SPI-1005 Treatment in Severe COVID-19 Patients

Phase 2

• Conditions: Coronavirus; Corona Virus Infection; Covid19; Coronavirus Infection
• Interventions: Drug: Placebo; Drug: Ebselen

• Registration Number: NCT04483973
• Lead Sponsor: Sound Pharmaceuticals, Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-13
• Study First Submitted QC: 2020-07-21
• Study First Posted: 2020-07-23
• Study Start: 2021-08-27
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-02
• Last Update Posted: 2023-10-03
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Oral administration of matching placebo BID for 14 days, with 30-day follow-up
SPI-1005 400 mg BID	Ebselen	Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
SPI-1005 800 mg BID	Ebselen	Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up

Primary Outcome Measures

Name	Time	Method
Number of participants with treatment-related adverse events	30 days

Secondary Outcome Measures

Name	Time	Method
Degree of supplemental oxygen	30 days	Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)
Peripheral Oxygen Saturation (SpO2)	30 days	Peripheral oxygen saturation measured by pulse oximetry
WHO Ordinal Scale	30 days	Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.

Trial Locations

Locations (7)

Yale University; 🇺🇸 New Haven, Connecticut, United States

St. Luke's Cystic Fibrosis Center of Idaho; 🇺🇸 Boise, Idaho, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States

University of Texas Southwestern; 🇺🇸 Dallas, Texas, United States

Kansas University Medical Center; 🇺🇸 Kansas City, Kansas, United States

Washington University in St. Louis; 🇺🇸 Saint Louis, Missouri, United States