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

Covid19 Clinical Trial

— SeCOVID  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04869579
• Other study ID #: 2020-190
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 15, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: July 2021
• Source: CHRISTUS Health
• Contact: Mohamed S Ghoweba, MD
• Phone: 318-219-6701
• Email: mohamed.ghoweba[@]christushealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 15, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Covid19
• Critical Illness

Intervention

Drug:
• Selenium (as Selenious Acid)
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.

Other:
• Placebo
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.

Locations

Country	Name	City	State
United States	CHRISTUS Good Shepherd Medical Center	Longview	Texas

Sponsors (2)

Lead Sponsor	Collaborator
CHRISTUS Health	Pharco Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (58)

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* Note: There are 58 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Day 1 through Day 29
Primary	Rate of hospital discharges or deaths	Rate of patient discharge to home or other long-term care facilities, or death.	Study duration
Secondary	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.	Day 1 through Day 29
Secondary	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.	Day 1 though Day 29
Secondary	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.	Day 1 though Day 29
Secondary	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.	Day 1 through Day 29
Secondary	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.	Day 1 through Day 29
Secondary	Duration of hospitalization	Measured in days.	Day 1 though Day 29
Secondary	Incidence of new oxygen use	Incidence of new oxygen use.	Day 1 though Day 29
Secondary	Duration of new oxygen use	Measured in days.	Day 1 though Day 29
Secondary	Incidence of new non-invasive ventilation or high flow oxygen use	Incidence of new non-invasive ventilation or high flow oxygen use.	Day 1 though Day 29
Secondary	Duration of new non-invasive ventilation or high flow oxygen use	Measured in days.	Day 1 though Day 29
Secondary	Incidence of new ventilator use	Incidence of new ventilator use.	Day 1 though Day 29
Secondary	Duration of new ventilator use	Measured in days.	Day 1 though Day 29
Secondary	Discontinuation or temporary suspension of investigational therapeutics	For any reason.	Day 1 through Day 14
Secondary	Change from baseline in alanine transaminase (ALT)	Change from baseline in alanine transaminase (ALT).	Day 1 through Day 29
Secondary	Change from baseline in aspartate transaminase (AST)	Change from baseline in aspartate transaminase (AST).	Day 1 through Day 29
Secondary	Change from baseline in creatinine (Cr)	Change from baseline in creatinine (Cr).	Day 1 through Day 29
Secondary	Change from baseline in glucose	Change from baseline in glucose.	Day 1 through Day 29
Secondary	Change from baseline in hemoglobin	Change from baseline in hemoglobin.	Day 1 through Day 29
Secondary	Change from baseline in platelets	Change from baseline in platelets.	Day 1 through Day 29
Secondary	Change from baseline in prothrombin time	Change from baseline in prothrombin time.	Day 1 through Day 29
Secondary	Change from baseline in total bilirubin	Change from baseline in total bilirubin.	Day 1 through Day 29
Secondary	Change from baseline in white blood cell count (WBC) with differential	Change from baseline in white blood cell count (WBC) with differential.	Day 1 through Day 29
Secondary	Change from baseline in interleukin-1 (IL-1)	Change from baseline in interleukin-1 (IL-1).	Day 1 through Day 29
Secondary	Change from baseline in interleukin-6 (IL-6)	Change from baseline in interleukin-6 (IL-6).	Day 1 through Day 29
Secondary	Change from baseline in tumor necrosis factor alpha (TNF-a)	Change from baseline in tumor necrosis factor alpha (TNF-a).	Day 1 through Day 29