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
Brief Summary

The primary objective of this study is to assess the efficacy of early administration ofivermectin for three consecutive days to prevent SARS-CoV-2 hospitalisation in adultsolder than 50 years of age. Secondary objectives include assessing the efficacy of anearly administration of ivermectin for three consecutive days to prevent SARS-CoV-2disease progression in adults older than 50 years of age and evaluating the safety andtolerability 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withdrawn from the trial unless they have a positive rapid antigen test or COVID-19 PCR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.

Terminated
COVID-19
SARS-CoV-2

Drug: Ivermectin

Round and white tablets
Other Name: Ivermectin 9 mg and 18 mg

Drug: Placebo

Round and white tablets

Eligibility Criteria

Inclusion Criteria:

1. Male or female adult > 50 years of age

2. 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

3. Onset of COVID-19 symptoms < 120 hours (5 days) prior to screening

4. Written informed consent

5. 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.

6. Negative result for urine pregnancy test (women of childbearing potential only)

Exclusion Criteria:

1. Intake of Ivermectin within 30 days before screening

2. Routine intake of antivirals, including antiretroviral treatment

3. Allergy, hypersensitivity or contraindication to Ivermectin, metabolites or
excipients

4. Subjects with symptoms of disease severity (dyspnoea, SpO2 ≤ 94%)

5. Subjects requiring hospitalisation for any reason.

6. Epidemiological risk or suspicion of being infected by Loa loa or other filariases

7. 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

8. Weight < 50 kg

9. Pregnancy or lactation

10. Inability to take oral medications

11. At least one of the following acute/chronic disease or deficiency:

1. History of bone marrow transplant or haematopoietic systems diseases

2. 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

3. 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)

4. Ophthalmological or recent/ongoing neurological diseases

12. Active cardiac disease or a history of cardiac dysfunction including any of the
following:

1. History of angina pectoris, symptomatic pericarditis, or myocardial infarction
within 12 months prior to screening

2. History of congestive heart failure (New York Heart Association functional
classification III-IV)

13. Concomitant use of barbiturates, sodium oxybate, valproic acid or warfarin

14. Laboratory abnormalities relevant for the trial, including but not limited to:
neutropenia < 500/mm3, thrombocytopenia < 100,000/mm3

15. 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

16. 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

17. Persons committed to an institution by virtue of an order issued either by the
judicial or other authorities

Eligibility Gender
All
Eligibility Age
Minimum: 50 Years ~ Maximum: N/A
Countries
Spain
Locations

Hospital de Poniente
El Ejido 2518494, Almeria, Spain

Hospital Universitari Germans Trias i Pujol
Badalona 3129028, Barcelona, Spain

Hospital General de Granollers
Granollers 3121145, Barcelona, Spain

Hospital San Pedro
Logroño 3118150, La Rioja 3336897, Spain

HM Montepríncipe
Boadilla del Monte 3127958, Madrid 3117732, Spain

HM Puerta del Sur
Móstoles 3116025, Madrid 3117732, Spain

HM Torrelodones
Torrelodones 3107765, Madrid 3117732, Spain

Clínica Universidad de Navarra
Pamplona 3114472, Navarre 3115609, Spain

Complejo Hospitalario Universitario A Coruña-CHUAC
A Coruña 3119841, Spain

Centro de Atención Primaria Les Corts
Barcelona 3128760, Spain

Hospital Clínic de Barcelona
Barcelona 3128760, Spain

Hospital de la Santa Creu i Sant Pau
Barcelona 3128760, Spain

Hospital Universitario de la Princesa
Madrid 3117735, Spain

Clínica Universidad de Navarra - Madrid
Madrid 3117735, Spain

Hospital Clínico San Carlos
Madrid 3117735, Spain

HM Sanchinarro
Madrid 3117735, Spain

Complejo Hospitalario de Navarra
Pamplona 3114472, Spain

Complejo Asistencial Universitario de Salamanca
Salamanca 3111108, Spain

Hospital Universitario Virgen de la Macarena
Seville 2510911, Spain

Hospital Universitari de Tarragona Joan XXIII
Tarragona 3108288, Spain

Not Provided

NCT Number
Keywords
Ivermectin
MeSH Terms
COVID-19
Ivermectin