A Phase 2 interventional study of Selenium (as Selenious Acid) and Placebo in Covid19, sponsored by CHRISTUS Health. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-03.
Sponsored by CHRISTUS Health · Phase 2, Interventional, and Treatment
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 100 is close to the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →CHRISTUS Health is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
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)
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
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
Also known as: Selenious Acid (AMERICAN REGENT)
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
Also known as: Saline-based Placebo
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 frame: Day 1 through Day 29
Rate of hospital discharges or deaths
Rate of patient discharge to home or other long-term care facilities, or death.
Time frame: Study duration
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.
Time frame: Day 1 through Day 29
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 frame: Day 1 though Day 29
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.
Time frame: Day 1 though Day 29
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.
Time frame: Day 1 through Day 29
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.
Time frame: Day 1 through Day 29
Duration of hospitalization
Measured in days.
Time frame: Day 1 though Day 29
Incidence of new oxygen use
Incidence of new oxygen use.
Time frame: Day 1 though Day 29
Duration of new oxygen use
Measured in days.
Time frame: Day 1 though Day 29
Incidence of new non-invasive ventilation or high flow oxygen use
Incidence of new non-invasive ventilation or high flow oxygen use.
Time frame: Day 1 though Day 29
Duration of new non-invasive ventilation or high flow oxygen use
Measured in days.
Time frame: Day 1 though Day 29
Incidence of new ventilator use
Incidence of new ventilator use.
Time frame: Day 1 though Day 29
Duration of new ventilator use
Measured in days.
Time frame: Day 1 though Day 29
Discontinuation or temporary suspension of investigational therapeutics
For any reason.
Time frame: Day 1 through Day 14
Change from baseline in alanine transaminase (ALT)
Change from baseline in alanine transaminase (ALT).
Time frame: Day 1 through Day 29
Change from baseline in aspartate transaminase (AST)
Change from baseline in aspartate transaminase (AST).
Time frame: Day 1 through Day 29
Change from baseline in creatinine (Cr)
Change from baseline in creatinine (Cr).
Time frame: Day 1 through Day 29
Change from baseline in glucose
Change from baseline in glucose.
Time frame: Day 1 through Day 29
Change from baseline in hemoglobin
Change from baseline in hemoglobin.
Time frame: Day 1 through Day 29
Change from baseline in platelets
Change from baseline in platelets.
Time frame: Day 1 through Day 29
Change from baseline in prothrombin time
Change from baseline in prothrombin time.
Time frame: Day 1 through Day 29
Change from baseline in total bilirubin
Change from baseline in total bilirubin.
Time frame: Day 1 through Day 29
Change from baseline in white blood cell count (WBC) with differential
Change from baseline in white blood cell count (WBC) with differential.
Time frame: Day 1 through Day 29
Change from baseline in interleukin-1 (IL-1)
Change from baseline in interleukin-1 (IL-1).
Time frame: Day 1 through Day 29
Change from baseline in interleukin-6 (IL-6)
Change from baseline in interleukin-6 (IL-6).
Time frame: Day 1 through Day 29
Change from baseline in tumor necrosis factor alpha (TNF-α)
Change from baseline in tumor necrosis factor alpha (TNF-α).
Time frame: Day 1 through Day 29
Plan to share: Yes — 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 information: Study protocol, Sap, Icf, Csr, Analytic code
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