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Trial · Interventional

CompletedPhase 2Results postedRegistry data

SPI-1005 Treatment in Severe COVID-19 Patients

NCTNCT04483973 (opens ClinicalTrials.gov in a new tab)Other idSPI-1005-292
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Names Glutathione, does not test it. It appears in the description.

Overview

Status
Completed
Phase
Phase 2
Enrollment
25 participants (actual)
Sponsor
Sound Pharmaceuticals, Incorporated · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
27 Aug 2021
Primary completion
5 May 2023
Completion
6 Jun 2023
First posted
23 Jul 2020
Last update posted
29 Jun 2026
Conditions
Covid19 · Coronavirus · Coronavirus Infection · Corona Virus Infection

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2021202220232024
  1. Ph 2

    SPI-1005 Treatment in Severe COVID-19 Patients

    NCT04483973

    27 Aug 2021 to 6 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • EbselenDrug
  • PlaceboDrug

Arms2

  • Placebo comparator

    Placebo

    Oral administration of matching placebo BID for 14 days, with 30-day follow-up

  • Active comparator

    SPI-1005 400 mg BID

    Oral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Participants With Treatment-related Adverse Events

    Time frame · 30 days

    Registry description

    Number of participants with adverse events, categorized by Common Terminology Criteria for Adverse Events (CTCAE) grading for severity.

Secondary outcomes(1)

  1. WHO Ordinal Scale

    Time frame · 30 days

    Registry description

    Clinical outcome assessed by WHO Ordinal Scale for Clinical Improvement. Scale is 0-8 where higher score is worse outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 30 days

Number of Participants With Treatment-related Adverse Events

GroupValue (participants)
Placebo2
SPI-1005 400 mg BID6
Secondary and other outcome results(1)
Secondary outcomeMean· 30 days

WHO Ordinal Scale

GroupValue (units on a scale)Spread
Placebo2.332.42
SPI-1005 400 mg BID2.642.01

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboOral administration of matching placebo BID for 14 days, with 30-day follow-up Placebo: Matching placebo containing excipients1 / 93 / 91 / 9
SPI-1005 400 mg BIDOral administration of SPI-1005 400 mg BID for 14 days, with 30-day follow-up Ebselen: Glutathione peroxidase mimetic4 / 165 / 168 / 16

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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