Spanish Research Center Launches Ivermectin Clinical Trial Targeting Mild COVID-19 Patients

May 15, 2020 | Clinical Universidad de Navarra, COVID-19, ISGlobal, Ivermectin, Leading Sites, News, Popular Posts, SARS-CoV-2, Site Success, Site Watch, Spain

Spanish Research Center & Provider Launch Ivermectin Clinical Trial Targeting Mild COVID-19 Patients

Clinical Universidad de Navarra and the Barcelona Institute for Global Health (ISGlobal), a center supported by “la Caixa” Foundation, have launched a clinical trial to investigate the efficacy of ivermectin against COVID-19. The study team will combine ivermectin with Idilfarma to determine whether administration of ivermectin is associated with a shorter clearance time.

Background

Ivermectin was recently evidenced to inhibit the replication of SARS-CoV-2 in vitro at very high doses (Monash University, Australia), but this effect is now being tested in a number of studies from Johns Hopkins University to University of Kentucky in the United States, Tanta University in Egypt, as well as centers in Argentina and Iraq.  

The Study

Titled the SARS-CoV-2 Ivermectin Navarra ISGlobal Trial (SAINT), the Spanish study’s investigators will probe with a randomized trial with 24 participants with mild cases of COVID-19 and no risk factors receiving a single oral dose of ivermectin or placebo less than 48 hours after the onset of the symptoms.

In the study, the newly diagnosed patients don’t require hospitalization, so follow-up is carried out in their homes during their period of self-isolation, reports the Barcelona Institute for Global Health.

Carlos Chaccour, a specialist affiliated with Clinica Universidad de Navarra and ISGlobal and principal investigation for the new study, reports, “Ivermectin has shown to have an antiviral effect against other single-chain RNA viruses, including dengue and yellow fever, and it has successfully inhibited the replication of those viruses in vitro.” He continued, “We are also interested in assessing the drug’s immunomodulatory role because one of the major problems with the SARS-CoV-2 virus is the disordered immune response it causes.”

The investigator Chaccour continued that they “will give patients a single dose when they come to the clinic for a diagnostic test.” They will then do follow up appointments after a month-long period of home-based follow-up; at that time in the study, the investigational team will take five nasal swabs and monitor the symptoms. They will be probing whether the ivermectin helps clear the infection in a more efficacious and expedited manner.

The Sponsors

Clinical Universidad de Navarra is a hospital in Spain that has been ranked in the World’s Best Hospitals. Barcelona Institute for Global Health is the result of an alliance between “la Caixa”, academic institutions, and government bodies to contribute to the efforts undertaken by the international community to address the challenges to good health. Also known as ISGlobal—a consolidation hub of excellence in research—the center has grown out of work started in the world of health care by the Hospital Clinic and the Parc de Salut Mar and in the academic sphere by the University of Barcelona.

Study Funder

The SAINT study is being funded by Clinical Universidad de Navarra ISGlobal.

Lead Research/Investigator

Carlos Chaccour, MD

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Source: ISGlobal

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