Yet another major ivermectin clinical trial is just a couple weeks from initiation in Cali Colombia led by Dr. Eduardo Lopez sponsored by the Centro de Estudios en Infectogia Pediatrica—The Center for Clinical Research and Comprehensive Care of Infectious Diseases. TrialSite News was able to interview the investigator as he prepares for what will be an important clinical study assessing ivermectin in 400 adult patients with mild COVID-19: the study should start within two weeks or before the end of June 2020.
Ivermectin: The Wave
Since March, TrialSite News has been tracking the ivermectin wave in association with the COVID-19 pandemic. Starting with the initial pathbreaking lab research work accomplished by Monash University and the Peter Doherty Institute demonstrating that ivermectin literally zaps SARS-CoV-2 virus in a cell culture to the Broward Health Board approved, off-label observational study completed in Florida to the interview with a physican at Bangladesh Medical College who reported to TrialSite News in an interview that the results for a hospital approved, off-label of 60 COVID-19 patients study were “astounding.” Then there are the growing number of clinical trials from Argentina and Brazil to Iraq, Egypt and Bangladesh not to mention Johns Hopkins University and the University of Kentucky in the United States.
The Interview with Principal Investigator Dr. Lopez
TrialSite News was able to connect with Dr. Eduardo Lopez, an infectious disease and pediatric physician and epidemiologist. Serving as principal investigator at Cali, Colombia’s Centro de Estudios en Infectogia Pediatrica, Dr. Lopez reported that this site has broad experience in undertaking vaccine studies, general clinical trials as well as epidemiological studies there in Cali.
Dr. Lopez commented that Cali is in the Valle del Cauca state (called departments there) in Colombia. With 130 new COVID-19 cases in Cali alone, Colombia has a total of 45,212 cases with 1,488 deaths in a country of just under 50 million people. According to the U.S. Embassy in Colombia the country is experiencing widespread, ongoing transmission of COVID-19.
The trial will hopefully commence in just two weeks. Again the study received ethics committee approval and two weeks ago they submitted the application to the Colombian national regulatory authority called “INVIMA” to commence the ivermectin trial; INVIMA requested what Dr. Lopez termed “minor changes” prior to approval. That package was resubmitted just as of this writing so the study should proceed shortly given there were only minor changes.
Dr. Lopez continued that the study at his site in Cali is a randomized, placebo controlled, double-blind clinical trial studying the efficacy of ivermectin in adult patients with early stage COVID-19. The study has been designed to help the investigators determine whether ivermectin decreases or increases the time until deterioration with two or more points in an ordinal 7 point scale. The study team will also assess a handful of secondary outcome measures such as clinical condition based on ordinal scale at different time points, the proportion of patients that will require hospitalization, use of supplementary oxygen and required hospitalization is different than that of the placebo arm, for example. The team will also monitor for adverse events.
Planning to start within weeks, the Phase 2/3 study will run till the end of November, 2020.
The Research Site
Dr. Lopez is a Principal Investigator at Cali Colobmbia’s Centro de Estudios en Infectogia Pediatrica—translating to The Center for Clinical Research and Comprehensive Care of Infectious Diseases. This research site describes itself on professional social networking site LinkedIn as one that provides clinical research services and comprehensive care for those with infectious diseases all supported by a fully GcP compliant framework working under GcP. Their goal is to “reduce illness in the pediatric population while contributing to scientific knowledge, health policies, and social responsibility within the community.” TrialSite News estimates the site to employ between 10 to 20 health workers and professionals.
Note Dr. Lopez has been placed on “Top Doctors” in Colombia.
Call to Action: TrialSite News will update the TrialSite Network when Dr Lopez receives final approval from INVIMA. Sign up for the TrialSite News daily newsletter for updates.