Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients. (SeCOVID)

July 30, 2021 updated by: Mohamed Ghoweba, MD, CHRISTUS Health

Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients

Given its anti-viral, anti-oxidative, immune-enhancing, cytokine-modulating, and anticoagulant properties, the investigators hypothesize that Selenium infusion at supranutritional doses for moderately-ill, severely-ill, and critically-ill COVID-19 patients will prevent further clinical deterioration thus decreasing overall mortality and improving survival. To test this hypothesis, a prospective, single-center, phase II trial is proposed to assess the efficacy of Selenium in hospitalized adult patients with moderate, severe, and critical COVID-19 infections.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

COVID-19 is a respiratory illness that is caused by the novel SARS-CoV-2. Illness severity can widely range from mild, moderate, severe featuring pneumonia, to critical. Despite ongoing extensive research to find a cure for COVID-19, there had been no proven, efficacious, and widely-available treatment for the disease. With the death toll rising in various parts of the US and the world, it is imperative that investigators work on determining new therapeutic modalities. This study relates to inpatient and critical care for COVID-19 patients.

The role of Selenium (Se) as a trace element involved in many biological processes and reactions is well established in various organisms. Particularly, Selenium is known to have anti-viral, anti-oxidative, cytokine-modulating, immune-enhancing, and anticoagulant properties that might be beneficial in COVID-19 infections given the pathophysiological processes involved in the disease. Multiple preclinical and clinical studies have shed the light on the various effects exerted by Selenium in multiple inflammatory conditions including acute lung injury and acute respiratory distress syndrome, as well as viral infections including HIV and Influenza. The study team aims to explore the possible role of Selenium in mitigating the inflammatory processes involved in COVID-19 infections and hence its effect on disease progression and mortality.

Patients with COVID-19 who exhibit the signs and symptoms of moderate or severe infection or are critically ill will receive Selenium infusion for 14 days. The working hypothesis of this trial is that selenium treatment would decrease the death rates and increase the rate of hospital discharges among hospitalized patients.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Willing and able to provide written informed consent, or with a legal representative who can provide informed consent, or enrolled under International Conference on Harmonization (ICH) E6(R2) 4.8.15 emergency use provisions as deemed necessary by the investigator (age ≥18) prior to performing study procedure.
  2. Aged ≥ 18 years.
  3. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization.
  4. Currently hospitalized.
  5. Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen on screening.

Exclusion Criteria:

  1. Participation in any other clinical trial of an experimental treatment for COVID-19.
  2. Evidence of multiorgan failure.
  3. Mechanically ventilated for > 5 days.
  4. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN).
  5. Creatinine clearance < 50 mL/min.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selenious Acid + Standard Of Care (SOC)
Participants who are moderately-ill, severely-ill, or critically ill will receive a Selenious Acid infusion of 2000µg on day 1 as a loading dose infusion, followed by a continuous infusion of Selenious Acid at a maintenance dose of 1000µg daily on days 2-14 together with continued Standard Of Care therapy.
Drug: Selenium (as Selenious Acid)
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
Other Names:
  • Selenious Acid (AMERICAN REGENT)
Active Comparator: Standard Of Care (SOC) + Placebo
Participants will receive a Saline-based placebo infusion of 2000µg on day 1 as a loading dose, followed by continuous infusion of a Saline-based placebo at a maintenance dose of 1000µg daily on days 2-14. Standard Of Care is to be determined according to patients' clinical picture and may include Dexamethasone, Azithromycin, Ceftriaxone, Remdesivir, Convalescent Plasma.
Other: Placebo
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
Other Names:
  • Saline-based Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean change in the ordinal scale
Time Frame: Day 1 through Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Day 1 through Day 29
Rate of hospital discharges or deaths
Time Frame: Study duration
Rate of patient discharge to home or other long-term care facilities, or death.
Study duration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical status using ordinal scale
Time Frame: Day 1 through Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Day 1 through Day 29
Mean change in the ordinal scale
Time Frame: Day 1 though Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Day 1 though Day 29
Time to an improvement of one category using an ordinal scale
Time Frame: Day 1 though Day 29
The ordinal scale is an assessment of the clinical status at the first assessment of a given study day. The scale is as follows: 1) Death; 2) Hospitalized, on invasive mechanical ventilation; 3) Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4) Hospitalized, requiring supplemental oxygen; 5) Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise); 6) Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7) Not hospitalized, limitation on activities and/or requiring home oxygen; 8) Not hospitalized, no limitations on activities.
Day 1 though Day 29
Change in National Early Warning Score (NEWS) from baseline
Time Frame: Day 1 through Day 29
The NEW score has demonstrated an ability to discriminate patients at risk of poor outcomes. This score is based on 7 clinical parameters (respiration rate, oxygen saturation, any supplemental oxygen, temperature, systolic blood pressure, heart rate, level of consciousness). The NEW Score is being used as an efficacy measure.
Day 1 through Day 29
Cumulative incidence of serious adverse events (SAEs)
Time Frame: Day 1 through Day 29
An SAE is defined as an AE or suspected adverse reaction is considered serious if, in the view of either the investigator, it results in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions.
Day 1 through Day 29
Duration of hospitalization
Time Frame: Day 1 though Day 29
Measured in days.
Day 1 though Day 29
Incidence of new oxygen use
Time Frame: Day 1 though Day 29
Incidence of new oxygen use.
Day 1 though Day 29
Duration of new oxygen use
Time Frame: Day 1 though Day 29
Measured in days.
Day 1 though Day 29
Incidence of new non-invasive ventilation or high flow oxygen use
Time Frame: Day 1 though Day 29
Incidence of new non-invasive ventilation or high flow oxygen use.
Day 1 though Day 29
Duration of new non-invasive ventilation or high flow oxygen use
Time Frame: Day 1 though Day 29
Measured in days.
Day 1 though Day 29
Incidence of new ventilator use
Time Frame: Day 1 though Day 29
Incidence of new ventilator use.
Day 1 though Day 29
Duration of new ventilator use
Time Frame: Day 1 though Day 29
Measured in days.
Day 1 though Day 29
Discontinuation or temporary suspension of investigational therapeutics
Time Frame: Day 1 through Day 14
For any reason.
Day 1 through Day 14
Change from baseline in alanine transaminase (ALT)
Time Frame: Day 1 through Day 29
Change from baseline in alanine transaminase (ALT).
Day 1 through Day 29
Change from baseline in aspartate transaminase (AST)
Time Frame: Day 1 through Day 29
Change from baseline in aspartate transaminase (AST).
Day 1 through Day 29
Change from baseline in creatinine (Cr)
Time Frame: Day 1 through Day 29
Change from baseline in creatinine (Cr).
Day 1 through Day 29
Change from baseline in glucose
Time Frame: Day 1 through Day 29
Change from baseline in glucose.
Day 1 through Day 29
Change from baseline in hemoglobin
Time Frame: Day 1 through Day 29
Change from baseline in hemoglobin.
Day 1 through Day 29
Change from baseline in platelets
Time Frame: Day 1 through Day 29
Change from baseline in platelets.
Day 1 through Day 29
Change from baseline in prothrombin time
Time Frame: Day 1 through Day 29
Change from baseline in prothrombin time.
Day 1 through Day 29
Change from baseline in total bilirubin
Time Frame: Day 1 through Day 29
Change from baseline in total bilirubin.
Day 1 through Day 29
Change from baseline in white blood cell count (WBC) with differential
Time Frame: Day 1 through Day 29
Change from baseline in white blood cell count (WBC) with differential.
Day 1 through Day 29
Change from baseline in interleukin-1 (IL-1)
Time Frame: Day 1 through Day 29
Change from baseline in interleukin-1 (IL-1).
Day 1 through Day 29
Change from baseline in interleukin-6 (IL-6)
Time Frame: Day 1 through Day 29
Change from baseline in interleukin-6 (IL-6).
Day 1 through Day 29
Change from baseline in tumor necrosis factor alpha (TNF-α)
Time Frame: Day 1 through Day 29
Change from baseline in tumor necrosis factor alpha (TNF-α).
Day 1 through Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CHRISTUS Health

Collaborators

Pharco Pharmaceuticals

Investigators

  • Principal Investigator: Mohamed S Ghoweba, MD, CHRISTUS Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 15, 2021

Primary Completion (Anticipated)

November 15, 2021

Study Completion (Anticipated)

December 15, 2021

Study Registration Dates

First Submitted

April 29, 2021

First Submitted That Met QC Criteria

April 29, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Actual)

August 3, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Individual participant data that underlie the results reported in the publication(s) after deidentification (text, tables, figures, and appendices). Proposals should be directed to mohamed.ghoweba@christushealth.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)
  • Analytic Code

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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