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SPI-1005 Treatment in Severe COVID-19 Patients

CompletedPhase 2

Sponsor: Sound Pharmaceuticals, Incorporated

Conditions: Covid19, Coronavirus, Coronavirus Infection, Corona Virus Infection

Interventions: Ebselen, Placebo

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 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.

Locations (7)

New Haven, Connecticut, United States
Boise, Idaho, United States
Kansas City, Kansas, United States
St Louis, Missouri, United States
Durham, North Carolina, United States
Winston-Salem, North Carolina, United States
Dallas, Texas, United States