COVID-19 Clinical Trial
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
Verified date | August 2023 |
Source | Insud Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 age. Secondary objectives include assessing the 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 and evaluating the safety and tolerability of ivermectin in SARS-CoV-2 infected adults older than 50 years of age.
Status | Terminated |
Enrollment | 249 |
Est. completion date | July 21, 2021 |
Est. primary completion date | July 21, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Complejo Hospitalario Universitario A Coruña-CHUAC | A Coruña | |
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
Spain | Centro de Atención Primaria Les Corts | Barcelona | |
Spain | Hospital Clínic de Barcelona | Barcelona | |
Spain | Hospital de la Santa Creu i Sant Pau | Barcelona | |
Spain | HM Montepríncipe | Boadilla del Monte | Madrid |
Spain | Hospital de Poniente | El Ejido | Almeria |
Spain | Hospital General de Granollers | Granollers | Barcelona |
Spain | Hospital San Pedro | Logroño | La Rioja |
Spain | Clínica Universidad de Navarra - Madrid | Madrid | |
Spain | HM Sanchinarro | Madrid | |
Spain | Hospital Clínico San Carlos | Madrid | |
Spain | Hospital Universitario de la Princesa | Madrid | |
Spain | HM Puerta del Sur | Móstoles | Madrid |
Spain | Clínica Universidad de Navarra | Pamplona | Navarra |
Spain | Complejo Hospitalario de Navarra | Pamplona | |
Spain | Complejo Asistencial Universitario de Salamanca | Salamanca | |
Spain | Hospital Universitario Virgen de la Macarena | Sevilla | |
Spain | Hospital Universitari de Tarragona Joan XXIII | Tarragona | |
Spain | HM Torrelodones | Torrelodones | Madrid |
Lead Sponsor | Collaborator |
---|---|
Insud Pharma |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalisation due to SARS-CoV-2 | Percentage of subjects requiring SARS-CoV-2 hospitalisation during 28 days after first IP administration. | day 1 to day 28 | |
Secondary | Change in subjects' clinical status | 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. | day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28 | |
Secondary | Occurrence of any adverse event related to Ivermectin treatment | Evaluation of safety and tolerability of Ivermectin in SARS CoV 2 infected adults older than 50 years of age | day 1, 2, 3, 4, 6, 8, 10, 12, 14, 21 and 28 |
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