COVID-19


Active/Enrolling:

ACTIV-4a

  • Principal Investigator: Nicole Iovine, MD, PhD
  • https://clinicaltrials.gov/ct2/show/NCT04505774
  • The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. The risk of thrombotic complications is increased, even when compared to other viral respiratory illnesses, such as influenza. There has been significant demonstrated risk of deep venous thrombosis, pulmonary embolism, and myocardial infarction associated with viral respiratory infections, including COVID-19. This study aims to investigate the safety and efficacy of antithrombotic and anticoagulant study drugs in adjunct to standard of care (SOC) anticoagulant treatment or SOC treatment alone.
  • Contact: Chris Duncan, 352-273-8891, Christopher.Duncan@medicine.ufl.edu

ACTIV-4d

  • Principal Investigator: Nicole Iovine, MD, PhD
  • https://clinicaltrials.gov/ct2/show/NCT04924660
  • Novel Experimental COVID-19 Therapies Affecting Host Response (NECTAR/ACTIV-4HT) is a study aiming to find effective strategies for inpatient management of patients with COVID-19. Therapeutic goals for patients hospitalized for COVID-19 include hastening recovery and preventing progression to critical illness, multiorgan failure, or death. Its objective is to determine whether or not modulating the host tissue response improves clinical outcomes among patients with COVID-19.
  • Contact: Chris Duncan, 352-273-8891, Christopher.Duncan@medicine.ufl.edu

ACTIV-5/BET

  • Principal Investigator: Nicole Iovine, MD, PhD
  • https://www.clinicaltrials.gov/ct2/show/NCT04583969 (BET-C); https://clinicaltrials.gov/ct2/show/NCT04988035 (BET-D)
  • The ACTIV-5/BET trials aim to evaluate the clinical efficacy of different investigational therapeutic medications or placebo, both in conjunction with the antiviral drug remdesivir, as a standard of care arm. At the University of Florida, patients were randomized to one of two investigational arms, B or C. Arm B (BET-B) includes the investigational monoclonal antibody, lenzilumab, in combination with remdesivir. Arm C (BET-C) tests Danicopan, a complement factor D inhibitor, in combination with remdesivr.
  • Contact: Chris Duncan, 352-273-8891, Christopher.Duncan@medicine.ufl.edu

Closed to Enrollment:

None at this time; please check back soon.

Pending:

ACTIV-2d

  • Principal Investigator: Gary Wang, MD, PhD
  • https://clinicaltrials.gov/ct2/show/NCT05305547
  • ACTIV-2d is a study that aims to evaluate the safety and efficacy of investigational treatments versus a placebo for the subpopulation of patients who were not expected to receive the standard of care antiviral treatment that was given to those who were critically ill (defined as monoclonal antibodies or outpatient intravenous remdesivir). The study aims to determine the effects of the investigational agent on all-cause hospitalizations or death in symptomatic patients with high risk of disease progression.
  • Contact: Steven Fowler, 352-294-5277, stevenfowler@ufl.edu

Completed:

ACTT

  • Principal Investigator: Nicole Iovine, MD, PhD
  • https://clinicaltrials.gov/ct2/show/NCT04280705 (ACTT-1); https://clinicaltrials.gov/ct2/show/NCT04401579 (ACTT-2); https://clinicaltrials.gov/ct2/show/NCT04492475 (ACTT-3); https://clinicaltrials.gov/ct2/show/NCT04640168 (ACTT-4)
  • The Adaptive COVID-19 Treatment Trial (ACTT) is a randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial conducted in approximately 100 sites globally. ACTT seeks to investigate different investigational therapeutic agents compared to a control arm. New arms can be introduced according to scientific and public health needs. Interim monitoring is done to allow early stopping for futility, efficacy, or safety; If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s).

ACTIV-2a

  • Principal Investigator: Gary Wang, MD, PhD
  • https://clinicaltrials.gov/ct2/show/study/NCT04518410
  • ACTIV-2a, also known as an Adaptive Platform Treatment Trial Outpatients with COVID-19 is an outpatient study used to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic, non-hospitalized adults with COVID-19. The trial is a randomized, blinded, placebo-controlled, adaptive platform that allows agents to be added and dropped during the course of the study for efficient testing of new agents. Infused agents enrollments are restricted to participants at higher risk to prevent progression to severe COVID-19. Non-infused agents include participants at both a “higher” or “lower” risk of progression to severe COVID-19.