This is a 2-part, multi-center, randomized, double-blind, placebo-controlled, phase 2 study designed to evaluate the safety, tolerability, and efficacy of oral varespladib, in addition to standard of care, in patients hospitalized with severe COVID-19 caused by SARS-CoV-2.
The goals of this study are to define a safe dose for the population and to assess the safety, tolerability, and efficacy of orally dosed varespladib to improve survival without respiratory failure in patients hospitalized with severe COVID-19 when given in addition to the institutional standard of care therapy.
The mortality rates of COVID-19 are strongly linked to acute respiratory distress syndrome (ARDS) which is correlated with elevations of sPLA2 and widespread loss of functioning lung tissue. Upregulation of sPLA2 has been shown to be involved in the dysregulated inflammatory cascade pathways (increased markers of immune activation, also known as cytokine release syndrome) and enzymatic degradation of lung surfactant linked to the development of ARDS.
It is believed that treatment with varespladib, a potent inhibitor of sPLA2, will prevent or mitigate progression of pulmonary dysfunction in COVID-19 patients by two mechanisms: suppression of sPLA2-induced inflammation and, uniquely, preservation of pulmonary surfactant by direct inhibition of the enzyme responsible for surfactant phospholipid degradation. Data from previous Phase 2 clinical trials of varespladib suggest it was capable of reducing mortality in severely septic patients with ARDS, particularly when treatment was initiated within 18 hours of identification of organ failure. The study will be conducted in two parts. Both parts will be randomized and double-blind.
You might qualify for this clinical trial if you meet the following criteria:
- Participant is hospitalized with severe COVID-19 illness, defined in accordance with the FDA Guidance for Industry – COVID-19: Developing Drugs and Biological Products for Treatment or Prevention (May 2020)
- Participant has a positive virologic nucleic acid amplification test (NAAT) indicating SARS-CoV-2 infection in a sample collected < 72 hours prior to randomization
- Participant is between the ages of 18 and 80 years at the time of enrollment
- Participant (or legally authorized representative) provides informed consent prior to initiation of any study procedures
- Participant agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 through day 28
- Participant has adequate hematologic status (in the absence of transfusion and growth factor support for at least 28 days)
Clinical Trial Investigator
Dr. Jose David Suarez, Principal Investigator