 0.4 mg/kg/day (maximum 24 mg) Receives: Drug: Ivermectin |
| Control group | Placebo comparator | Placebo-inactive substance Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 weeks
Secondary outcomes (1)
CT value in Covid-19
Comparison of the CT value between Ivermectin and placebo group
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2022
- Study start16 Feb 2022
- Primary completion31 May 2022
- Study completion11 Oct 2022
Why it stopped: Poor response
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double blind, placebo controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Research Centre, Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Hovid Berhad
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05231603
- Sponsor's protocol ID
- NMRR-21-1371-60569
- Acronym
- I-CPEP
- Status last verified
- Oct 2022
- First submitted
- 27 Jan 2022
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Clinical Trial of Ivermectin For Post Exposure Prophylaxis For COVID-19 Infection Among Close Contacts
- ClinicalTrials.gov ID
- NCT05231603
- Acronym / sponsor ID
- I-CPEP / NMRR-21-1371-60569
- Conditions
- COVID-19
- Keywords
- Ivermectin, Post exposure, Prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor response
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Clinical Research Centre, MalaysiaUniversity, hospital or other
- Collaborators
- Hovid Berhad
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 11 Oct 2022 (actual)
- First posted
- 9 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double blind, placebo controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Treatment group: | Active comparator | Drug: IvermectinIvermectin 0.4 mg/kg/day (maximum 24 mg) |
| Control group | Placebo comparator | Other: PlaceboPlacebo-inactive substance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivermectin0.4 mg/kg/day-maximum dose is 24 mg. | Drug | Treatment group: |
| PlaceboSimilar to drug in term of tablets | Other | Control group |
Primary outcome
Number of Covid-19 cases
Time frame: 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
1 secondary outcome
CT value in Covid-19
Time frame: 14 days
Results and safety
The study was stopped early (reason given: Poor response). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ivermectin in people with COVID-19, run by Clinical Research Centre, Malaysia at 10 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Poor response). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Covid-19 cases (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.