Status:
COMPLETED
Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19
Lead Sponsor:
Laboratorio Elea Phoenix S.A.
Collaborating Sponsors:
Universidad Nacional de Salta
Centro de Investigación Veterinaria Tandil CIVETAN
Conditions:
COVID-19 Drug Treatment
Eligibility:
All Genders
18-69 years
Phase:
PHASE2
Brief Summary
In the context of COVID-19 pandemic, a report on ivermectin suppression of SARS-CoV-2 viral replication in cell cultures has been published, and the use of this medication seems to be potentially usef...
Detailed Description
Ivermectin (IVM) is a semisynthetic antiparasitic agent belonging to the avermectin group, drugs isolated from Streptomyces avermitilis. Ivermectin is widely used for humans and animals, with millions...
Eligibility Criteria
Inclusion
- Patients of both genders, aged between 18 and 69.
- Patients infected by SARS-CoV-2 confirmed by PCR.
- Hospitalized patients with symptoms onset 5 days before executing the Informed Consent.
- No comorbidities affecting the patient´s prognosis, rendering them high risk patients.
- Documented acceptance to participate by means of the execution of the Informed Consent.
- Female patients of childbearing age must have a negative pregnancy test and must use adequate contraceptive methods (for example, intrauterine devices, hormonal contraceptives, barrier methods, chastity or tubal ligation) during their participation in the study and for one month after the last medication dose in the case of those receiving ivermectin.
Exclusion
- Allergy or hypersensitivity to ivermectin and/or its inactive ingredients.
- Patients meeting COVID-19 severity criteria, with respiratory distress or requiring intensive care.
- Using medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin in the last 3 months.
- Use of immunodepressants (including systemic corticosteroids) in the last 30 days.
- Known HIV infection with CD4 count \<300 cell/µL.
- Pregnant or lactating patients.
- Patients with other acute infectious diseases.
- Patients with medical conditions such as malabsorption syndromes affecting proper ivermectin absorption.
- Patients with acute allergy conditions or with severe allergic reactions background.
- Patients with autoimmune disease and/or decompensated chronic diseases.
- Patients with uncontrolled, intercurrent diseases including renal impairment, hepatic impairment, symptomatic congestive heart failure, unstable chest angina, heart arrhythmia or psychiatric conditions that may limit adherence to CT requirements.
Key Trial Info
Start Date :
May 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 29 2020
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT04381884
Start Date
May 18 2020
End Date
September 29 2020
Last Update
October 5 2020
Active Locations (3)
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1
Hospital de Cuenca Alta
Cañuelas, Buenos Aires, Argentina
2
Centro de Educación Médica e Investigaciones Clínicas "Norberto Quirno" CEMIC
Buenos Aires, Buenos Aires F.D., Argentina
3
Hospital de Infecciosas Francisco Javier Muñiz
Buenos Aires, Argentina, C1282AEN