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Experimental drug aims to tame severe COVID-19 inflammation

NCT ID NCT04483973

Disease control Sponsor: Sound Pharmaceuticals, Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study tests an experimental drug called SPI-1005 (ebselen) in adults hospitalized with severe COVID-19. Participants receive either the drug or a placebo to see if the drug is safe and helps improve recovery. The trial is randomized and double-blind, meaning neither patients nor doctors know who gets the real drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ebselen (SPI-1005)
What this could lead to
If it works, this could point toward a new treatment option for severe COVID-19 that reduces inflammation and speeds recovery.
What could go wrong
This is a small, early-phase trial, so results may not apply broadly. The drug may cause side effects or prove no better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

25 people

The number who actually took part.

Started

Aug 2021

Finished

Jun 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Coronavinae infectious disease COVID-19 Orthocoronavirinae infectious disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corona virus infection Coronavirus Coronavirus infection COVID19

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27710, United States

  • Kansas University Medical Center

    Kansas City, Kansas, 66160, United States

  • St. Luke's Cystic Fibrosis Center of Idaho

    Boise, Idaho, 83702, United States

  • University of Texas Southwestern

    Dallas, Texas, 75390, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27109, United States

  • Washington University in St. Louis

    St Louis, Missouri, 63130, United States

  • Yale University

    New Haven, Connecticut, 96510, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.