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NCT04632706

Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19

Completed Phase 1 Results posted Last updated 27 December 2021
What this trial tests

Phase 1 trial testing Ivermectin in Covid19 in 24 participants. Completed in 9 March 2021.

Timeline
22 September 2020
Primary endpoint
9 March 2021
9 March 2021

Quick facts

Lead sponsorMedinCell S.A
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsequential
Maskingdouble
Primary purposeother
Enrollment24
Start date22 September 2020
Primary completion9 March 2021
Estimated completion9 March 2021
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

MedinCell S.A

Who can join

Adults 18 to 45, male only, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetic Concentrations - (Maximum Plasma Concentration [Cmax]) Primary · D1, D2 and D28

Maximum plasma concentration (Cmax)

Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups
GroupValue95% CI
50mcg/kg (Oral)57.2± 28.9
75mcg/kg (Oral)41.7± 73.5
100mcg/kg (Oral)46.5± 53.6
Day 2 (first day on respective dose of active treatment)
GroupValue95% CI
50mcg/kg (Oral)22.3± 32.5
75mcg/kg (Oral)24.4± 42.5
100mcg/kg (Oral)33.2± 62.6
Day 28 (last day of active treatment)
GroupValue95% CI
50mcg/kg (Oral)23.3± 52.8
75mcg/kg (Oral)31.9± 27.6
100mcg/kg (Oral)44.4± 68.8
Pharmacokinetic Concentrations - (Time to Reach Cmax [Tmax]) Primary · D1, D2 and D28

Time to reach Cmax (Tmax)

Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups
GroupValue95% CI
50mcg/kg (Oral)2.53± 36.8
75mcg/kg (Oral)3.03± 50.6
100mcg/kg (Oral)4.8± 47.2
Day 2 (first day on respective dose of active treatment)
GroupValue95% CI
50mcg/kg (Oral)3.82± 36.7
75mcg/kg (Oral)2.85± 38.8
100mcg/kg (Oral)3.23± 34.5
Day 28 (last day of active treatment)
GroupValue95% CI
50mcg/kg (Oral)2.83± 39.2
75mcg/kg (Oral)3.03± 50.7
100mcg/kg (Oral)3.03± 39.4
Pharmacokinetic Concentrations - (Area Under the Plasma Concentration-time Curve From Zero to 24 Hours [AUC0-24hr]) Primary · D1, D2 and D28

area under the plasma concentration-time curve from zero to 24 hours (AUC0-24hr) concentration-time curve from zero to 24 hours (AUC0-24hr)

Day 1 after loading dose of 200mcg/kg (oral) for all active treatment groups
GroupValue95% CI
50mcg/kg (Oral)568± 33.6
75mcg/kg (Oral)449± 62.0
100mcg/kg (Oral)523± 60.5
Day 2 (first day on respective dose of active treatment)
GroupValue95% CI
50mcg/kg (Oral)906± 31.4
75mcg/kg (Oral)779± 53.1
100mcg/kg (Oral)941± 59.0
Day 28 (last day of active treatment)
GroupValue95% CI
50mcg/kg (Oral)1.06± 36.6
75mcg/kg (Oral)1.5± 47.5
100mcg/kg (Oral)1.75± 20.6
Pharmacokinetic Concentrations - (Apparent Terminal Half-Life [T1/2]) Primary · D28

apparent terminal half-life (t1/2)

GroupValue95% CI
50mcg/kg (Oral)102± 60.1
75mcg/kg (Oral)99.2± 47.3
100mcg/kg (Oral)127± 47.2
Safety and Tolerability - Treatment Emergent Adverse Events (TEAEs) Secondary · From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days.

Clinical safety data from adverse event (AE) reporting

Any TEAE
GroupValue95% CI
50mcg/kg (Oral)24
75mcg/kg (Oral)5
100mcg/kg (Oral)2
Matching Placebo (Oral)21
Any serious TEAE
GroupValue95% CI
50mcg/kg (Oral)0
75mcg/kg (Oral)0
100mcg/kg (Oral)0
Matching Placebo (Oral)0
Any TEAE leading to discontinuation - due to Study Medication-related TEAE
GroupValue95% CI
50mcg/kg (Oral)0
75mcg/kg (Oral)0
100mcg/kg (Oral)0
Matching Placebo (Oral)0
Any TEAE leading to discontinuation - other reason
GroupValue95% CI
50mcg/kg (Oral)0
75mcg/kg (Oral)0
100mcg/kg (Oral)1
Matching Placebo (Oral)0
TEAE - mild severity
GroupValue95% CI
50mcg/kg (Oral)24
75mcg/kg (Oral)5
100mcg/kg (Oral)2
Matching Placebo (Oral)20
TEAE - moderate severity
GroupValue95% CI
50mcg/kg (Oral)0
75mcg/kg (Oral)0
100mcg/kg (Oral)0
Matching Placebo (Oral)1
Causality (All TEAEs) - Not related
GroupValue95% CI
50mcg/kg (Oral)21
75mcg/kg (Oral)3
100mcg/kg (Oral)2
Matching Placebo (Oral)20
Causality (All TEAEs) - Related (possibly and probably)
GroupValue95% CI
50mcg/kg (Oral)3
75mcg/kg (Oral)2
100mcg/kg (Oral)0
Matching Placebo (Oral)1

Adverse events — posted to ClinicalTrials.gov

Time frame: From Screening (Day -28) to Follow up visit (Day +42) plus 7 additional days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

50mcg/kg (Oral)
Serious: 0/6 (0%)
Deaths: 0/6
75mcg/kg (Oral)
Serious: 0/6 (0%)
Deaths: 0/6
100mcg/kg (Oral)
Serious: 0/6 (0%)
Deaths: 0/6
Matching Placebo (Oral)
Serious: 0/6 (0%)
Deaths: 0/6
Ivermectin Overall
Serious: 0/18 (0%)
Deaths: 0/18
Total (Ivermectin Overall and Placebo)
Serious: 0/24 (0%)
Deaths: 0/24
Other adverse events (30 terms — click to expand)

ReactionSystem50mcg/kg (Oral)75mcg/kg (Oral)100mcg/kg (Oral)Matching Placebo (Oral)Ivermectin OverallTotal (Ivermectin Overall …
HeadacheNervous system disorders
NauseaGastrointestinal disorders
DizzinessNervous system disorders
LethargyNervous system disorders
RashSkin and subcutaneous tissue disorders
PalpitationsCardiac disorders
SomnolenceNervous system disorders
EpistaxisRespiratory, thoracic and mediastinal disorders
Oropharyngeal painRespiratory, thoracic and mediastinal disorders
DiarrhoeaGastrointestinal disorders
ToothacheGastrointestinal disorders
Chest discomfortGeneral disorders
Oral herpesInfections and infestations
Back injuryInjury, poisoning and procedural complications
Burns first degreeInjury, poisoning and procedural complications
Exposure to communicable diseaseInjury, poisoning and procedural complications
Joint injuryInjury, poisoning and procedural complications
Limb injuryInjury, poisoning and procedural complications
Transaminases increasedInvestigations
Decreased appetiteMetabolism and nutrition disorders
DehydrationMetabolism and nutrition disorders
Muscle twitchingMusculoskeletal and connective tissue disorders
MyalgiaMusculoskeletal and connective tissue disorders
Neck painMusculoskeletal and connective tissue disorders
ParaesthesiaNervous system disorders
CoughRespiratory, thoracic and mediastinal disorders
Nasal congestionRespiratory, thoracic and mediastinal disorders
RhinorrhoeaRespiratory, thoracic and mediastinal disorders
EczemaSkin and subcutaneous tissue disorders
PruritusSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT04632706 adverse events section.

Sponsor's own description

An early stage trial to check how safe and tolerable, as well as how the body handles continuous daily use of Active IMP over 28 days in healthy volunteers.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacological strategies to prevent SARS-CoV-2 infection and treat the early phases of COVID-19.
    Scarabel L, Guardascione M, Dal Bo M, Toffoli G. · · 2021 · cited 12× · PMID 33476760 · DOI 10.1016/j.ijid.2021.01.035

Verify or expand the search:

Other trials of Ivermectin

Trials testing the same drug.

Other recruiting trials for Covid19

Currently open trials in the same condition.

Other MedinCell S.A trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04632706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing