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OpenTrials
Enrolling by Invitation

NCT Number: NCT04484025

SPI-1005 Treatment in Moderate 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 moderate symptoms of COVID-19 disease.

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Key information

Conditions

Covid19 COVID-19 Corona Virus Infection Coronaviridae Infections Coronavirus Coronavirus Infection Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Yale University, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 moderate COVID-19
  • Score of 3-4 on the WHO Ordinal Scale
  • Onset of moderate COVID-19 symptoms ≤3 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.

Treatment and study plan

Ebselen

Drug

Glutathione peroxidase mimetic

Other names: SPI-1005

Placebo

Drug

Matching placebo containing excipients

Primary outcomes

  1. Number of participants with treatment-related adverse events

    Time frame: 30 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sound Pharmaceuticals, Incorporated

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of SPI-1005 in Moderate COVID-19 Patients

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2020
Registry last updated
Oct 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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