Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ivermectin in COVID-19 Prevention (NCT NCT05305560)

NCT ID: NCT05305560

Last Updated: 2024-12-31

Results Overview

Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 400 participants
• Primary outcome timeframe: From Day 1 to Day 28
• Results posted on: 2024-12-31

Participant Flow

Participant milestones

Measure	Active IMP Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo Matching placebo tablets: Daily placebo tablets intake for 28 days
Overall Study STARTED	200	199
Overall Study COMPLETED	200	199
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses

Baseline characteristics by cohort

Measure	Active IMP n=200 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days	Total n=399 Participants Total of all reporting groups
Age, Continuous	40.86 years STANDARD_DEVIATION 11.84 • n=200 Participants	39.99 years STANDARD_DEVIATION 12.03 • n=199 Participants	40.42 years STANDARD_DEVIATION 11.93 • n=399 Participants
Sex: Female, Male Female	81 Participants n=200 Participants • 1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses	90 Participants n=199 Participants • 1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses	171 Participants n=399 Participants • 1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses
Sex: Female, Male Male	119 Participants n=200 Participants • 1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses	109 Participants n=199 Participants • 1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses	228 Participants n=399 Participants • 1 participant who was randomized to placebo did not receive treatment as the IMP Kit was not available at the site. They were not included in the analyses
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Bulgaria	200 participants n=200 Participants	199 participants n=199 Participants	399 participants n=399 Participants

PRIMARY outcome

Timeframe: From Day 1 to Day 28

Number of laboratory-confirmed COVID-19 infections in each group between baseline and Day 28

Outcome measures

Measure	Active IMP n=200 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days
COVID-19 Prophylaxis	30 Participants	105 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 28

Number of symptomatic Participants according to the WHO COVID-18 scale

Outcome measures

Measure	Active IMP n=200 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days
COVID-19 Symptoms Development	28 Participants	97 Participants

SECONDARY outcome

Timeframe: From Day 1 to Day 28

Population: Participants who've had a positive RT-PCR during the trial

Time to change from baseline in negative RT-PCR to positive RT-PCR

Outcome measures

Measure	Active IMP n=30 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=105 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days
COVID-19 Prophylaxis Timeframe	9 days Standard Deviation 1.39	8.10 days Standard Deviation 2.14

SECONDARY outcome

Timeframe: From Day 1 to Day 56

Population: Partcipants who had COVID-19 related hospitalisatoin episodes

Proportion of COVID-19 related hospitalisations

Outcome measures

Measure	Active IMP n=200 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days
COVID-19 Hospitalisations	0 participants	0 participants

SECONDARY outcome

Timeframe: From Day 1 to Day 56

Population: Participants who suffered a COVID-19 related death

Proportion of COVID-19 related mortality

Outcome measures

Measure	Active IMP n=200 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days
COVID-19 Mortality	0 participants	0 participants

SECONDARY outcome

Timeframe: 56 days

Population: All participants who have received at least a single dose of the allocated treatment

Descriptive comparison of AE rates and severity/seriousness between IVM and placebo

Outcome measures

Measure	Active IMP n=200 Participants Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 Participants Matching placebo tablets: Daily placebo tablets intake for 28 days
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days Adverse events	49 participants	109 participants
To Assess the Safety and Tolerability of IVM Given for a Period of 28 Days Serious adverse events	0 participants	0 participants

Adverse Events

Active IMP

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 109 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active IMP n=200 participants at risk Ivermectin Tablets: Daily ivermectin tablets intake for 28 days ; 200 mcg/kg on D1 then 100 mcg/kg daily from D2 to D28.	Placebo n=199 participants at risk Matching placebo tablets: Daily placebo tablets intake for 28 days
Infections and infestations COVID-19	15.0% 30/200 • Number of events 30 • 56 days Adverse events were collected passively upon Participant declaration.	54.8% 109/199 • Number of events 109 • 56 days Adverse events were collected passively upon Participant declaration.
Metabolism and nutrition disorders Hyperlipidemia	0.00% 0/200 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Nervous system disorders Dizziness	0.00% 0/200 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Nervous system disorders Headache	2.0% 4/200 • Number of events 4 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Ear and labyrinth disorders Vertigp	0.50% 1/200 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.	0.00% 0/199 • 56 days Adverse events were collected passively upon Participant declaration.
Cardiac disorders Palpitations	0.00% 0/200 • 56 days Adverse events were collected passively upon Participant declaration.	1.0% 2/199 • Number of events 2 • 56 days Adverse events were collected passively upon Participant declaration.
Gastrointestinal disorders Diarrhoea	2.0% 4/200 • Number of events 4 • 56 days Adverse events were collected passively upon Participant declaration.	0.00% 0/199 • 56 days Adverse events were collected passively upon Participant declaration.
Gastrointestinal disorders Nausea	2.0% 4/200 • Number of events 4 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/200 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Reproductive system and breast disorders Dysmenorrhea	1.0% 2/200 • Number of events 2 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
General disorders Fatigue	1.0% 2/200 • Number of events 2 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Investigations Alanine aminotransferase increased	1.0% 2/200 • Number of events 2 • 56 days Adverse events were collected passively upon Participant declaration.	0.00% 0/199 • 56 days Adverse events were collected passively upon Participant declaration.
Investigations Aspartate aminotransferase increased	1.5% 3/200 • Number of events 3 • 56 days Adverse events were collected passively upon Participant declaration.	0.00% 0/199 • 56 days Adverse events were collected passively upon Participant declaration.
Investigations Basophil count increased	0.00% 0/200 • 56 days Adverse events were collected passively upon Participant declaration.	0.50% 1/199 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.
Investigations Body temperature increased	0.50% 1/200 • Number of events 1 • 56 days Adverse events were collected passively upon Participant declaration.	0.00% 0/199 • 56 days Adverse events were collected passively upon Participant declaration.
Investigations C-reactive protein increased	0.00% 0/200 • 56 days Adverse events were collected passively upon Participant declaration.	2.5% 5/199 • Number of events 5 • 56 days Adverse events were collected passively upon Participant declaration.

Additional Information

Head of Clinical Development

MedinCell

Phone: 6 40 38 93 83

Email: caroline.denot@medincell.com

Results disclosure agreements

• Principal investigator is a sponsor employee The PI can present and discuss the results but publication is subject to the sponsor's prior approval
• Publication restrictions are in place

Restriction type: OTHER