Trial Outcomes & Findings for Loiasis Cross-reactive Antigenemia and Treatment-related Adverse Events (NCT NCT05085665)

NCT ID: NCT05085665

Last Updated: 2022-09-29

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 41 participants
• Primary outcome timeframe: 7 days
• Results posted on: 2022-09-29

Participant Flow

potential participants were identified via screening for daytime L. loa Mf counts in communities in the Awae Health District

41 participants were enrolled; 2 were excluded at the initial study visit: one for L. loa Mf counts >20,000 / mL blood and one due to concerns for significant past medical history

Participant milestones

Measure	Ivermectin All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg
Overall Study STARTED	41
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Ivermectin All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg
Overall Study Physician Decision	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ivermectin n=39 Participants All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg
Age, Continuous	50 years n=39 Participants
Sex: Female, Male Female	13 Participants n=39 Participants
Sex: Female, Male Male	26 Participants n=39 Participants
Region of Enrollment Cameroon	39 Participants n=39 Participants

PRIMARY outcome

Timeframe: 7 days

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

Outcome measures

Measure	Ivermectin n=39 Participants All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg
Cross-reactive Antigenemia	12 Participants

Adverse Events

Ivermectin

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ivermectin n=39 participants at risk All eligible participants received a single dose (150 ug/kg) ivermectin by mouth Ivermectin: single dose, 150 ug/kg
General disorders asthenia	33.3% 13/39 • Number of events 13 • Adverse events were assessed on days 1 - 7 post-treatment
General disorders fever	17.9% 7/39 • Number of events 7 • Adverse events were assessed on days 1 - 7 post-treatment
Skin and subcutaneous tissue disorders itching	28.2% 11/39 • Number of events 11 • Adverse events were assessed on days 1 - 7 post-treatment
Skin and subcutaneous tissue disorders rash	5.1% 2/39 • Number of events 2 • Adverse events were assessed on days 1 - 7 post-treatment
Eye disorders blurry vision	10.3% 4/39 • Number of events 4 • Adverse events were assessed on days 1 - 7 post-treatment
Gastrointestinal disorders decreased appetite	12.8% 5/39 • Number of events 5 • Adverse events were assessed on days 1 - 7 post-treatment
Gastrointestinal disorders diarrhea	20.5% 8/39 • Number of events 8 • Adverse events were assessed on days 1 - 7 post-treatment
Gastrointestinal disorders vomiting	5.1% 2/39 • Number of events 2 • Adverse events were assessed on days 1 - 7 post-treatment
Musculoskeletal and connective tissue disorders back pain	17.9% 7/39 • Number of events 7 • Adverse events were assessed on days 1 - 7 post-treatment
Gastrointestinal disorders abdominal pain	12.8% 5/39 • Number of events 5 • Adverse events were assessed on days 1 - 7 post-treatment
General disorders headache	28.2% 11/39 • Number of events 11 • Adverse events were assessed on days 1 - 7 post-treatment
Musculoskeletal and connective tissue disorders myalgia	7.7% 3/39 • Number of events 3 • Adverse events were assessed on days 1 - 7 post-treatment
General disorders lightheadedness	12.8% 5/39 • Number of events 5 • Adverse events were assessed on days 1 - 7 post-treatment
Respiratory, thoracic and mediastinal disorders cough	25.6% 10/39 • Number of events 10 • Adverse events were assessed on days 1 - 7 post-treatment
Respiratory, thoracic and mediastinal disorders dyspnea	5.1% 2/39 • Number of events 2 • Adverse events were assessed on days 1 - 7 post-treatment
Immune system disorders adenopathy	5.1% 2/39 • Number of events 2 • Adverse events were assessed on days 1 - 7 post-treatment

Additional Information

Dr. Philip Budge

Washington University in St. Louis

Phone: 314-747-5532

Email: pbudge@wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place