Efficacy and Safety of Ovotransferrin in COVID-19 Patients

NCT04643054 | Unknown

• 1 other identifier: 20201116
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Chicken egg consists of three main components, egg white (56%), yolk (33%) and shell (11%). The key component of egg white is 88 percent water and 12 percent solids, of which over 90 percent are protein. Ovalbumin, ovotransferrin, and ovomucoid are considered the main proteins, while ovomucin, lysozyme, ovoglobulin, ovomacroglobulin, ovoglycoprotein, ovoflavoprotein, thiamin-binding proteins, ficin/papain inhibitors, avidin, and cystatin are the minor white proteins of the embryo. These proteins and their peptides have been recognized as antioxidants, antimicrobials, metal-chelators, anti-viral, anti-tumor, and angiotensin-converting enzyme (ACE)-inhibitors for their functional significance SARS-CoV-2 virus activates the human cell ACE2 receptor, triggering a series of deleterious events. In COVID19, renin-angiotensin is upregulated and the pathway is overexpressed and a progressive cytokine storm is always observed. In all these pathogenic processes, ovotransferrin could play a modifier function to enhance the condition. Ovotransferrin can be beneficial to the antioxidant effects of Angiotensin II by inhibiting NF-kB. Ovotransferrin is an immunomodulator that downregulates pro-inflammatory cytokines including TNF-α, IL-6, and IL-1 that could extinguish the cytokine storm. Ovotransferrin can also serve as a protective agent against COVID19 cardiotoxicity due to disruption in the ACE2-mediated signaling pathway, cytokine storm, pulmonary dysfunction, and side effects of medications. In patients with coronavirus infection, provided ovotransferrin's possible protective effects, it is suggested as a supportive and therapeutic alternative. Given this background, in the light of the current COVID-19 emergency, it is the intention of the investigators to conduct a prospective, randomized, open-label, controlled study in the cohort of hospitalized patients with covid-19 pneumonia, administering 200 mg of ovotransferrin orally in addition to the standard of care therapy (SOC). The investigators hypothesize that the use of ovotransferrin will be associated with an earlier improvement of clinical and humoral parameters after 10 days of ovotransferrin treatment when compared to the group of patients provided with standard care.

Conditions

Covid19

Keywords

Ovotransferrin

Outcome Measures

Primary Outcomes (1)

• In-hospital mortality

  Change of hospital mortality

  48hours

Secondary Outcomes (5)

• C reactive protein (CRP) levels

  48 hours

• IL-6 levels

  48 hours

• D-dimer levels

  48 hours

• Hospital stay

  up to 24 weeks

• Duration of positive PCR swab

  5 days

Study Arms (2)

Ovotransferrin

EXPERIMENTAL

Dietary Supplement: Ovotransferrin

Dietary Supplement: Ovotransferrin

Standard of care

NO INTERVENTION

Standard of care

Interventions

Ovotransferrin DIETARY_SUPPLEMENT

Administering 200 mg of ovotransferrin orally in addition to the standard of care therapy for 10 days

Ovotransferrin

Eligibility Criteria

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

You may qualify if:

• Positive swab test of SARS-CoV-2
• Pneumonia related to SARS-CoV-2
• Signature of informed consent
• Absence of allergies to egg proteins

You may not qualify if:

• Unsigned informed consent
• Negative swab test of SARS-CoV-2
• Allergy to egg proteins
• Pregnancy and breastfeeding
• Mechanical ventilation

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo: lead

Study Sites (1)

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone

Palermo, 90127, Italy

Location

Related Publications (4)

• Abeyrathne EDNS, Huang X, Ahn DU. Antioxidant, angiotensin-converting enzyme inhibitory activity and other functional properties of egg white proteins and their derived peptides - A review. Poult Sci. 2018 Apr 1;97(4):1462-1468. doi: 10.3382/ps/pex399.

  PMID: 29340654 BACKGROUND

• Benede S, Molina E. Chicken Egg Proteins and Derived Peptides with Antioxidant Properties. Foods. 2020 Jun 3;9(6):735. doi: 10.3390/foods9060735.

  PMID: 32503187 BACKGROUND

• Chen S, Jiang H, Peng H, Wu X, Fang J. The Utility of Ovotransferrin and Ovotransferrin-Derived Peptides as Possible Candidates in the Clinical Treatment of Cardiovascular Diseases. Oxid Med Cell Longev. 2017;2017:6504518. doi: 10.1155/2017/6504518. Epub 2017 Mar 13.

  PMID: 28386310 BACKGROUND

• Giansanti F, Massucci MT, Giardi MF, Nozza F, Pulsinelli E, Nicolini C, Botti D, Antonini G. Antiviral activity of ovotransferrin derived peptides. Biochem Biophys Res Commun. 2005 May 27;331(1):69-73. doi: 10.1016/j.bbrc.2005.03.125.

  PMID: 15845359 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Conalbumin

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

Intervention Hierarchy (Ancestors)

Albumins; Proteins; Amino Acids, Peptides, and Proteins; Transferrins; Iron-Binding Proteins; Carrier Proteins; Egg Proteins, Dietary; Animal Proteins, Dietary; Dietary Proteins; Egg Proteins; Metalloproteins

Study Officials

• Antonio Cascio, MD, PhD

  AOU Policlinico "P. Giaccone" - University of Palermo, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Cascio, MD, PhD

CONTACT

+393389912198; antonio.cascio03@unipa.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Infectious and Tropical Diseases Departmemt

Study Record Dates

• First Submitted: November 22, 2020
• First Posted: November 24, 2020
• Study Start: December 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: March 30, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)