NCT04407507

Brief Summary

This study aims to evaluate the efficacy, safety and tolerability of Ivermectin in patients with mild SARS-CoV-2 infection, in the rate of progression to severe 2019 novel coronavirus disease (COVID-19). The primary efficacy endpoint is the proportion of participants with a disease control status defined as no progression of severe disease Hypothesis (H0): There is no difference between group A (ivermectin + paracetamol) and group B (ivermectin + paracetamol) in terms of the primary endpoint on day 14.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P25-P50 for phase_2 covid19

Timeline
Completed

Started Jul 2020

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 27, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 29, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 21, 2021

Completed
Last Updated

May 21, 2021

Status Verified

May 1, 2021

Enrollment Period

7 months

First QC Date

May 27, 2020

Results QC Date

May 10, 2021

Last Update Submit

May 19, 2021

Conditions

COVID-19

Keywords

Ivermectin

Outcome Measures

Primary Outcomes (1)

  • Participants With a Disease Control Status Defined as no Disease Progression to Severe.

    The subject is considered to have progressed to severe illness when one or more of the following criteria are present: 1. Breathing difficulty (≥30 breaths per minute); 2. Resting oxygen saturation ≤93%; 3. Severe complications such as: respiratory failure, need for mechanical ventilation, septic shock, non-respiratory organic failure.

    14 days

Secondary Outcomes (2)

  • SARS-CoV-2 Viral Load, at 5 and 14 Days

    days 1, 5 and 14

  • Presence and Frequency of Symptoms Associated With the COVID-19 Disease

    14 days

Study Arms (2)

Ivermectin

EXPERIMENTAL

Ivermectin 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days

Drug: Ivermectin

Placebo

PLACEBO COMPARATOR

Ivermectin placebo 12 mg / day for 3 days, in combination with paracetamol therapy (500 mg QID) for 14 days

Drug: Placebo

Interventions

IvermectinDRUG

ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days

Ivermectin
PlaceboDRUG

Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days

Placebo

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of acute severe respiratory syndrome due to SARS-CoV-12 coronavirus infection defined by RT-PCR.
  • Asymptomatic, or with mild symptoms who are taking outpatient treatment of the disease.
  • Signed Informed Consent.

You may not qualify if:

  • Patients with severe disease COVID-19.
  • Positive to proof of infection by some other virus such as influenza H1N1, SARS, etc.
  • Recurrent urinary tract infections.
  • Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST)\> 5 times above its normal limits.
  • Pregnant or lactating patients
  • Patients receiving antihypertensive medication verapamil, the immunosuppressant cyclosporin A and / or the antipsychotic trifluoperazine.
  • Patients with a known allergy or hypersensitivity to dewormers.
  • Patients who are using an antioxidant supplement.
  • Patients with a history of filariasis, strongyloidiasis, scabies, river blindness, or any parasitic disease in the last twelve months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Investigacion Biomédica para el Desarrollo de Fármacos S.A. de C.V.

Zapopan, Jalisco, Mexico

Location

Related Publications (6)

  • Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.

    PMID: 32251768RESULT

  • Chaccour CJ, Kobylinski KC, Bassat Q, Bousema T, Drakeley C, Alonso P, Foy BD. Ivermectin to reduce malaria transmission: a research agenda for a promising new tool for elimination. Malar J. 2013 May 7;12:153. doi: 10.1186/1475-2875-12-153.

    PMID: 23647969RESULT

  • Smit MR, Ochomo E, Aljayyoussi G, Kwambai T, Abong'o B, Bayoh N, Gimnig J, Samuels A, Desai M, Phillips-Howard PA, Kariuki S, Wang D, Ward S, Ter Kuile FO. Efficacy and Safety of High-Dose Ivermectin for Reducing Malaria Transmission (IVERMAL): Protocol for a Double-Blind, Randomized, Placebo-Controlled, Dose-Finding Trial in Western Kenya. JMIR Res Protoc. 2016 Nov 17;5(4):e213. doi: 10.2196/resprot.6617.

    PMID: 27856406RESULT

  • Xie M, Chen Q. Insight into 2019 novel coronavirus - An updated interim review and lessons from SARS-CoV and MERS-CoV. Int J Infect Dis. 2020 May;94:119-124. doi: 10.1016/j.ijid.2020.03.071. Epub 2020 Apr 1.

    PMID: 32247050RESULT

  • Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3.

    PMID: 32135219RESULT

  • de la Rocha C, Cid-Lopez MA, Venegas-Lopez BI, Gomez-Mendez SC, Sanchez-Ortiz A, Perez-Rios AM, Llamas-Velazquez RA, Meza-Acuna AI, Vargas-Iniguez B, Rosales-Galvan D, Tavares-Valdez A, Luna-Gudino N, Hernandez-Puente CV, Milenkovic J, Iglesias-Palomares C, Mendez-Del Villar M, Gutierrez-Dieck GA, Valderrabano-Roldan CG, Mercado-Cerda J, Robles-Bojorquez JG, Mercado-Sesma AR. Ivermectin compared with placebo in the clinical course in Mexican patients with asymptomatic and mild COVID-19: a randomized clinical trial. BMC Infect Dis. 2022 Dec 8;22(1):917. doi: 10.1186/s12879-022-07890-6.

    PMID: 36482326DERIVED

Related Links

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

Results Point of Contact

Title
Carmen de la Rocha
Organization
Investigacion Biomedica para el Desarrollo de Fármacos S.A. de C.V
carmen.delarocha@investigacionbiomedica.com.mx
523320028697

Study Officials

  • Alma M Perez, MD

    Centro de Investigación Farmacéutica Especializada de Occidente S.C.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2020

First Posted

May 29, 2020

Study Start

July 1, 2020

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

May 21, 2021

Results First Posted

May 21, 2021

Record last verified: 2021-05

Locations

ME(1)