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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04483973
Recruitment Status : Not yet recruiting
First Posted : July 23, 2020
Last Update Posted : November 10, 2020
Sponsor:
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
Estimated Study Start Date : December 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2021

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

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

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
  • Severe disease: requiring mechanical ventilation or oxygen, a SpO2 ≤ 94% on room air, or tachypnoea (respiratory rate ≥ 24 breaths/min)
  • Symptom onset ≤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

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


Contacts
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Contact: Jonathan Kil, MD 2066342559 info@soundpharma.com

Sponsors and Collaborators
Sound Pharmaceuticals, Incorporated
Investigators
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Principal Investigator: Miriam Treggiari, MD Yale University
Principal Investigator: Haifan Lin, PhD Yale University
Publications:
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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 10, 2020
Last Verified: November 2020
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:
ebselen
SPI-1005
COVID-19
Covid
SARS-COV-2
Mpro
main protease
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Ebselen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Neuroprotective Agents