LoiasisPhase 4NCT05085665
Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events
A Phase 4 study testing Ivermectin in people with Loiasis, run by Washington University School of Medicine at 1 site in Cameroon.
Trial summary
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Loiasis
- What is being tested?
- Ivermectin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteCameroon
- Study dates
- 30 Jul 2021to 30 Sep 2021
- Phase
- Phase 4
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Loa loa blood microfilariae of between 5,000 - 18,000 per mL
Who cannot join
- known allergy to ivermectin; severe comorbidities
Trial locations and contacts
1 site in 1 country.
Cameroon1 site
Centre de Recherche sur les Filarioses et autres Maladies Tropicales (CRFilMT)
Yaoundé
About this study
This study seeks to determine which Loa loa antigens are released into circulation when infected individuals are treated with ivermectin.
Read the detailed description
A cohort of up to 50 participants with Loa loa microfilarial levels between 5,000 and 18,000 per ml/blood will be treated with ivermectin in an inpatient setting. Participants will be monitored for treatment-related adverse events for seven days post-treatment, and will have blood drawn on days 0, 1, 2, 3, and 7 post-treatment to assess for microfilarial load, cytokine, and antigen levels.
- Conditions
- Loiasis
- Being tested
- Ivermectin
- Medical subject headings
- Loiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
single dose, 150 ug/kg
| Study group | Role | What they receive |
|---|---|---|
| Ivermectin | Experimental | All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Receives: Drug: Ivermectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-reactive Antigenemia
N of participants with detectable Loa loa antigens in sera that cross-react with diagnostic tests for lymphatic filariasis (Filariasis Test Strip) on either day 1, 2, 3, or 7 post-treatment
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start30 Jul 2021
- Primary completion31 Aug 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LoiasisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Research on Filariasis and Other Tropical Diseases, Cameroon
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085665
- Sponsor's protocol ID
- 201909003(2)
- Status last verified
- Aug 2022
- First submitted
- 7 Oct 2021
- Last updated
- 29 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided