SPI-1005 Treatment in Severe COVID-19 Patients
NCT04483973 · Status: ENROLLING_BY_INVITATION · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2023-10-03
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.
Conditions
- Covid19
- Coronavirus
- Coronavirus Infection
- Corona Virus Infection
Interventions
- DRUG
-
Ebselen
Glutathione peroxidase mimetic
- DRUG
-
Matching placebo containing excipients
Sponsors & Collaborators
-
Sound Pharmaceuticals, Incorporated
lead INDUSTRY
Principal Investigators
-
Miriam Treggiari, MD · Yale University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-08-27
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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