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Brief Title: Early Treatment With Ivermectin and LosarTAN for Cancer Patients With COVID-19 Infection
Official Title: Randomized, Doubled-blind Phase II Trial Evaluating the Use of Ivermectin Plus Losartan for Prophylaxis of Severe Events in Cancer Patients With Recent Diagnosis of COVID-19
Study ID: NCT04447235
Brief Summary: Ivermectin plus losartan as prophilaxy to severe events in patients with cancer with recent diagnosis of COVID-19
Detailed Description: This is a randomized, doubled-blind and placebo-controlled phase II study that will evaluate the efficacy of the early use of ivermectin plus losartan in cancer patients who present with recent diagnosis of COVID-19. The trial will enroll 176 patients with previous diagnosis of active cancer (88 in each arm) and the aim of the study is to assess the efficacy of these drugs combination to decrease the incidence of COVID-19 severe complications. Patients will receive single dose ivermectin of 12mg after the confirmed diagnosis of COVID-19, followed by 15 days of losartan. We believe that the association of anti-viral activity of the ivermectin plus the extracellular blockade of the receptor used by the virus will decrease the overall viremia and subsequently improve clinical outcomes.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Instituto do Cancer do Estado de Sao Paulo, SAo Paulo, , Brazil
Name: Pedro Exman, MD
Affiliation: Instituto do Cancer do Estado de São Paulo
Role: PRINCIPAL_INVESTIGATOR
Name: Maria del Pilar Diz, MD, PhD
Affiliation: Instituto do Cancer do Estado de São Paulo
Role: STUDY_DIRECTOR