Coronavirus disease (COVID-19) MedDRA version: 23.1 Level: PT Classification code 10084460 Term: COVID-19 treatment System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Product Name: Ivermectin 9 mg tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Ivermectin
CAS Number: 70288-86-7
Other descriptive name: IVERMECTIN
Concentration unit: mg milligram(s)
Concentr
Sponsors
Chemo Research S.L.
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range 624
Exclusion criteria
Exclusion criteria: 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in subjects’ clinical status on Day 28 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. | — |
Countries
Czechia, Italy, Slovakia, Spain
Contacts
Public ContactMedical Director
Chemo Research S.L.
Outcome results
None listed