Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50

NCT05993143 | Terminated Phase 3

• 1 other identifier: IVER-303
• Study Type: interventional
• Target: 249
• Locations: 1 country
• Sites: 20

Brief Summary

The primary objective of this study is to assess the efficacy of early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adults older than 50 years of age. Secondary objectives include assessing the efficacy of an early administration of ivermectin for three consecutive days to prevent SARS-CoV-2 disease progression in adults older than 50 years of age and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.

Conditions

COVID-19; SARS-CoV-2

Keywords

ivermectin

Outcome Measures

Primary Outcomes (1)

• Hospitalisation due to SARS-CoV-2

  Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration.

  day 1 to day 28

Secondary Outcomes (2)

• Change in subjects' clinical status

  day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28

• Occurrence of any adverse event related to Ivermectin treatment

  day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28

Study Arms (2)

Ivermectin (test product)

EXPERIMENTAL

Ivermectin 9 mg and 18 mg immediate-released tablets to be taken orally once daily during 3 days at 600 µg/kg/day ± 120 µg/kg/day depending on their body weight.

Drug: Ivermectin

Placebo (reference product)

PLACEBO COMPARATOR

Placebo tablets to be taken orally once daily during 3 days.

Drug: Placebo

Interventions

Ivermectin DRUG

Round and white tablets

Also known as: Ivermectin 9 mg and 18 mg

Ivermectin (test product)

Placebo DRUG

Round and white tablets

Placebo (reference product)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adult \> 50 years of age
• SARS-CoV-2 infection diagnosed either through a rapid antigen-based test or an RNA based reverse-transcription polymerase chain reaction (RT-PCR) diagnostic test performed in nasopharyngeal sample
• Onset of COVID-19 symptoms \< 120 hours (5 days) prior to screening
• Written informed consent
• For females of childbearing potential only: They must declare that they did not intend to become pregnant in the last month prior to screening and they do not intend to become pregnant for one month following the last IP administration. For males who have partners of childbearing potential: Willing to use condoms until 3 months after last IP intake.
• Negative result for urine pregnancy test (women of childbearing potential only)

You may not qualify if:

• Intake of Ivermectin within 30 days before screening
• Routine intake of antivirals, including antiretroviral treatment
• Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or excipients
• Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)
• Subjects requiring hospitalisation for any reason.
• Epidemiological risk or suspicion of being infected by Loa loa or other filariases
• Previous enrolment in this trial or participation in any other drug investigational trial within the past 30 days (or five half-lives of IP whichever is longer) prior to screening
• Weight \< 50 kg
• Pregnancy or lactation
• Inability to take oral medications
• At least one of the following acute/chronic disease or deficiency:
• History of bone marrow transplant or haematopoietic systems diseases
• Moderate or severe liver disease (Child Pugh score ≥ B or ALT \[alanine transaminase\] or AST \[aspartate transaminase\] \> 3 times upper limit as determined at screening visit), severe cholestasis, cirrhosis or severe hepatic failure
• Transplanted patient under immunosuppressive treatment, disease that may need immunosuppressive treatments or other medical conditions that under the judgement of investigator would not benefit the patient to be included (including but not limited to psoriasis, G6PD (glucose-6-phosphate dehydrogenase) deficiency, porphyria, history of diverticulosis, seizure disorder, concurrent malignancy requiring chemotherapy, ongoing skin infection (e.g. pyodermitis) or evidence of current tuberculosis including latent untreated tuberculosis)
• Ophthalmological or recent/ongoing neurological diseases

Sponsors & Collaborators

• Insud Pharma: lead

Study Sites (20)

Hospital de Poniente

El Ejido, Almeria, 04700, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

Hospital San Pedro

Logroño, La Rioja, 26006, Spain

Location

HM Montepríncipe

Boadilla del Monte, Madrid, 28660, Spain

Location

HM Puerta del Sur

Móstoles, Madrid, 28938, Spain

Location

HM Torrelodones

Torrelodones, Madrid, 28250, Spain

Location

Clínica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Complejo Hospitalario Universitario A Coruña-CHUAC

A Coruña, 15006, Spain

Location

Centro de Atención Primaria Les Corts

Barcelona, 08028, Spain

Location

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Clínica Universidad de Navarra - Madrid

Madrid, 28027, Spain

Location

Hospital Clínico San Carlos

Madrid, 28040, Spain

Location

HM Sanchinarro

Madrid, 28050, Spain

Location

Complejo Hospitalario de Navarra

Pamplona, 31008, Spain

Location

Complejo Asistencial Universitario de Salamanca

Salamanca, 37007, Spain

Location

Hospital Universitario Virgen de la Macarena

Seville, 41009, Spain

Location

Hospital Universitari de Tarragona Joan XXIII

Tarragona, 43005, Spain

Location

MeSH Terms

Conditions

COVID-19

Interventions

Ivermectin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Test (Ivermectin) and reference (placebo) tablets will be identical in size, colour, taste and appearance. The packaging and labelling will not allow for any distinction between the test and reference drug.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: August 15, 2023
• Study Start: January 18, 2021
• Primary Completion: July 21, 2021
• Study Completion: July 21, 2021
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (20)