SPI-1005 Treatment in Moderate COVID-19 Patients

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Sound Pharmaceuticals, Incorporated
Study ID
NCT04484025
Phase
PHASE2
Status
Enrolling By Invitation

Conditions

  • Corona Virus Infection
  • Coronavirus
  • Coronavirus Infection
  • Covid19

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ebselen — DRUG
    Glutathione peroxidase mimetic
  • Placebo — DRUG
    Matching placebo containing excipients

Study Details

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.

Key Dates

Start date
Oct 12, 2021
Status verified
Oct 2023
Primary completion
Dec 31, 2023
Completion
Dec 31, 2023

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SPI-1005 400 mg BID
    Oral administration of SPI-1005 400 mg BID for 7 days, with 30-day follow-up
  • Experimental: SPI-1005 800 mg BID
    Oral administration of SPI-1005 800 mg BID for 7 days, with 30-day follow-up
  • Placebo Comparator: Placebo
    Oral administration of matching placebo BID for 7 days, with 30-day follow-up

Primary Outcome Measure

Number of participants with treatment-related adverse events [ Time Frame: 30 days ]

Locations (7)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510-
St. Luke's Cystic Fibrosis Center of IdahoBoiseIdaho83702-
Kansas University Medical CenterKansas CityKansas66160-
Washington University in St. LouisSt LouisMissouri63130-
Duke UniversityDurhamNorth Carolina27710-
Wake Forest UniversityWinston-SalemNorth Carolina27109-
University of Texas SouthwesternDallasTexas75390-

Find similar trials in New Haven, CT

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Yale University· New Haven, CTSt. Luke's Cystic Fibrosis Center of Idaho· Boise, IDKansas University Medical Center· Kansas City, KSWashington University in St. Louis· St Louis, MODuke University· Durham, NCWake Forest University· Winston-Salem, NC

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