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

NCT04869579 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 2020-190
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19

Keywords

COVID-19 Pneumonia; Cytokine Storm; ARDS; Moderate COVID-19 Infections; Severe COVID-19 Infections; Critical COVID-19 Infections; Selenium

Outcome Measures

Primary Outcomes (2)

• 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

• Rate of hospital discharges or deaths

  Rate of patient discharge to home or other long-term care facilities, or death.

  Study duration

Secondary Outcomes (25)

• Clinical status using ordinal scale

  Day 1 through Day 29

• Mean change in the ordinal scale

  Day 1 though Day 29

• Time to an improvement of one category using an ordinal scale

  Day 1 though Day 29

• Change in National Early Warning Score (NEWS) from baseline

  Day 1 through Day 29

• Cumulative incidence of serious adverse events (SAEs)

  Day 1 through Day 29

Study Arms (2)

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.

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.

Other: Placebo

Interventions

Selenium (as Selenious Acid) DRUG

Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.

Also known as: Selenious Acid (AMERICAN REGENT)

Selenious Acid + Standard Of Care (SOC)

Placebo OTHER

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

Also known as: Saline-based Placebo

Standard Of Care (SOC) + Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CHRISTUS Health: lead
• Pharco Pharmaceuticals: collaborator

Study Sites (1)

CHRISTUS Good Shepherd Medical Center

Longview, Texas, 75601, United States

Location

Related Publications (58)

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MeSH Terms

Conditions

COVID-19; Cytokine Release Syndrome

Interventions

Selenious Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Selenium Compounds; Inorganic Chemicals

Study Officials

• Mohamed S Ghoweba, MD

  CHRISTUS Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed S Ghoweba, MD

CONTACT

318-219-6701; mohamed.ghoweba@christushealth.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Internal Medicine Resident Physician

Model Details: 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.

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 3, 2021
• Study Start: August 15, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 15, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Researchers who provide a methodologically sound proposal.

Locations

US (1)