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ClinicalTrials.gov; 08/08/2023; TrialID: NCT05993143
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05993143
ABSTRACT
Condition:
COVID-19;SARS-CoV-2Intervention:
Drug: Ivermectin;Drug: PlaceboPrimary outcome:
Hospitalisation due to SARS-CoV-2Criteria:
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