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

Primary Purpose

Covid19

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Selenium (as Selenious Acid)
Placebo
Sponsored by
CHRISTUS Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Covid19 focused on measuring COVID-19 Pneumonia, Cytokine Storm, ARDS, Moderate COVID-19 Infections, Severe COVID-19 Infections, Critical COVID-19 Infections, Selenium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHRISTUS Good Shepherd Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Selenious Acid + Standard Of Care (SOC)

Standard Of Care (SOC) + Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Mean change in the ordinal scale
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.
Rate of hospital discharges or deaths
Rate of patient discharge to home or other long-term care facilities, or death.

Secondary Outcome Measures

Clinical status using ordinal scale
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.
Mean change in the ordinal scale
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.
Time to an improvement of one category using an ordinal scale
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.
Change in National Early Warning Score (NEWS) from baseline
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.
Cumulative incidence of serious adverse events (SAEs)
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.
Duration of hospitalization
Measured in days.
Incidence of new oxygen use
Incidence of new oxygen use.
Duration of new oxygen use
Measured in days.
Incidence of new non-invasive ventilation or high flow oxygen use
Incidence of new non-invasive ventilation or high flow oxygen use.
Duration of new non-invasive ventilation or high flow oxygen use
Measured in days.
Incidence of new ventilator use
Incidence of new ventilator use.
Duration of new ventilator use
Measured in days.
Discontinuation or temporary suspension of investigational therapeutics
For any reason.
Change from baseline in alanine transaminase (ALT)
Change from baseline in alanine transaminase (ALT).
Change from baseline in aspartate transaminase (AST)
Change from baseline in aspartate transaminase (AST).
Change from baseline in creatinine (Cr)
Change from baseline in creatinine (Cr).
Change from baseline in glucose
Change from baseline in glucose.
Change from baseline in hemoglobin
Change from baseline in hemoglobin.
Change from baseline in platelets
Change from baseline in platelets.
Change from baseline in prothrombin time
Change from baseline in prothrombin time.
Change from baseline in total bilirubin
Change from baseline in total bilirubin.
Change from baseline in white blood cell count (WBC) with differential
Change from baseline in white blood cell count (WBC) with differential.
Change from baseline in interleukin-1 (IL-1)
Change from baseline in interleukin-1 (IL-1).
Change from baseline in interleukin-6 (IL-6)
Change from baseline in interleukin-6 (IL-6).
Change from baseline in tumor necrosis factor alpha (TNF-α)
Change from baseline in tumor necrosis factor alpha (TNF-α).

Full Information

First Posted
April 29, 2021
Last Updated
July 30, 2021
Sponsor
CHRISTUS Health
Collaborators
Pharco Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT04869579
Brief Title
Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
Acronym
SeCOVID
Official Title
Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2021 (Anticipated)
Primary Completion Date
November 15, 2021 (Anticipated)
Study Completion Date
December 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
CHRISTUS Health
Collaborators
Pharco Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
COVID-19 Pneumonia, Cytokine Storm, ARDS, Moderate COVID-19 Infections, Severe COVID-19 Infections, Critical COVID-19 Infections, Selenium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized double-blinded, placebo-controlled Phase 2 clinical trial to assess the efficacy of Selenium in the treatment of moderately-ill, severely-ill, and critically ill COVID-19 patients. The patients will be randomized in a 1:1 ratio to receive standard of care plus a loading dose of Selenium followed by continuous infusion for a total of 14 days, or standard of care plus a Saline-based placebo.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Selenious Acid + Standard Of Care (SOC)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Of Care (SOC) + Placebo
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Selenium (as Selenious Acid)
Other Intervention Name(s)
Selenious Acid (AMERICAN REGENT)
Intervention Description
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline-based Placebo
Intervention Description
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
Primary Outcome Measure Information:
Title
Mean change in the ordinal scale
Description
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.
Time Frame
Day 1 through Day 29
Title
Rate of hospital discharges or deaths
Description
Rate of patient discharge to home or other long-term care facilities, or death.
Time Frame
Study duration
Secondary Outcome Measure Information:
Title
Clinical status using ordinal scale
Description
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.
Time Frame
Day 1 through Day 29
Title
Mean change in the ordinal scale
Description
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.
Time Frame
Day 1 though Day 29
Title
Time to an improvement of one category using an ordinal scale
Description
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.
Time Frame
Day 1 though Day 29
Title
Change in National Early Warning Score (NEWS) from baseline
Description
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.
Time Frame
Day 1 through Day 29
Title
Cumulative incidence of serious adverse events (SAEs)
Description
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.
Time Frame
Day 1 through Day 29
Title
Duration of hospitalization
Description
Measured in days.
Time Frame
Day 1 though Day 29
Title
Incidence of new oxygen use
Description
Incidence of new oxygen use.
Time Frame
Day 1 though Day 29
Title
Duration of new oxygen use
Description
Measured in days.
Time Frame
Day 1 though Day 29
Title
Incidence of new non-invasive ventilation or high flow oxygen use
Description
Incidence of new non-invasive ventilation or high flow oxygen use.
Time Frame
Day 1 though Day 29
Title
Duration of new non-invasive ventilation or high flow oxygen use
Description
Measured in days.
Time Frame
Day 1 though Day 29
Title
Incidence of new ventilator use
Description
Incidence of new ventilator use.
Time Frame
Day 1 though Day 29
Title
Duration of new ventilator use
Description
Measured in days.
Time Frame
Day 1 though Day 29
Title
Discontinuation or temporary suspension of investigational therapeutics
Description
For any reason.
Time Frame
Day 1 through Day 14
Title
Change from baseline in alanine transaminase (ALT)
Description
Change from baseline in alanine transaminase (ALT).
Time Frame
Day 1 through Day 29
Title
Change from baseline in aspartate transaminase (AST)
Description
Change from baseline in aspartate transaminase (AST).
Time Frame
Day 1 through Day 29
Title
Change from baseline in creatinine (Cr)
Description
Change from baseline in creatinine (Cr).
Time Frame
Day 1 through Day 29
Title
Change from baseline in glucose
Description
Change from baseline in glucose.
Time Frame
Day 1 through Day 29
Title
Change from baseline in hemoglobin
Description
Change from baseline in hemoglobin.
Time Frame
Day 1 through Day 29
Title
Change from baseline in platelets
Description
Change from baseline in platelets.
Time Frame
Day 1 through Day 29
Title
Change from baseline in prothrombin time
Description
Change from baseline in prothrombin time.
Time Frame
Day 1 through Day 29
Title
Change from baseline in total bilirubin
Description
Change from baseline in total bilirubin.
Time Frame
Day 1 through Day 29
Title
Change from baseline in white blood cell count (WBC) with differential
Description
Change from baseline in white blood cell count (WBC) with differential.
Time Frame
Day 1 through Day 29
Title
Change from baseline in interleukin-1 (IL-1)
Description
Change from baseline in interleukin-1 (IL-1).
Time Frame
Day 1 through Day 29
Title
Change from baseline in interleukin-6 (IL-6)
Description
Change from baseline in interleukin-6 (IL-6).
Time Frame
Day 1 through Day 29
Title
Change from baseline in tumor necrosis factor alpha (TNF-α)
Description
Change from baseline in tumor necrosis factor alpha (TNF-α).
Time Frame
Day 1 through Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Aged ≥ 18 years. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test ≤ 4 days before randomization. Currently hospitalized. Peripheral capillary oxygen saturation (SpO2) ≤ 94% or requiring supplemental oxygen on screening. Exclusion Criteria: Participation in any other clinical trial of an experimental treatment for COVID-19. Evidence of multiorgan failure. Mechanically ventilated for > 5 days. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN). Creatinine clearance < 50 mL/min.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed S Ghoweba, MD
Phone
318-219-6701
Email
mohamed.ghoweba@christushealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed S Ghoweba, MD
Organizational Affiliation
CHRISTUS Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRISTUS Good Shepherd Medical Center
City
Longview
State/Province
Texas
ZIP/Postal Code
75601
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed Ghoweba, MD
Phone
318-219-6701
Email
mohamed.ghoweba@christushealth.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
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Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.

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