SPI-1005 Treatment in Severe COVID-19 Patients

October 2, 2023 updated by: Sound Pharmaceuticals, Incorporated

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

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 96510
        • Yale University
    • Idaho
      • Boise, Idaho, United States, 83702
        • St. Luke's Cystic Fibrosis Center of Idaho
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63130
        • Washington University in St. Louis
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University
      • Winston-Salem, North Carolina, United States, 27109
        • Wake Forest University
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SPI-1005 400 mg BID
Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up
Drug: Ebselen
Glutathione peroxidase mimetic
Other Names:
  • SPI-1005
Experimental: SPI-1005 800 mg BID
Oral administration of SPI-1005 800 mg BID for 14 days, with 30-day follow-up
Drug: Ebselen
Glutathione peroxidase mimetic
Other Names:
  • SPI-1005
Placebo Comparator: Placebo
Oral administration of matching placebo BID for 14 days, with 30-day follow-up
Drug: Placebo
Matching placebo containing excipients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events
Time Frame: 30 days
30 days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sound Pharmaceuticals, Incorporated

Investigators

  • Principal Investigator: Miriam Treggiari, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 27, 2021

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 13, 2020

First Submitted That Met QC Criteria

July 21, 2020

First Posted (Actual)

July 23, 2020

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-1005-292

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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