SPI-1005 Treatment in Severe COVID-19 Patients

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

  • Covid19
  • Coronavirus
  • Coronavirus Infection
  • Corona Virus Infection

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