Status:
TERMINATED
Ivermectin to Prevent SARS-CoV-2 (COVID-19) Hospitalisation in Subjects Over 50
Lead Sponsor:
Insud Pharma
Conditions:
COVID-19
SARS-CoV-2
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 ag...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 18 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2021
Estimated Enrollment :
249 Patients enrolled
Trial Details
Trial ID
NCT05993143
Start Date
January 18 2021
End Date
July 21 2021
Last Update
August 15 2023
Active Locations (20)
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1
Hospital de Poniente
El Ejido, Almeria, Spain, 04700
2
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Hospital General de Granollers
Granollers, Barcelona, Spain, 08402
4
Hospital San Pedro
Logroño, La Rioja, Spain, 26006