COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04381884

Ricardo Valentini, MD

Alejandro Krolewiecki, alekrol@hotmail.com (PI email not reported)

2020-05-11

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: 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.

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.

2

Laboratorio Elea Phoenix S.A.

18

69

Argentina

Moderate disease at enrollment

3: Moderate disease at enrollment

45

Reduction in SARS-CoV-2 viral load

None

Phase 2

[{"arm_notes": "", "treatment_id": 693, "treatment_name": "Ivermectin", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]