COVID-19

Born out of the COVID-19 pandemic, the Miami COVID Cohort: Developing the Foundation for a Comprehensive Approach to COVID-19 is a study of viral persistence, immunological responses, and psychosocial factors of those affected by COVID-19 within Miami. Led by Dr. Maria Alcaide, MD, research gathered will advance data on COVID-19 for a targeted approach to testing and treatment. This study concluded in 2021.

The University of Miami’s Infectious Diseases Division is proud to be one of the NIH Coronavirus Prevention Network (CoVPN) sites for the Phase 3 clinical trial of the Moderna COVID-19 vaccine, which received emergency approval from the FDA on December 18, 2020. Led by Dr. Doblecki-Lewis, MD, this trial determined the safety and efficacy of the novel coronavirus vaccine using mRNA, an emerging platform with demonstrated potential in vaccines. mRNA allows vaccines to be designed without using the virus itself. The two dose, 95.6% effective vaccine is being rolled out to states as part of a federal initiative to vaccinate U.S. citizens against COVID-19. The trial has completed enrollment and is continuing follow-up of enrolled participants to determine the durability of protection.

The vaccine being tested in this study is called mRNA-1273.  The study team is testing if the vaccine can help the immune system produce effective antibodies against the SARS-CoV-2 virus so that, in case of infection, the virus does not cause illness. The vaccine cannot cause infection or make someone sick with COVID-19.

The Infectious Diseases Division participates in multiple studies to assess the safety and efficacy of leading COVID-19 therapeutic treatments. The following is a list of ongoing trials by divisional faculty. 

1. CONTAIN is a multi-site collaborative study focused on the use of convalescent plasma to limit coronavirus associated complications in a randomized blinded Phase 2 study. Funded by the NCATS, the University of Miami site location is led by Dr. Dushyantha Jayaweera. With 200 enrolled subjects in Miami, this study will advance clinical treatment of COVID-19 in hospitalized patients.
   
   
2. Led by Dr. Shweta Anjan, the Human Coronavirus Immune Plasma study is a randomized, double-blind, controlled Phase 2 study compares the efficacy and safety of Human Coronavirus Immune Plasma (HCIP) versus Control Plasma (SARS-CoV-2 non-immune) among outpatients with symptomatic COVID-19. Sponsored by the US ARMY Medical Research and Material Command in partnership with Johns Hopkins University and the NIH, the study will help clinicians understand how best to utilize convalescent plasma in the recovery of COVID-19 patients.
   
   
3. The Miami COVID Infectious Disease Retrospective study targets the clinical characteristics of SARS-CoV-2 infection and responses to therapies and is led by Dr. Stephen Morris.
   
   
4. Led by Dr. Lilian Abbo, MIS-A versus severe COVID-19 is a sentinel surveillance and retrospective cohort analysis investigating Multisystem Inflammatory Syndrome in adults resulting from severe COVID-19.
   
   
5. Funded by the NIH, Dr. Mark Sharkey, Co-Investigator, is developing and implementing a South Florida Miami RADx-rad SARS-CoV-2 wastewater-based surveillance infrastructure. This research initiative monitors the prominence and spread of COVID-19 in the Miami-Dade population.
   
6. Therapeutics for Inpatients with COVID-19 (TICO): A Multicenter, adaptive, Randomized, Blinded Controlled Trial of the safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19
   Primary Investigator: Dr. Paola Lichtenberger
   
   
7. PREVENT-19 TRIAL: Pre-fusion Protein Subunit Vaccine Efficacy Novavax Trial/ COVID-19. 
   Co-Investigator: Dr. Paola Lichtenberger 
   
   
8. A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Varespladib in Patients Hospitalized with Severe COVID-19 Caused by SARS-CoV-2 (STAIRS): Small molecule Targeting Acute Inflammatory and Respiratory Symptoms in SARS-CoV-2. 
   Primary Investigator: Dr. Paola Lichtenberger