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35 PMExploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 - Study Results - ClinicalTrials.govPage 1 of 21https://clinicaltrials.gov/ct2/show/results/NCT04632706
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ClinicalTrials.gov Identifier: NCT04632706
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ort.Exploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19COVID-19 Information
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1/10/22, 4
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35 PMExploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 - Study Results - ClinicalTrials.govPage 2 of 21https://clinicaltrials.gov/ct2/show/results/NCT04632706
Recruitment Status
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: CompletedFirst Posted
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: November 17, 2020Results First Posted
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: December 27, 2021Last Update Posted
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: December 27, 2021
Study DetailsTabular ViewStudy Results
DisclaimerHow to Read a Study Record
Sponsor:
MedinCell S.A
Information provided by (Responsible Party):
MedinCell S.A
Study Type
Interventional
Study Design
Allocation: Randomized; Intervention Model: Sequential Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Other
Condition
Covid19
Interventions
Drug: IvermectinDrug: Placebo
Enrollment
24
Participant Flow
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Go to
1/10/22, 4
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35 PMExploratory Ph I Trial of the Active IMP in Healthy Volunteers in Relation to COVID-19 - Study Results - ClinicalTrials.govPage 3 of 21https://clinicaltrials.gov/ct2/show/results/NCT04632706
Recruitment Details Pre-assignment Details Arm/Group Title50mcg/kg (Oral)75mcg/kg (Oral)100mcg/kg (Oral)Matching Placebo (Oral) Arm/GroupDescriptionIvermectin loading doseof 200 mcg/kg followedby daily doses of50mcg/kg from D2 toD28Ivermectin loading doseof 200 mcg/kg followedby daily doses of75mcg/kg from D2 toD28Ivermectin loading doseof 200 mcg/kg followedby daily doses of100mcg/kg from D2 toD28Placebo tabletsmatching the ActiveInvestigative MedicinalProduct (IMP)Period Title:
Overall Study
Started6666Completed6656Not Completed0010
Baseline Characteristics
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Arm/Group Title50mcg/kg (Oral)75mcg/kg (Oral)100mcg/kg (Oral)Matching Placebo(Oral)Total Arm/GroupDescriptionIvermectin loadingdose of 200mcg/kg followedby daily doses of50mcg/kg from D2Ivermectin loadingdose of 200mcg/kg followedby daily doses of75mcg/kg from D2Ivermectin loadingdose of 200mcg/kg followedby daily doses of100mcg/kg fromPlacebo tabletsmatching the Active IMPTotal of allreporting groupsGo to