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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
SPI-1005 400 mg BID 		Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
  • Drug: Ebselen
    Glutathione peroxidase mimetic
    Other names:
    • SPI-1005
Experimental
SPI-1005 800 mg BID 		Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up
  • Drug: Ebselen
    Glutathione peroxidase mimetic
    Other names:
    • SPI-1005
Placebo Comparator
Placebo 		Oral administration of matching placebo BID for 14 days, with 30-day follow-up
  • Drug: Placebo
    Matching placebo containing excipients

Recruiting Locations

More Details

NCT ID
NCT04483973
Status
Enrolling by invitation
Sponsor
Sound Pharmaceuticals, Incorporated

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.