search
Back to results

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

Primary Purpose

COVID-19, SARS-CoV-2

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Ivermectin
Placebo
Sponsored by
Insud Pharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring ivermectin

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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) Exclusion Criteria: 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 Active cardiac disease or a history of cardiac dysfunction including any of the following: History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening History of congestive heart failure (New York Heart Association functional classification III-IV) Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100,000/mm3 Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator Persons committed to an institution by virtue of an order issued either by the judicial or other authorities

Sites / Locations

  • Hospital de Poniente
  • Hospital Universitari Germans Trias i Pujol
  • Hospital General de Granollers
  • Hospital San Pedro
  • HM Montepríncipe
  • HM Puerta del Sur
  • HM Torrelodones
  • Clínica Universidad de Navarra
  • Complejo Hospitalario Universitario A Coruña-CHUAC
  • Centro de Atención Primaria Les Corts
  • Hospital Clínic de Barcelona
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario de la Princesa
  • Clínica Universidad de Navarra - Madrid
  • Hospital Clínico San Carlos
  • HM Sanchinarro
  • Complejo Hospitalario de Navarra
  • Complejo Asistencial Universitario de Salamanca
  • Hospital Universitario Virgen de la Macarena
  • Hospital Universitari de Tarragona Joan XXIII

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ivermectin (test product)

Placebo (reference product)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in subjects' clinical status
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.
Occurrence of any adverse event related to Ivermectin treatment
Evaluation of safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age

Full Information

First Posted
August 8, 2023
Last Updated
August 10, 2023
Sponsor
Insud Pharma
search

1. Study Identification

Unique Protocol Identification Number
NCT05993143
Brief Title
Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50
Official Title
A Multicentre, Phase III, Double-blind, Randomised, Parallel, Placebo-controlled Trial to Assess Efficacy and Safety of Early Administration of Ivermectin During 3 Consecutive Days to Prevent SARS CoV-2 (COVID-19) Hospitalisation in Adults Older Than 50 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Terminated
Why Stopped
Study was stopped because no statistically significant difference was observed in the interim analysis. With high vaccine rates in those over 50 and an expected low incidence, it would not be feasible to complete recruitment within a short period.
Study Start Date
January 18, 2021 (Actual)
Primary Completion Date
July 21, 2021 (Actual)
Study Completion Date
July 21, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insud Pharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
This is a randomised, double-blind, placebo-controlled, multicentre trial in parallel groups. During the screening/enrollment phase (Visit 1.1 to Visit 1.3) informed consent will be obtained and the screening procedures will be performed. A rapid antigen-based test will be offered to all patients who do not have a polymerase chain reaction (PCR) or a rapid antigen-based test result at screening (each of these tests may be considered a part of the standard procedure of the site). Eligible subjects will be randomised 1:1 to receive ivermectin or placebo. The subjects will be dispensed investigational product (IP), based on their body weight, and will take the first dose of IP at site. The subjects will receive portable pulse oximeters for peripheral capillary oxygen saturation (SpO2) monitoring at home. The treatment phase will last 3 days and include an on-site Visit 1.3 and phone call Visits 2 and 3 which will be performed on the following 2 days. PCR test or rapid antigen test results will be communicated to subjects as soon as available. Subjects with negative COVID-19 PCR test or rapid antigen test results will be withdrawn from the trial unless they have a positive rapid antigen test or COVID-19 PCR test result a few days later. The subjects will be followed up until Day 28. During the follow-up, the subjects will have phone call Visits 4 to 9 every other day, followed by Visit 10 after one week (Day 21). The subjects will be asked to measure oxygen saturation as well as body temperature during all phone call visits and report the respective results to the investigator. The on-site Visit 11 is the last visit (Day 28). The subjects will return IPs (including empty and partially empty containers) and pulse oximeters. In addition, the subjects will be provided with a contact number available 24/7 to contact the investigator if their condition worsens. In case of health condition worsening (dyspnoea, fever [body temperature ≥ 37.8°C] lasting for more than 6 days, SpO2 ≤ 95% or any other worsening criteria based on the investigator's judgement) confirmed during the phone call visit, the subjects will have an unscheduled visit at the site. The subjects will be hospitalised if they fulfill any of the following criteria: pneumonia confirmed by chest X-ray; SpO2 ≤ 94% or partial pressure of oxygen in blood (PO2) < 80 mmHg in gasometry; respiratory frequency > 20 rpm; fever (body temperature ≥ 37.8°C) for more than 6 days plus one of the following analytic parameters: C-reactive protein (CRP) > 5 mg/dL, ferritin > 500 ng/mL or D dimer > 700 ng/mL. If there is any other condition that requires hospitalisation as per investigator judgement, the condition has to be documented in detail in the subject's file including a description whether the hospitalisation was performed due to SARS-CoV-2 infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, SARS-CoV-2
Keywords
ivermectin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
249 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ivermectin (test product)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo (reference product)
Arm Type
Placebo Comparator
Arm Description
Placebo tablets to be taken orally once daily during 3 days.
Intervention Type
Drug
Intervention Name(s)
Ivermectin
Other Intervention Name(s)
Ivermectin 9 mg and 18 mg
Intervention Description
Round and white tablets
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Round and white tablets
Primary Outcome Measure Information:
Title
Hospitalisation due to SARS-CoV-2
Description
Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration.
Time Frame
day 1 to day 28
Secondary Outcome Measure Information:
Title
Change in subjects' clinical status
Description
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.
Time Frame
day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28
Title
Occurrence of any adverse event related to Ivermectin treatment
Description
Evaluation of safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age
Time Frame
day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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 Active cardiac disease or a history of cardiac dysfunction including any of the following: History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening History of congestive heart failure (New York Heart Association functional classification III-IV) Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin Laboratory abnormalities relevant for the trial, including but not limited to: neutropenia < 500/mm3, thrombocytopenia < 100,000/mm3 Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the subject because of participation in the study, affect the ability of the subject to participate in the study or impair interpretation of the study data Employees of the investigator or clinical trial site, with direct involvement in the proposed trial or other studies under the direction of that investigator or clinical trial site, as well as family members of the employees or the principal investigator Persons committed to an institution by virtue of an order issued either by the judicial or other authorities
Facility Information:
Facility Name
Hospital de Poniente
City
El Ejido
State/Province
Almeria
ZIP/Postal Code
04700
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General de Granollers
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08402
Country
Spain
Facility Name
Hospital San Pedro
City
Logroño
State/Province
La Rioja
ZIP/Postal Code
26006
Country
Spain
Facility Name
HM Montepríncipe
City
Boadilla del Monte
State/Province
Madrid
ZIP/Postal Code
28660
Country
Spain
Facility Name
HM Puerta del Sur
City
Móstoles
State/Province
Madrid
ZIP/Postal Code
28938
Country
Spain
Facility Name
HM Torrelodones
City
Torrelodones
State/Province
Madrid
ZIP/Postal Code
28250
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña-CHUAC
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Centro de Atención Primaria Les Corts
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Hospital Universitario de la Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Clínica Universidad de Navarra - Madrid
City
Madrid
ZIP/Postal Code
28027
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
HM Sanchinarro
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Complejo Hospitalario de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Asistencial Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Universitario Virgen de la Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Universitari de Tarragona Joan XXIII
City
Tarragona
ZIP/Postal Code
43005
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs