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SPI-1005 Treatment in Severe COVID-19 Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04483973
Recruitment Status : Enrolling by invitation
First Posted : July 23, 2020
Last Update Posted : November 8, 2022
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Covid19 Coronavirus Coronavirus Infection Corona Virus Infection Drug: Ebselen Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

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 Name: 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 Name: 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

Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. 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.

  2. Degree of supplemental oxygen [ Time Frame: 30 days ]
    Respiratory status assessed by degree of supplemental oxygen (e.g. mask oxygen, mechanical ventilation)

  3. Peripheral Oxygen Saturation (SpO2) [ Time Frame: 30 days ]
    Peripheral oxygen saturation measured by pulse oximetry

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04483973

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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 96510
United States, Idaho
St. Luke's Cystic Fibrosis Center of Idaho
Boise, Idaho, United States, 83702
United States, Kansas
Kansas University Medical Center
Kansas City, Kansas, United States, 66160
United States, Missouri
Washington University in St. Louis
Saint Louis, Missouri, United States, 63130
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27710
Wake Forest University
Winston-Salem, North Carolina, United States, 27109
United States, Texas
University of Texas Southwestern
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
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Principal Investigator: Miriam Treggiari, MD Yale University

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Responsible Party: Sound Pharmaceuticals, Incorporated
ClinicalTrials.gov Identifier: NCT04483973    
Other Study ID Numbers: SPI-1005-292
First Posted: July 23, 2020    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sound Pharmaceuticals, Incorporated:
main protease
papain-like protease
Additional relevant MeSH terms:
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Communicable Diseases
Coronavirus Infections
Disease Attributes
Pathologic Processes
Pneumonia, Viral
Respiratory Tract Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors