The study is a randomized, double-blind, placebo-controlled, dose escalation, multi-center clinical trial (RCT) of SPI-1005 in adult subjects with positive PCR test for novel SARS-CoV-2 (nCoV2) and severe symptoms of COVID-19 disease.
Drug: Ebselen
Glutathione peroxidase mimetic
Other Name: SPI-1005
Drug: Placebo
Matching placebo containing excipients
Inclusion Criteria:
- Adults ≥18 years of age
- Positive nCoV2 PCR test by nasopharyngeal, oral, saliva, or respiratory sample
- Clinical signs, symptoms, and respiratory status consistent with severe COVID-19
- Score of 5-7 on the WHO Ordinal Scale
- Onset of severe COVID-19 symptoms ≤7 days of study enrollment
- Subject is in-patient at time of randomization to study treatment
- Subject or legally authorized representative is willing and able to provide informed
consent, and agrees for subject to comply with planned study procedures including
reproductive requirements
Exclusion Criteria:
- Female patients who are pregnant or breastfeeding.
- Participation in another interventional investigational drug or device study
concurrently or within 30 days prior to study consent.
- Patients with impaired hepatic or renal function.
- Subject has any other illness or condition that, in the opinion of the investigator,
would prohibit the subject from participating.
Yale University
New Haven, Connecticut, United States
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Washington University in St. Louis
Saint Louis, Missouri, United States
Duke University
Durham, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
University of Texas Southwestern
Dallas, Texas, United States
Miriam Treggiari, MD, Principal Investigator
Yale University