Ivermectin Effect on SARS-CoV-2 Replication in Patients With COVID-19

• Status: Completed
• Trial end date: 2020-09-29
• Target enrollment: 0
• Participant gender: All

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 useful for the therapy. IVM safety profile and IVM wide spectrum enables to move forward with the investigation in patients infected by SARS-CoV-2 as a proof-of-concept of its possible use in the management of patients with COVID-19, given the current pandemic situation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorio Elea Phoenix S.A.
• Collaborators: Centro de Investigación Veterinaria Tandil CIVETAN; Hospital de Pediatría Prof Dr. Juan P. Garrahan; Universidad Nacional de Quilmes; Universidad Nacional de Salta
• Treatments: Ivermectin

Criteria

Inclusion Criteria:

1. Patients of both genders, aged between 18 and 69.

2. Patients infected by SARS-CoV-2 confirmed by PCR.

3. Hospitalized patients with symptoms onset 5 days before executing the Informed Consent.

4. No comorbidities affecting the patient´s prognosis, rendering them high risk patients.

5. Documented acceptance to participate by means of the execution of the Informed Consent.

6. 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 Criteria:

1. Allergy or hypersensitivity to ivermectin and/or its inactive ingredients.

2. Patients meeting COVID-19 severity criteria, with respiratory distress or requiring intensive care.

3. Using medications having potential activity against SARS-CoV-2 such as hydroxychloroquine, chloroquine, lopinavir, ritonavir, remdesivir, azithromycin in the last 3 months.

4. Use of immunodepressants (including systemic corticosteroids) in the last 30 days.

5. Known HIV infection with CD4 count <300 cell/µL.

6. Pregnant or lactating patients.

7. Patients with other acute infectious diseases.

8. Patients with medical conditions such as malabsorption syndromes affecting proper ivermectin absorption.

9. Patients with acute allergy conditions or with severe allergic reactions background.

10. Patients with autoimmune disease and/or decompensated chronic diseases.

11. 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.