Selenium as a Potential Treatment for Moderately-ill, Severely-ill, and Critically-ill COVID-19 Patients.
NCT ID: NCT04869579
Last Updated: 2021-08-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
PHASE2
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-08-15
Study Completion Date
2021-12-15
Brief Summary
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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.
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Detailed Description
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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.
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
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Covid19
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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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.
Group Type
EXPERIMENTAL
Selenium (as Selenious Acid)
Intervention Type
DRUG
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
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.
Group Type
ACTIVE_COMPARATOR
Placebo
Intervention Type
OTHER
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
Interventions
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Selenium (as Selenious Acid)
Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
Intervention Type
DRUG
Placebo
Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
Intervention Type
OTHER
Other Intervention Names
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Selenious Acid (AMERICAN REGENT)
Saline-based Placebo
Eligibility Criteria
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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.
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.
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.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Pharco Pharmaceuticals
INDUSTRY
Sponsor Role
collaborator
CHRISTUS Health
OTHER
Sponsor Role
lead
Responsible Party
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Mohamed Ghoweba, MD
Internal Medicine Resident Physician
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Mohamed S Ghoweba, MD
Role: PRINCIPAL_INVESTIGATOR
CHRISTUS Health
Locations
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CHRISTUS Good Shepherd Medical Center
Longview, Texas, United States
Site Status
Countries
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United States
Central Contacts
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Facility Contacts
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References
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BACKGROUND
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BACKGROUND
Other Identifiers
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2020-190
Identifier Type: -
Identifier Source: org_study_id
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NA
The Effects of Anti-oxidants on Clinical Outcomes and Radiological Features of Chronic Spinal Cord Injury: A Pilot Study
NCT01904591
COMPLETED
NA
Oxidative Stress and Nutritional Supplementation Intervention Study
NCT01234506
COMPLETED
PHASE2
Anti-inflammatory/Antioxidant Oral Nutrition Supplementation in COVID-19
NCT04323228
UNKNOWN
PHASE2/PHASE3
Effects of Water-soluble Olive Extract Supplementation
NCT01113827
COMPLETED
NA
Clinical Evaluation of the Efficacy of a Dietary Supplement Claiming Anti-aging Properties and UV-protection
NCT06571409
COMPLETED
NA
Efficacy and Tolerability of ABBC1 in Volunteers Receiving the Influenza or Covid-19 Vaccine
NCT04798677
COMPLETED
NA
The Effects of Resveratrol Supplementation on Measurements of Health and Human Performance
NCT01244360
UNKNOWN
NA
The Study of Quadruple Therapy Zinc, Quercetin, Bromelain and Vitamin C on the Clinical Outcomes of Patients Infected With COVID-19
NCT04468139
UNKNOWN
PHASE4
Trial of Nicotinamide Riboside and Co-enzyme Q10 in Chronic Kidney Disease
NCT03579693
COMPLETED
PHASE2
Investigation of the Efficacy of CARDIO Softgels PLUS Best-standard-of-care in the Recovery of Patients With COVID-19
NCT04465513
COMPLETED
NA
Trial of Glutamine and Antioxidant Supplementation in Critically Ill Patients
NCT00133978
COMPLETED
NA
Nutritional Supplement's Effects on Cognition
NCT05941949
UNKNOWN
NA
Preventive Effects of Cetylpyridinium Chloride on SarcopeniaStudy
NCT02297997
COMPLETED
EARLY_PHASE1
Study to Evaluate the Effect of Nicotinamide Riboside on Immunity
NCT02812238
COMPLETED
NA
Study to Evaluate the Effect of Nicotinamide Mononucleotide (NMN) As an Adjuvant to Standard of Care (SOC) On Fatigue Associated With COVID-19 Infection
NCT05175768
TERMINATED
NA
Fortifying Healthy Behaviors, Optimizing Medical Therapies and Enhancing Cognitive Function in Older Adults-pilot Study
NCT07000734
RECRUITING
PHASE2
Exploring the Therapeutic Effects of Creatine Supplementation for Long COVID-19
NCT06992414
NOT_YET_RECRUITING
NA