Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04869579
Recruitment Status : Not yet recruiting
First Posted : May 3, 2021
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Pharco Pharmaceuticals
Information provided by (Responsible Party):
Mohamed Ghoweba, MD, CHRISTUS Health

Tracking Information
First Submitted Date  ICMJE April 29, 2021
First Posted Date  ICMJE May 3, 2021
Last Update Posted Date May 5, 2021
Estimated Study Start Date  ICMJE June 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2021)
  • 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.
  • Rate of hospital discharges or deaths [ Time Frame: Study duration ]
    Rate of patient discharge to home or other long-term care facilities, or death.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Duration of hospitalization [ Time Frame: Day 1 though Day 29 ]
    Measured in days.
  • Incidence of new oxygen use [ Time Frame: Day 1 though Day 29 ]
    Incidence of new oxygen use.
  • Duration of new oxygen use [ Time Frame: Day 1 though Day 29 ]
    Measured in days.
  • 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.
  • Duration of new non-invasive ventilation or high flow oxygen use [ Time Frame: Day 1 though Day 29 ]
    Measured in days.
  • Incidence of new ventilator use [ Time Frame: Day 1 though Day 29 ]
    Incidence of new ventilator use.
  • Duration of new ventilator use [ Time Frame: Day 1 though Day 29 ]
    Measured in days.
  • Discontinuation or temporary suspension of investigational therapeutics [ Time Frame: Day 1 through Day 14 ]
    For any reason.
  • Change from baseline in alanine transaminase (ALT) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in alanine transaminase (ALT).
  • Change from baseline in aspartate transaminase (AST) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in aspartate transaminase (AST).
  • Change from baseline in creatinine (Cr) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in creatinine (Cr).
  • Change from baseline in glucose [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in glucose.
  • Change from baseline in hemoglobin [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in hemoglobin.
  • Change from baseline in platelets [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in platelets.
  • Change from baseline in prothrombin time [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in prothrombin time.
  • Change from baseline in total bilirubin [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in total bilirubin.
  • 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.
  • Change from baseline in interleukin-1 (IL-1) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in interleukin-1 (IL-1).
  • Change from baseline in interleukin-6 (IL-6) [ Time Frame: Day 1 through Day 29 ]
    Change from baseline in interleukin-6 (IL-6).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
Official Title  ICMJE Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Covid19
Intervention  ICMJE
  • Drug: Selenium (as Selenious Acid)
    Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
    Other Name: Selenious Acid (AMERICAN REGENT)
  • Other: Placebo
    Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
    Other Name: Saline-based Placebo
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Selenium (as Selenious Acid)
  • 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.
    Intervention: Other: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2021)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed S Ghoweba, MD 318-219-6701 mohamed.ghoweba@christushealth.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04869579
Other Study ID Numbers  ICMJE 2020-190
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: Clinical Study Report (CSR)
Supporting Materials: Analytic Code
Time Frame: Immediately following publication. No end date.
Access Criteria: Researchers who provide a methodologically sound proposal.
Responsible Party Mohamed Ghoweba, MD, CHRISTUS Health
Study Sponsor  ICMJE CHRISTUS Health
Collaborators  ICMJE Pharco Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Mohamed S Ghoweba, MD CHRISTUS Health
PRS Account CHRISTUS Health
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP