A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Severe COVID-19 Patients

Sound Pharmaceuticals, Incorporated7 sites in 1 country60 target enrollmentAugust 27, 2021

ConditionsCovid19 Coronavirus Coronavirus Infection Corona Virus Infection

InterventionsPlacebo Ebselen

DrugsEbselen Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Covid19
Sponsor: Sound Pharmaceuticals, Incorporated
Enrollment: 60
Locations: 7
Primary Endpoint: Number of participants with treatment-related adverse events
Status: Enrolling by Invitation
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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 severe symptoms of COVID-19 disease.

Registry

clinicaltrials.gov

Start Date

August 27, 2021

End Date

December 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sound Pharmaceuticals, Incorporated

Responsible Party

Sponsor

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.