HealthyPhase 4NCT03690453
Effect of Ivermectin Metabolites on Mosquito Survival
A Phase 4 study testing Ivermectin in people with Healthy, run by University of Oxford at 1 site in Thailand.
Trial summary
This clinical trial will be designed to capture the full duration of mosquito-lethal effect of single dose Ivermectin to aid efforts to characterize metabolites with mosquito-lethal effect. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ivermectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteThailand
- Study dates
- 4 Feb 2019to 5 Apr 2022
- Phase
- Phase 4
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females aged between 18 years to 60 years.
- Males and Females weight between 36-75 kilograms.
- A female is eligible to enter and participate in this study if she is:
- of non-childbearing potential including pre-menopausal females with documented (medical report verification) hysterectomy or double oophorectomy
- or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone levels >40 mIU/mL or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy
Show all 18Show fewer
- or of childbearing potential, has a negative serum pregnancy test at screening and prior to start the study drug in each period, and abstain from sexual intercourse or agrees to using effective contraceptive methods (e.g., intrauterine device, hormonal contraceptive drug, tubal ligation or female barrier method with spermicide) during the study until completion of the follow-up procedures
- A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
- Provide a signed and dated written informed consent prior to study participation.
- Willingness and ability to comply with the study protocol for the duration of the trial.
- Able to tolerate direct mosquito feeding.
- Blood hemoglobin in males >13 g/dL and females >12 g/dL.
- Normal electrocardiogram (ECG) with QTc <450 msec.
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females aged between 18 years to 60 years.
- Males and Females weight between 36-75 kilograms.
- Provide a signed and dated written informed consent prior to study participation.
- Willingness and ability to donate blood.
Who cannot join
- Females who are pregnant, trying to get pregnant, or are lactating.
- A positive hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of sudden cardiac death.
- A creatinine clearance <70 mL/min as determined by Cockcroft-Gault equation:
- Clcr (mL/min) = (140 - age) Wt / (72 Scr) (multiply answer by 0.85 for females) Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Cockcroft, 1976].
- History of alcohol or substance abuse or dependence within 6 months of the study.
Show all 29Show fewer
- The subject has evidence of active substance abuse that may compromise safety, pharmacokinetics, or ability to adhere with protocol instructions
- Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to the first dose of study medication until the completion of the follow-up procedure, unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety; the investigator will take advice from the manufacturer representative as necessary.
- The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of study medication.
- The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to the first dose of study medication until collection of the final pharmacokinetic sample.
- Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period. Plasma donation during the study is not acceptable.
- Subjects who have a history of allergy to IVM, or a history of drug or other allergy that, in the opinion of the investigator, contraindicates participation in the trial. In addition, if heparin is used during pharmacokinetic sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia should not be enrolled.
- Lack of suitability for participation in this study, including but not limited to, unstable medical conditions, systemic disease manifested by tendency to granulocytopenia e.g. rheumatoid arthritis and lupus erythematosus that in the opinion of the investigator would compromise their participation in the trial.
- AST or ALT >1.5 upper limit of normal (ULN)
- Subjects with history of renal disease, hepatic disease, and/or cholecystectomy
- History of IVM or other drug treatments known to be CYP3A4 inducers or inhibitors (e.g. piperaquine, ritonavir, rifampicin) within 3 months.
- The subject is unwilling to abstain from the consumption of food containing vitamin C (e.g. fruits, juices, papaya salad) 12 hours before and after drug ingestion.
- History of travel to West or Central Africa, unless it can be verified that subject does not have Loa loa infection.
- History or suspected of hypersensitivity/anaphylaxis to mosquito bites and other insect bites/sting (e.g. history of cellulitis-like cutaneous inflammation, anaphylaxis, hives)
- Females who are pregnant, trying to get pregnant, or are lactating (determined by verbally asking and urine pregnancy test).
- The subject has evidence of active substance abuse that may compromise safety or ability to adhere with protocol instructions.
- A positive hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- History of alcohol or substance abuse or dependence within 6 months of the study.
- Any known blood disorders (e.g. thalassemia, sickle cell anemia)
- Use of prescription (especially CYP3A4 inhibitors or inducers) or non-prescription drugs except paracetamol at doses of up to 2 grams/day, including vitamins (especially vitamin C), herbal and dietary supplements (including St. John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 times the drug half-life (whichever is longer) prior to blood collection unless in the opinion of investigator, the medication will not interfere with the study procedures or compromise subject safety; the investigator will take advice from the manufacturer representative as necessary.
- The subject has participated in a clinical trial and has received a drug (particularly IVM or any drug known to be a CYP3A4 inducer or inhibitor) or a new chemical entity within 90 days prior to blood collection.
- The subject is unwilling to abstain from ingesting alcohol within 48 hours prior to blood collection.
- The subject is unwilling to abstain from consumption of food containing vitamin C (e.g. fruits, juices, papaya salad within 12 hours prior to blood collection.
- Subjects who have donated blood to the extent that participation in the study would result in more than 300 mL blood donated within a 30-day period.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Hospital for Tropical Diseases, Faculty of Tropical Medicine, Mahidol University
Bangkok, 10400
About this study
Official title: Open-Label Study to Evaluate Pharmacokinetic Properties and Mosquito-Lethal Effect of Ivermectin Metabolites in Healthy Adult Subjects
This clinical trial will be designed to capture the full duration of mosquito-lethal effect of single dose Ivermectin to aid efforts to characterize metabolites with mosquito-lethal effect. Ivermectin and its metabolites likely have antiparasitic properties against asexual and sexual stage Plasmodium parasites that will be investigated with plasma samples from this study.
This is an open-label pharmacokinetic study. Ten healthy participants will be admitted in the inpatient ward to receive a single oral dose of IVM (400 µg/kg).
Read more
Another 10 healthy participants will be donate blood up to 42 ml each times for up to 3 times. There is no drug administration for these participants.
The total duration for each volunteer's participation in the study is approximately 2 months.
Read the detailed description
HEALTHY PARTICIPANT FOR CLINICAL TRIAL
Study will enroll 10 Thai healthy participants, 5 male and 5 female, aged 18-60 years.
Participants will be admitted in the inpatient ward to receive a single oral dose of IVM (400 µg/kg).
After a volunteert has provided written informed consent, the investigator will determine if the volunteer is eligible for enrollment in the study. This will be done by reviewing the inclusion and exclusion criteria and completing all of the screening assessments. Screening assessments may be carried out over more than one day, provided that all required assessments are completed within the 14 days prior to admission for Ivermectin administration.
The blood collection for Standard Membrane Feeding Assay, Direct Feeding Assays, Pharmacokinetic analysis, Plasma for Plasmodium assays and mosquito IgG assays should be obtained at the scheduled times relative to when the participant was dosed.
The total duration for each volunteer's participation in the study is approximately 2 months.
HEALTHY PARTICIPANT FOR BLOOD DONOR
Study will enroll 10 healthy participants, aged 18-60 years. Each participant will donate blood up to 42 ml via venipuncture up to three blood donations. There will be at least 28 days between each blood donation from the same subject.
Blood will be maintained at 37°C in a warm water bath until mixed with ivermectin compounds or metabolites by Pharmacology staff and fed to mosquitoes by Armed Forces Research Institute of Medical Sciences (AFRIMS) staff. Any remaining blood after SMFAs will be discarded. No blood samples will be transferred to AFRIMS. Participants for blood donation should not be the same participants enrolled in the clinical trial above.
- Conditions
- Healthy
- Being tested
- Ivermectin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
single dose of Ivermectin
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteer for Clinical Trial | Experimental | Not described Receives: Drug: Ivermectin |
| Healthy volunteer for blood donor | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve for Ivermectin and its metabolites
Pharmacokinetic parameters (area under the concentration-time curve [(AUC∞ and AUCLAST] for Ivermectin and its metabolites.
Measured: 41 days
Maximum concentration for Ivermectin and its metabolites
Pharmacokinetic parameters (maximum concentration [CMAX]) for Ivermectin and its metabolites.
Measured: 41 days
Time to maximum concentration for Ivermectin and its metabolites
Pharmacokinetic parameters (time to maximum concentration [TMAX]) for Ivermectin and its metabolites.
Measured: 41 days
Terminal elimination half-life for Ivermectin and its metabolites
Pharmacokinetic parameters (terminal elimination half-life [t1/2]) for Ivermectin and its metabolites.
Measured: 41 days
Concentration associated with half maximum mosquito killing effect [LC50] for Ivermectin and its metabolites
Pharmacodynamic parameters (concentration associated with half maximum mosquito killing effect [LC50]) for Ivermectin and its metabolites.
Measured: 41 days
Secondary outcomes (9)
Duration of mosquito survivorship
Duration of mosquito survivorship following standard membrane feeding assay (SMFA) to determine duration of time post drug administration that IVM-treated volunteers are lethal to An. dirus and An. minimus.
Measured: 14 days
Compare Maximum Blood Concentrations (Cmax) for ivermectin components and metabolites measured between venous and capillary blood
Pharmacokinetic differences for Ivermectin and metabolites in venous and capillary blood.
Measured: 41 days
Compare Area-Under-Curve (AUC) for ivermectin components and metabolites measured between venous and capillary blood
Pharmacokinetic differences for Ivermectin and metabolites in venous and capillary blood.
Measured: 41 days
Compare mosquito (An. dirus) survival curves to day 14 between Direct Feeding Assay and Standard Membrane Feeding Assays
Mosquito survival curves to day 14 within a species will be compared between mosquitoes blood fed via Direct Feeding Assay and Standard Membrane Feeding Assays by Log-Rank survival curve analysis (Mantel-Cox method). This will assess if venous blood is more or less lethal to mosquitoes than blood ingested from subdermal capillaries.
Measured: 14 days
Compare mosquito (An. Minimus) survival curves to day 14 between Direct Feeding Assay and Standard Membrane Feeding Assays
Mosquito survival curves to day 14 within a species will be compared between mosquitoes blood fed via Direct Feeding Assay and Standard Membrane Feeding Assays by Log-Rank survival curve analysis (Mantel-Cox method). This will assess if venous blood is more or less lethal to mosquitoes than blood ingested from subdermal capillaries.
Measured: 14 days
The lethal concentration that kills 50% of mosquitoes (LC50) between two strains of An. dirus
The lethal concentration that kills 50% of mosquitoes (LC50) between two strains of An. dirus will be evaluated. This will assess if one An. dirus strain is more or less susceptible to ivermectin.
Measured: 14 days
Mosquito survival curves to day 14 between two strains of An. dirus.
Mosquito survival curves to day 14 between two strains of An. dirus will be evaluated. This will assess if one An. dirus strain is more or less susceptible to ivermectin.
Measured: 14 days
The lethal concentration that kills 50% of mosquitoes (LC50) for each ivermectin component and synthesized metabolites
The lethal concentration that kills 50% of mosquitoes (LC50) for each ivermectin component and synthesized metabolites. The LC50s and their corresponding 95% confidence intervals will be evaluated for each ivermectin component and synthesized metabolites. This will assess if any of the ivermectin components or metabolites are more or less lethal to An. dirus.
Measured: 14 days
The inhibitory concentration that kills 50% of parasites (IC50) for each P. falciparum strain.
The inhibitory concentration that kills 50% of parasites (IC50) will be evaluated for each P. falciparum strain to determine which strains are more or less susceptible to ivermectin.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start4 Feb 2019
- Primary completion5 Apr 2022
- Study completion5 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690453
- Sponsor's protocol ID
- MAL18006
- Status last verified
- Jan 2023
- First submitted
- 18 Sep 2018
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With subject's consent, subject's data and results from blood analyses stored in the database may be shared with other researchers to use in the future.
Publications
Kobylinski KC, Tipthara P, Wamaket N, Chainarin S, Kullasakboonsri R, Sriwichai P, Phasomkusolsil S, Hanboonkunupakarn B, Jittamala P, Gemmell R, Boyle J, Wrigley S, Steele J, White NJ, Tarning J. Author Correction: Ivermectin metabolites reduce Anopheles survival. Sci Rep. 2024 Oct 24;14(1):25243. doi: 10.1038/s41598-024-76902-z. No abstract available.
PubMed 39448768
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate Pharmacokinetic Properties and Mosquito-Lethal Effect of Ivermectin Metabolites in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03690453
- Acronym / sponsor ID
- MAL18006
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 5 Apr 2022 (actual)
- Study completion
- 5 Apr 2022 (actual)
- First posted
- 1 Oct 2018 (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.
This clinical trial will be designed to capture the full duration of mosquito-lethal effect of single dose Ivermectin to aid efforts to characterize metabolites with mosquito-lethal effect. Ivermectin and its metabolites likely have antiparasitic properties against asexual and sexual stage Plasmodium parasites that will be investigated with plasma samples from this study.
This is an open-label pharmacokinetic study. Ten healthy participants will be admitted in the inpatient ward to receive a single oral dose of IVM (400 µg/kg).
Another 10 healthy participants will be donate blood up to 42 ml each times for up to 3 times. There is no drug administration for these participants.
The total duration for each volunteer's participation in the study is approximately 2 months.
Detailed description
HEALTHY PARTICIPANT FOR CLINICAL TRIAL
Study will enroll 10 Thai healthy participants, 5 male and 5 female, aged 18-60 years.
Participants will be admitted in the inpatient ward to receive a single oral dose of IVM (400 µg/kg).
After a volunteert has provided written informed consent, the investigator will determine if the volunteer is eligible for enrollment in the study. This will be done by reviewing the inclusion and exclusion criteria and completing all of the screening assessments. Screening assessments may be carried out over more than one day, provided that all required assessments are completed within the 14 days prior to admission for Ivermectin administration.
The blood collection for Standard Membrane Feeding Assay, Direct Feeding Assays, Pharmacokinetic analysis, Plasma for Plasmodium assays and mosquito IgG assays should be obtained at the scheduled times relative to when the participant was dosed.
The total duration for each volunteer's participation in the study is approximately 2 months.
HEALTHY PARTICIPANT FOR BLOOD DONOR
Study will enroll 10 healthy participants, aged 18-60 years. Each participant will donate blood up to 42 ml via venipuncture up to three blood donations. There will be at least 28 days between each blood donation from the same subject.
Blood will be maintained at 37°C in a warm water bath until mixed with ivermectin compounds or metabolites by Pharmacology staff and fed to mosquitoes by Armed Forces Research Institute of Medical Sciences (AFRIMS) staff. Any remaining blood after SMFAs will be discarded. No blood samples will be transferred to AFRIMS. Participants for blood donation should not be the same participants enrolled in the clinical trial above.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteer for Clinical Trial | Experimental | Drug: Ivermectin |
| Healthy volunteer for blood donor | No intervention | – |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Healthy as judged by a responsible physician with no abnormality identified on a medical evaluation including medical history and physical examination.
- Males and Females aged between 18 years to 60 years.
- Males and Females weight between 36-75 kilograms.
- A female is eligible to enter and participate in this study if she is:
- A male is eligible to enter and participate in this study if he: agrees to abstain from (or use a condom during) sexual intercourse with females of childbearing potential or lactating females; or is willing to use a condom/spermicide, during the study until completion of the follow-up procedures.
Key exclusion criteria (29 listed)
- Females who are pregnant, trying to get pregnant, or are lactating.
- A positive hepatitis B surface antigen, positive hepatitis C antibody, or positive human immunodeficiency virus-1 (HIV-1) antibody result at screening.
- Subjects with a personal history of cardiac disease, symptomatic or asymptomatic arrhythmias, syncopal episodes, or additional risk factors for torsades de pointes (heart failure, hypokalemia) or with a family history of sudden cardiac death.
- A creatinine clearance <70 mL/min as determined by Cockcroft-Gault equation:
- Clcr (mL/min) = (140 - age) Wt / (72 Scr) (multiply answer by 0.85 for females) Where age is in years, weight (wt) is in kg, and serum creatinine (Scr) is in units of mg/dL [Cockcroft, 1976].
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 |
|---|---|---|
| Ivermectinsingle dose of Ivermectin | Drug | Healthy volunteer for Clinical Trial |
Primary outcome
Area under the concentration-time curve for Ivermectin and its metabolites
Time frame: 41 days
Pharmacokinetic parameters (area under the concentration-time curve [(AUC∞ and AUCLAST] for Ivermectin and its metabolites.
Maximum concentration for Ivermectin and its metabolites
Time frame: 41 days
Pharmacokinetic parameters (maximum concentration [CMAX]) for Ivermectin and its metabolites.
Time to maximum concentration for Ivermectin and its metabolites
Time frame: 41 days
Pharmacokinetic parameters (time to maximum concentration [TMAX]) for Ivermectin and its metabolites.
Terminal elimination half-life for Ivermectin and its metabolites
Time frame: 41 days
Pharmacokinetic parameters (terminal elimination half-life [t1/2]) for Ivermectin and its metabolites.
Concentration associated with half maximum mosquito killing effect [LC50] for Ivermectin and its metabolites
Time frame: 41 days
Pharmacodynamic parameters (concentration associated with half maximum mosquito killing effect [LC50]) for Ivermectin and its metabolites.
9 secondary outcomes
Duration of mosquito survivorship
Time frame: 14 days
Compare Maximum Blood Concentrations (Cmax) for ivermectin components and metabolites measured between venous and capillary blood
Time frame: 41 days
Compare Area-Under-Curve (AUC) for ivermectin components and metabolites measured between venous and capillary blood
Time frame: 41 days
Compare mosquito (An. dirus) survival curves to day 14 between Direct Feeding Assay and Standard Membrane Feeding Assays
Time frame: 14 days
Compare mosquito (An. Minimus) survival curves to day 14 between Direct Feeding Assay and Standard Membrane Feeding Assays
Time frame: 14 days
The lethal concentration that kills 50% of mosquitoes (LC50) between two strains of An. dirus
Time frame: 14 days
Mosquito survival curves to day 14 between two strains of An. dirus.
Time frame: 14 days
The lethal concentration that kills 50% of mosquitoes (LC50) for each ivermectin component and synthesized metabolites
Time frame: 14 days
The inhibitory concentration that kills 50% of parasites (IC50) for each P. falciparum strain.
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Results publication: PubMed 39448768Kobylinski KC, Tipthara P, Wamaket N, Chainarin S, Kullasakboonsri R, Sriwichai P, Phasomkusolsil S, Hanboonkunupakarn B, Jittamala P, Gemmell R, Boyle J, Wrigley S, Steele J, White NJ, Tarning J. Author Correction: Ivermectin metabolites reduce Anopheles survival. Sci Rep. 2024 Oct 24;14(1):25243. doi: 10.1038/s41598-024-76902-z. No abstract available.
- Individual participant dataSharing planned: Yes. With subject's consent, subject's data and results from blood analyses stored in the database may be shared with other researchers to use in the future.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ivermectin in people with Healthy, run by University of Oxford at 1 site in Thailand.
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 18 inclusion and 29 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: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Area under the concentration-time curve for Ivermectin and its metabolites (time frame: 41 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03690453, which also lists 1 linked publication.
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 26 Nov 2024.