Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients
Brief Summary

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 moderate symptoms of COVID-19 disease.

Enrolling by invitation
COVID19
Corona Virus Infection
Coronavirus
Coronavirus Infection

Drug: Ebselen

Glutathione peroxidase mimetic
Other Name: SPI-1005

Drug: Placebo

Matching placebo containing excipients

Eligibility Criteria

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 moderate COVID-19

- Score of 3-4 on the WHO Ordinal Scale

- Onset of moderate COVID-19 symptoms ≤3 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United States
Locations

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

Sound Pharmaceuticals, Incorporated
NCT Number
Keywords
ebselen
SPI-1005
Covid-19
Covid
SARS-CoV-2
Mpro
main protease
PLpro
papain-like protease
MeSH Terms
Infections
Communicable Diseases
COVID-19
Coronavirus Infections
Ebselen