Ivermectin to prevent SARS-CoV-2 (COVID-19) hospitalisation in subjects over 50
- Conditions
- Coronavirus disease (COVID-19)MedDRA version: 23.1Level: PTClassification code 10084460Term: COVID-19 treatmentSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2020-005015-40-SK
- Lead Sponsor
- Chemo Research S.L.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 832
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 prior to screening (Visit 1.1)
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)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 208
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 624
1.Intake of Ivermectin within 30 days before screening (Visit 1.1)
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 investigational product [IP] whichever is longer) prior to screening (Visit 1.1)
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:
a.History of bone marrow transplant or haematopoietic systems diseases
b.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 1.2), severe cholestasis, cirrhosis or severe hepatic failure
c.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)
d.Ophthalmological or recent/ongoing neurological diseases
12.Active cardiac disease or a history of cardiac dysfunction including any of the following:
a.History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to screening
b.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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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 Objective: 1. To assess 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<br>2. To evaluate the safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age;Primary end point(s): Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration;Timepoint(s) of evaluation of this end point: Data recorded on day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28. Final evaluation on day 28.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Change in subjects’ clinical status on Day 28<br>2. The occurrence of any adverse event related to Ivermectin treatment;Timepoint(s) of evaluation of this end point: Data recorded on day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21, 28. Final evaluation on day 28.