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

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

Sponsors

Commanditaire principal: CHRISTUS Health

Collaborateur: Pharco Pharmaceuticals

La source CHRISTUS Health
Bref résumé

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 détaillée

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.

Situation globale Not yet recruiting
Date de début 2021-08-15
Date d'achèvement 2021-12-15
Date d'achèvement principale 2021-11-15
Phase Phase 2
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
Mean change in the ordinal scale Day 1 through Day 29
Rate of hospital discharges or deaths Study duration
Résultat secondaire
Mesure Plage de temps
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
Duration of hospitalization Day 1 though Day 29
Incidence of new oxygen use Day 1 though Day 29
Duration of new oxygen use Day 1 though Day 29
Incidence of new non-invasive ventilation or high flow oxygen use Day 1 though Day 29
Duration of new non-invasive ventilation or high flow oxygen use Day 1 though Day 29
Incidence of new ventilator use Day 1 though Day 29
Duration of new ventilator use Day 1 though Day 29
Discontinuation or temporary suspension of investigational therapeutics Day 1 through Day 14
Change from baseline in alanine transaminase (ALT) Day 1 through Day 29
Change from baseline in aspartate transaminase (AST) Day 1 through Day 29
Change from baseline in creatinine (Cr) Day 1 through Day 29
Change from baseline in glucose Day 1 through Day 29
Change from baseline in hemoglobin Day 1 through Day 29
Change from baseline in platelets Day 1 through Day 29
Change from baseline in prothrombin time Day 1 through Day 29
Change from baseline in total bilirubin Day 1 through Day 29
Change from baseline in white blood cell count (WBC) with differential Day 1 through Day 29
Change from baseline in interleukin-1 (IL-1) Day 1 through Day 29
Change from baseline in interleukin-6 (IL-6) Day 1 through Day 29
Change from baseline in tumor necrosis factor alpha (TNF-α) Day 1 through Day 29
Inscription 100
État
Intervention

Type d'intervention: Drug

Nom de l'intervention: Selenium (as Selenious Acid)

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

Étiquette du groupe d'armements: Selenious Acid + Standard Of Care (SOC)

Autre nom: Selenious Acid (AMERICAN REGENT)

Type d'intervention: Other

Nom de l'intervention: Placebo

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

Étiquette du groupe d'armements: Standard Of Care (SOC) + Placebo

Autre nom: Saline-based Placebo

Admissibilité

Critères:

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.

Le sexe:

All

Âge minimum:

18 Years

Âge maximum:

N/A

Volontaires en santé:

No

Officiel général
Nom de famille Rôle Affiliation
Mohamed S Ghoweba, MD Principal Investigator CHRISTUS Health
Contact général

Nom de famille: Mohamed S Ghoweba, MD

Téléphone: 318-219-6701

Email: [email protected]

Emplacement
Établissement: Contact: CHRISTUS Good Shepherd Medical Center Mohamed Ghoweba, MD 318-219-6701 [email protected]
Pays d'implantation

United States

Date de vérification

2021-07-01

Partie responsable

Type: Principal Investigator

Affiliation des enquêteurs: CHRISTUS Health

Nom complet de l'enquêteur: Mohamed Ghoweba, MD

Titre d'enquêteur: Internal Medicine Resident Physician

Mots clés
A un accès étendu No
Parcourir l'état
Nombre d'armes 2
Groupe d'armes

Étiquette: Selenious Acid + Standard Of Care (SOC)

Type: Experimental

La description: 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.

Étiquette: Standard Of Care (SOC) + Placebo

Type: Active Comparator

La description: 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.

Acronyme SeCOVID
Données patient Yes
Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Description du modèle d'intervention: 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.

Objectif principal: Treatment

Masquage: Double (Participant, Investigator)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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