NCT04405843

Brief Summary

Double blind, placebo controlled, randomized clinical trial to evaluate the efficacy of ivermectin in preventing progression of disease in adult patients with early stages of COVID-19

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
476

participants targeted

Target at P75+ for phase_2 covid19

Timeline
Completed

Started Jul 2020

Shorter than P25 for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

December 28, 2020

Status Verified

December 1, 2020

Enrollment Period

5 months

First QC Date

May 23, 2020

Last Update Submit

December 24, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

  • Time to event

    Time until resolution of symptoms

    21 days

Secondary Outcomes (13)

  • Clinical condition on day 2

    On day 2 (± 1 day) after randomization

  • Clinical condition on day 5

    On day 5 (± 1 day) after randomization

  • Clinical condition on day 8

    On day 8 (± 1 day) after randomization

  • Clinical condition on day 11

    On day 11 (± 1 day) after randomization

  • Clinical condition on day 15

    On day 15 (± 1 day) after randomization

  • +8 more secondary outcomes

Study Arms (2)

Ivermectin

EXPERIMENTAL

Ivermectin, 300 micrograms / kg, once daily for 5 days

Drug: Ivermectin Oral Product

Placebo

PLACEBO COMPARATOR

Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

Drug: Placebo

Interventions

Ivermectin Oral ProductDRUG

Ivermectin oral suspension, 6 mg/mL

Ivermectin
PlaceboDRUG

Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 18 years of age
  • Confirmed SARS-CoV-2 by RT-PCR or antigen detection in a Colombian NIH-approved laboratory
  • Beginning of symptoms in the past 7 days
  • Mild disease
  • Informed consent

You may not qualify if:

  • Preexisting liver disease
  • Hypersensitivity to ivermectin
  • Participants in other clinical trials for therapies against COVID-19
  • Severe pneumonia
  • Pregnant or breastfeeding women
  • Concomitant use of warfarin, erdafitinib or quinidine
  • Use of ivermectin in the 5 days prior to randomization
  • Inability to obtain a blood sample needed to assess liver transaminases
  • Elevation of transaminases \>1.5 times the normal level
  • Participant whose first contact with the study personnel occurs between days 5 and 7 and at that time manifests significant and progressive resolution of COVID-19 related signs and symptoms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro de Estudios en Infectología Pediátrica

Cali, Valle del Cauca Department, 12345, Colombia

Location

Related Publications (1)

  • Lopez-Medina E, Lopez P, Hurtado IC, Davalos DM, Ramirez O, Martinez E, Diazgranados JA, Onate JM, Chavarriaga H, Herrera S, Parra B, Libreros G, Jaramillo R, Avendano AC, Toro DF, Torres M, Lesmes MC, Rios CA, Caicedo I. Effect of Ivermectin on Time to Resolution of Symptoms Among Adults With Mild COVID-19: A Randomized Clinical Trial. JAMA. 2021 Apr 13;325(14):1426-1435. doi: 10.1001/jama.2021.3071.

    PMID: 33662102DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic Chemicals

Study Officials

  • Eduardo López-Medina, MD MSc

    Scientific Director of Centro de Estudios en Infectología Pediátrica --CEIP--

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2020

First Posted

May 28, 2020

Study Start

July 14, 2020

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

December 28, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CO(1)