Covid19Phase 2SeCOVIDNCT04869579
Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
A Phase 2 study testing Selenium (as Selenious Acid) in people with Covid19, run by CHRISTUS Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Selenium (as Selenious Acid)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 15 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
CHRISTUS Good Shepherd Medical Center
Longview, Texas, 75601
Mohamed Ghoweba, MD, 318-219-6701, mohamed.ghoweba@christushealth.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Covid19
- Being tested
- Selenium (as Selenious Acid), Placebo
- Keywords
- COVID-19 Pneumonia, Cytokine Storm, ARDS, Moderate COVID-19 Infections, Severe COVID-19 Infections, Critical COVID-19 Infections, Selenium
- Medical subject headings
- COVID-19, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selenium (as Selenious Acid)Drug
Also called Selenious Acid (AMERICAN REGENT)
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
PlaceboOther
Also called Saline-based Placebo
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
| Study group | Role | What they receive |
|---|---|---|
| Selenious Acid + Standard Of Care (SOC) | Experimental | 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. Receives: Drug: Selenium (as Selenious Acid) |
| Standard Of Care (SOC) + Placebo | Active comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Study duration
Secondary outcomes (25)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 1 through Day 29
Duration of hospitalization
Measured in days.
Measured: Day 1 though Day 29
Incidence of new oxygen use
Incidence of new oxygen use.
Measured: Day 1 though Day 29
Duration of new oxygen use
Measured in days.
Measured: 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.
Measured: Day 1 though Day 29
Duration of new non-invasive ventilation or high flow oxygen use
Measured in days.
Measured: Day 1 though Day 29
Incidence of new ventilator use
Incidence of new ventilator use.
Measured: Day 1 though Day 29
Duration of new ventilator use
Measured in days.
Measured: Day 1 though Day 29
Discontinuation or temporary suspension of investigational therapeutics
For any reason.
Measured: Day 1 through Day 14
Change from baseline in alanine transaminase (ALT)
Change from baseline in alanine transaminase (ALT).
Measured: Day 1 through Day 29
Change from baseline in aspartate transaminase (AST)
Change from baseline in aspartate transaminase (AST).
Measured: Day 1 through Day 29
Change from baseline in creatinine (Cr)
Change from baseline in creatinine (Cr).
Measured: Day 1 through Day 29
Change from baseline in glucose
Change from baseline in glucose.
Measured: Day 1 through Day 29
Change from baseline in hemoglobin
Change from baseline in hemoglobin.
Measured: Day 1 through Day 29
Change from baseline in platelets
Change from baseline in platelets.
Measured: Day 1 through Day 29
Change from baseline in prothrombin time
Change from baseline in prothrombin time.
Measured: Day 1 through Day 29
Change from baseline in total bilirubin
Change from baseline in total bilirubin.
Measured: 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.
Measured: Day 1 through Day 29
Change from baseline in interleukin-1 (IL-1)
Change from baseline in interleukin-1 (IL-1).
Measured: Day 1 through Day 29
Change from baseline in interleukin-6 (IL-6)
Change from baseline in interleukin-6 (IL-6).
Measured: 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).
Measured: Day 1 through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start15 Aug 2021 (estimated)
- Primary completion15 Nov 2021 (estimated)
- Study completion15 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (58)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHRISTUS Health
- Sponsor type
- University, hospital or other
- Collaborators
- Pharco Pharmaceuticals
- Responsible party
- Principal investigator, Mohamed Ghoweba, MD, CHRISTUS Health
- Investigators
- Mohamed S Ghoweba, MD, Principal investigator, CHRISTUS Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869579
- Sponsor's protocol ID
- 2020-190
- Acronym
- SeCOVID
- Status last verified
- Jul 2021
- First submitted
- 29 Apr 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Perona G, Schiavon R, Guidi GC, Veneri D, Minuz P. Selenium dependent glutathione peroxidase: a physiological regulatory system for platelet function. Thromb Haemost. 1990 Oct 22;64(2):312-8.
PubMed 2270539Steinbrenner H, Sies H. Protection against reactive oxygen species by selenoproteins. Biochim Biophys Acta. 2009 Nov;1790(11):1478-85. doi: 10.1016/j.bbagen.2009.02.014. Epub 2009 Mar 5.
PubMed 19268692Steinbrenner H, Speckmann B, Klotz LO. Selenoproteins: Antioxidant selenoenzymes and beyond. Arch Biochem Biophys. 2016 Apr 1;595:113-9. doi: 10.1016/j.abb.2015.06.024.
PubMed 27095226Avery JC, Hoffmann PR. Selenium, Selenoproteins, and Immunity. Nutrients. 2018 Sep 1;10(9):1203. doi: 10.3390/nu10091203.
PubMed 30200430Hassanzadeh M, Faridhosseini R, Mahini M, Faridhosseini F, Ranjbar A. Serum Levels of TNF-, IL-6, and Selenium in Patients with Acute and Chronic Coronary Artery Disease. Iran J Immunol. 2006 Sep;3(3):142-5. doi: 10.22034/iji.2006.16988.
PubMed 18698124Zhou X, Wang Z, Chen J, Wang W, Song D, Li S, Yang H, Xue S, Chen C. Increased levels of IL-6, IL-1beta, and TNF-alpha in Kashin-Beck disease and rats induced by T-2 toxin and selenium deficiency. Rheumatol Int. 2014 Jul;34(7):995-1004. doi: 10.1007/s00296-013-2862-5. Epub 2013 Sep 15.
PubMed 24037056Gazi MH, Gong A, Donkena KV, Young CY. Sodium selenite inhibits interleukin-6-mediated androgen receptor activation in prostate cancer cells via upregulation of c-Jun. Clin Chim Acta. 2007 May 1;380(1-2):145-50. doi: 10.1016/j.cca.2007.01.031. Epub 2007 Feb 11.
PubMed 17346688Hoffmann PR, Berry MJ. The influence of selenium on immune responses. Mol Nutr Food Res. 2008 Nov;52(11):1273-80. doi: 10.1002/mnfr.200700330.
PubMed 18384097Steinbrenner H, Al-Quraishy S, Dkhil MA, Wunderlich F, Sies H. Dietary selenium in adjuvant therapy of viral and bacterial infections. Adv Nutr. 2015 Jan 15;6(1):73-82. doi: 10.3945/an.114.007575. Print 2015 Jan.
PubMed 25593145Beck MA, Levander OA, Handy J. Selenium deficiency and viral infection. J Nutr. 2003 May;133(5 Suppl 1):1463S-7S. doi: 10.1093/jn/133.5.1463S.
PubMed 12730444Beck MA. Selenium and host defence towards viruses. Proc Nutr Soc. 1999 Aug;58(3):707-11. doi: 10.1017/s0029665199000920.
PubMed 10604206Beck MA. Antioxidants and viral infections: host immune response and viral pathogenicity. J Am Coll Nutr. 2001 Oct;20(5 Suppl):384S-388S; discussion 396S-397S. doi: 10.1080/07315724.2001.10719172.
PubMed 11603647Schrauzer GN, Sacher J. Selenium in the maintenance and therapy of HIV-infected patients. Chem Biol Interact. 1994 Jun;91(2-3):199-205. doi: 10.1016/0009-2797(94)90040-x.
PubMed 7514960Hori K, Hatfield D, Maldarelli F, Lee BJ, Clouse KA. Selenium supplementation suppresses tumor necrosis factor alpha-induced human immunodeficiency virus type 1 replication in vitro. AIDS Res Hum Retroviruses. 1997 Oct 10;13(15):1325-32. doi: 10.1089/aid.1997.13.1325.
PubMed 9339849Zheng YY, Ma YT, Zhang JY, Xie X. COVID-19 and the cardiovascular system. Nat Rev Cardiol. 2020 May;17(5):259-260. doi: 10.1038/s41569-020-0360-5.
PubMed 32139904
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients
- ClinicalTrials.gov ID
- NCT04869579
- Acronym / sponsor ID
- SeCOVID / 2020-190
- Conditions
- Covid19
- Keywords
- COVID-19 Pneumonia, Cytokine Storm, ARDS, Moderate COVID-19 Infections, Severe COVID-19 Infections, Critical COVID-19 Infections, Selenium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- CHRISTUS HealthUniversity, hospital or other
- Collaborators
- Pharco Pharmaceuticals
- Study start
- 15 Aug 2021 (estimated)
- Primary completion
- 15 Nov 2021 (estimated)
- Study completion
- 15 Dec 2021 (estimated)
- First posted
- 3 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Selenious Acid + Standard Of Care (SOC) | Experimental | Drug: Selenium (as Selenious Acid)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. |
| Standard Of Care (SOC) + Placebo | Active comparator | Other: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selenium (as Selenious Acid)Also: Selenious Acid (AMERICAN REGENT)Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy. | Drug | Selenious Acid + Standard Of Care (SOC) |
| PlaceboAlso: Saline-based PlaceboActive comparator arm participants will receive the standard of care therapy plus a Saline-based placebo. | Other | Standard Of Care (SOC) + Placebo |
Primary outcome
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.
25 secondary outcomes
Clinical status using ordinal scale
Time frame: Day 1 through Day 29
Mean change in the ordinal scale
Time frame: Day 1 though Day 29
Time to an improvement of one category using an ordinal scale
Time frame: Day 1 though Day 29
Change in National Early Warning Score (NEWS) from baseline
Time frame: Day 1 through Day 29
Cumulative incidence of serious adverse events (SAEs)
Time frame: Day 1 through Day 29
Duration of hospitalization
Time frame: Day 1 though Day 29
Incidence of new oxygen use
Time frame: Day 1 though Day 29
Duration of new oxygen use
Time frame: Day 1 though Day 29
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
Time frame: Day 1 though Day 29
Incidence of new ventilator use
Time frame: Day 1 though Day 29
Duration of new ventilator use
Time frame: Day 1 though Day 29
Discontinuation or temporary suspension of investigational therapeutics
Time frame: Day 1 through Day 14
Change from baseline in alanine transaminase (ALT)
Time frame: Day 1 through Day 29
Change from baseline in aspartate transaminase (AST)
Time frame: Day 1 through Day 29
Change from baseline in creatinine (Cr)
Time frame: Day 1 through Day 29
Change from baseline in glucose
Time frame: Day 1 through Day 29
Change from baseline in hemoglobin
Time frame: Day 1 through Day 29
Change from baseline in platelets
Time frame: Day 1 through Day 29
Change from baseline in prothrombin time
Time frame: Day 1 through Day 29
Change from baseline in total bilirubin
Time frame: 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 interleukin-1 (IL-1)
Time frame: Day 1 through Day 29
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)
Time frame: Day 1 through Day 29
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 2270539Perona G, Schiavon R, Guidi GC, Veneri D, Minuz P. Selenium dependent glutathione peroxidase: a physiological regulatory system for platelet function. Thromb Haemost. 1990 Oct 22;64(2):312-8.
- Background: PubMed 19268692Steinbrenner H, Sies H. Protection against reactive oxygen species by selenoproteins. Biochim Biophys Acta. 2009 Nov;1790(11):1478-85. doi: 10.1016/j.bbagen.2009.02.014. Epub 2009 Mar 5.
- Background: PubMed 27095226Steinbrenner H, Speckmann B, Klotz LO. Selenoproteins: Antioxidant selenoenzymes and beyond. Arch Biochem Biophys. 2016 Apr 1;595:113-9. doi: 10.1016/j.abb.2015.06.024.
- Background: PubMed 30200430Avery JC, Hoffmann PR. Selenium, Selenoproteins, and Immunity. Nutrients. 2018 Sep 1;10(9):1203. doi: 10.3390/nu10091203.
- Background: PubMed 18698124Hassanzadeh M, Faridhosseini R, Mahini M, Faridhosseini F, Ranjbar A. Serum Levels of TNF-, IL-6, and Selenium in Patients with Acute and Chronic Coronary Artery Disease. Iran J Immunol. 2006 Sep;3(3):142-5. doi: 10.22034/iji.2006.16988.
- Background: PubMed 24037056Zhou X, Wang Z, Chen J, Wang W, Song D, Li S, Yang H, Xue S, Chen C. Increased levels of IL-6, IL-1beta, and TNF-alpha in Kashin-Beck disease and rats induced by T-2 toxin and selenium deficiency. Rheumatol Int. 2014 Jul;34(7):995-1004. doi: 10.1007/s00296-013-2862-5. Epub 2013 Sep 15.
- Background: PubMed 17346688Gazi MH, Gong A, Donkena KV, Young CY. Sodium selenite inhibits interleukin-6-mediated androgen receptor activation in prostate cancer cells via upregulation of c-Jun. Clin Chim Acta. 2007 May 1;380(1-2):145-50. doi: 10.1016/j.cca.2007.01.031. Epub 2007 Feb 11.
- Background: PubMed 18384097Hoffmann PR, Berry MJ. The influence of selenium on immune responses. Mol Nutr Food Res. 2008 Nov;52(11):1273-80. doi: 10.1002/mnfr.200700330.
- Background: PubMed 25593145Steinbrenner H, Al-Quraishy S, Dkhil MA, Wunderlich F, Sies H. Dietary selenium in adjuvant therapy of viral and bacterial infections. Adv Nutr. 2015 Jan 15;6(1):73-82. doi: 10.3945/an.114.007575. Print 2015 Jan.
- Background: PubMed 12730444Beck MA, Levander OA, Handy J. Selenium deficiency and viral infection. J Nutr. 2003 May;133(5 Suppl 1):1463S-7S. doi: 10.1093/jn/133.5.1463S.
- Background: PubMed 10604206Beck MA. Selenium and host defence towards viruses. Proc Nutr Soc. 1999 Aug;58(3):707-11. doi: 10.1017/s0029665199000920.
- Background: PubMed 11603647Beck MA. Antioxidants and viral infections: host immune response and viral pathogenicity. J Am Coll Nutr. 2001 Oct;20(5 Suppl):384S-388S; discussion 396S-397S. doi: 10.1080/07315724.2001.10719172.
- Individual participant dataSharing planned: 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.
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Vaccine Responses to SARS-CoV-2 and Other Emerging Infectious Diseases
COVID-19, Vaccination
RecruitingPhase 4
Comparative Immunogenicity of Respiratory Virus Vaccines (CIRV2) Study
COVID -19, COVID - 19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
RecruitingObservational study
Clinical Outcomes and Pharmacotherapy Effectiveness in the VA Health Care System (COPE-VA)
COVID-19, SARS-CoV-2 Infection, RSV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed S Ghoweba, MD principal investigator
CHRISTUS Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Selenium (as Selenious Acid) in people with Covid19, run by CHRISTUS Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed S Ghoweba, MD (318-219-6701, mohamed.ghoweba@christushealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in the ordinal scale (time frame: Day 1 through Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04869579, which also lists 58 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.