At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 25 enrolled / 25 target
Drug / intervention
Ebselen +1 moredrug
Likely dose
400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Ebselen and Placebo for Covid19 and 3 related conditions. Completed, enrolled 25 participants across 7 sites.
Signals
Enrollment appears stalled
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCovid19, Coronavirus, Coronavirus Infection, Corona Virus Infection
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedJul 2020
Enrollment StartAug 2021
Primary CompletionMay 2023
Study CompletionJun 2023
TodayJul 2026
First PostedJul 23, 2020
Enrollment StartAug 27, 2021
Primary CompletionMay 5, 2023
Study CompletionJun 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 5.9 years ago
Arms & Interventions
Placeboplacebo_comparator
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Drug: Placebo
SPI-1005 400 mg BIDactive_comparator
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Drug: Ebselen
Interventions
Ebselendrug
Glutathione peroxidase mimetic
Placebodrug
Matching placebo containing excipients