USE OF REPOURPOSED DRUGS LOSARTAN AND IVERMECTIN IN PATIENTS WITH CANCER FOR PREVENTION OF COVID-19 SERIOUS EVENTS DURING PANDEMIC. A randomized, double-blind, placebo-controlled phase II study.

Main Article Content

Pedro Exman, MD Renata Colombo Bonadio, MD Vanessa Petry Helena Bragaia, MD Camila Motta Venchiarutti Moniz, MD Ph Gabriel Watarai, MD Elaine Uchima Uehara Edson Abdala, MD PhD Paulo Marcelo Gehm Hoff, MD PhD Maria Del Pilar Estevez-Diz, MD PhD

Abstract

Introduction: Cancer patients are at higher risk of COVID-19 severe complications and also demonstrated a lower antibodies conversion after vaccination. Therefore, therapeutic approaches after COVID-19 infection are needed in this population. Repurposing drugs has emerged as an appealing strategy during pandemic, and drugs such as angiotensin 2 antagonists and ivermectin may have a role against COVID-19.


Objective: This trial evaluated losartan plus ivermectin aimed at decreasing the incidence of severe outcomes due to coronavirus infection among cancer patients.


Methods: This was a randomized, double-blind, and placebo-controlled phase II study. Cancer patients with recent diagnosis of mild to moderate COVID-19 were randomized to receive 50 mg of losartan for 15 days plus a single dose of 12 mg of ivermectin or placebo. The primary endpoint was the incidence of severe complications, defined as a need for admission to the intensive care unit (ICU), need for mechanical ventilation (MV), or death. Secondary endpoints were safety and adherence.


Results: Thirty-five patients were randomized to intervention arm and 34 to placebo arm. Seven (20%) patients in the losartan + ivermectin arm experienced severe outcomes versus 8 (23.5%) patients in the placebo arm (p = 1.00). No difference was observed in the need for intensive care unit (17.1% versus 17.6%; p = 1.00) or in the need for mechanical ventilation (17.1% versus 11.8%; p = 0.73). Four patients died in the losartan + ivermectin arm, while 3 in the placebo arm (11.4% versus 8.8%; p = 1.00). Severe adverse events and adherence were similar between groups.


Conclusions and Relevance: The combination of losartan and ivermectin did not improve severe COVID-19 outcomes among cancer patients. This is the first study registered on ClinicalTrials.gov that evaluates active treatment for COVID-19 exclusively for cancer patients. and more studies should be performed for a more aggressive approach in this high-risk population.

Keywords: COVID-19, cancer, losartan, ivermectin, repurposing drugs

Article Details

How to Cite
EXMAN, Pedro et al. USE OF REPOURPOSED DRUGS LOSARTAN AND IVERMECTIN IN PATIENTS WITH CANCER FOR PREVENTION OF COVID-19 SERIOUS EVENTS DURING PANDEMIC. A randomized, double-blind, placebo-controlled phase II study.. Medical Research Archives, [S.l.], v. 12, n. 4, apr. 2024. ISSN 2375-1924. Available at: <https://esmed.org/MRA/mra/article/view/5281>. Date accessed: 27 may 2024. doi: https://doi.org/10.18103/mra.v12i4.5281.
Section
Research Articles

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