Coronavirus, Coronavirus Infection, Corona Virus Infection, Covid19
Conditions
Keywords
ebselen, SPI-1005, COVID-19, Covid, SARS-COV-2, Mpro, main protease, PLpro, papain-like protease
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 severe symptoms of COVID-19 disease.
Interventions
DRUGEbselen
Glutathione peroxidase mimetic
DRUGPlacebo
Matching placebo containing excipients
Sponsors
Sound Pharmaceuticals, Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-related Adverse Events | 30 days | Number of participants with adverse events, categorized by Common Terminology Criteria for Adverse Events (CTCAE) grading for severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| WHO Ordinal Scale | 30 days | Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMiriam Treggiari, MD
Yale University
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 57.7 years STANDARD_DEVIATION 16.7 |
| COVID-19 Vaccination No | 5 Participants |
| COVID-19 Vaccination Yes | 4 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 13 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 5 Participants |
| WHO Ordinal Scale | 5.44 units on a scale STANDARD_DEVIATION 0.65 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 9 | 4 / 16 |
| other Total, other adverse events | 1 / 9 | 8 / 16 |
| serious Total, serious adverse events | 3 / 9 | 5 / 16 |
Outcome results
None listed