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 moderate 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 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with treatment-related adverse events | 30 days |
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. |
| Degree of supplemental oxygen | 30 days | Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation) |
| Peripheral Oxygen Saturation (SpO2) | 30 days | Peripheral oxygen saturation measured by pulse oximetry |
Countries
United States
Outcome results
None listed