Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2

Modulation of the Immune Response by AM3 Glycoconjugate.

Introduction: In late 2019, a novel human coronavirus was detected in Wuhan, China, causing an outbreak of the severe acute respiratory syndrome - Coronavirus 2 (SARS-CoV-2). The disease that SARS-CoV-2 causes was named coronavirus disease 2019 (COVID-19). The virus rapidly spread throughout China and beyond, causing a public health challenge of global concern. Today, the availability of safe and effective drugs to treat COVID-19 remains limited, and symptomatic supportive treatments are the foundations of care. A natural glycophosphopeptical, AM3 has been shown to effectively improve the progression of infectious respiratory diseases with no side effects. In this context, AM3 could maintain an adequate immune status and serve as a therapeutic tool against COVID-19.

Study Aim: The effect of AM3 supplementation on the progression of COVID-19 patients. To evaluate the existence of significant differences between control and intervention groups in the progression of severe COVID-19 disease.

Methods: Double-blind randomized controlled clinical trial in collaboration with the Health Care Management of Soria. At the start of the trial, eligible patients will be randomized in a 1:1 ratio into two intervention and control groups. Block randomization with participants based on gender will be used. 120 patients with a confirmed diagnosis of COVID-19 by PCR and/or antigen testing will be randomized to the control group (placebo treatment) or experimental group (AM3 treatment), respectively. Patients will be randomly divided into two groups, the AM3 supplementation group (n=60) and the control group (n=60). The intervention group will be administered 2 indistinct capsules of AM3 (3 g/day of AM3) for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. The control group will be administered a placebo of identical appearance of 2 indistinct capsules for a single daily intake in the morning, same dose as the experimental group (3 g/day of placebo), for 30 consecutive days.

Study Overview

• Status: Recruiting
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Dietary supplement: glycophosphopeptical AM3; Other: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diego Fernández, Professor PhD; Phone Number: 9185 +34975129185; Email: diego.fernandez.lazaro@uva.es
• Study Contact Backup: Name: Cesar Ignacio Fernández Lázaro, PhD; Phone Number: +34615152130; Email: fernandezlazaro@usal.es

Study Locations

• Spain
  • Soria, Spain, 42003
    • Recruiting
    • Centro de Salud "La Milagrosa" Soria Sur
    • Contact: Diego M Fernández Lázaro, PhD; Phone Number: 658073375; Email: diego.fernandez.lazaro@uva.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ≥18 years
• Males and females
• Confirmed clinical diagnosis of COVID-19 positive by Real-Time Reverse Transcription Polymerase Chain Reaction (RT-PCR) and/or SARS-CoV-2 Antigen Test performed 120 hours prior to patient inclusion in the study
• LDH 250-400 U/L
• Acceptance of informed consent signature
• IMC: 18.5-30
• Patients not participating in other trials
• No hepatic and renal disorders
• Possession of mental faculties to participate in the study

Exclusion Criteria:

• Patients with rare and specific viral diseases such as HIV
• Patients undergoing chemotherapy during the last 2 months
• Any other condition/pathology diagnosed by the medical specialist that prevents them from participating in the trial
• Intake of vitamin complexes or functional foods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AM3 supplementation group; 2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.	Dietary supplement: glycophosphopeptical AM3; 3 g/day of AM3; Other Names: Inmunoferon
PLACEBO_COMPARATOR: Control Group; 2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.	Other: Placebo; 3 g/day of placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lactato deshidrogenasa (LDH)	a catalytic enzyme found in many tissues of the body	1day
Lactato deshidrogenasa (LDH)	a catalytic enzyme found in many tissues of the body	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Creatine kinase (CK)	CK is an enzyme expressed by various tissues and cell types.	1day and 30 days
Myoglobin (Mb)	Mb is a muscle heteroprotein	1day and 30 days
Aspartate Aminotransferase (AST)	markers of liver damage	1day and 30 days
Alanine Aminotransferase (ALT)	markers of liver damage	1day and 30 days
Interleukin 6 (IL-6)	inflammatory marker	1day and 30 days
Interleukin 1β (IL-1β)	inflammatory marker	1day and 30 days
tumor necrosis factor (TNF-α)	inflammatory marker	1day and 30 days
tumor necrosis factor receptor (TNFR-α)	inflammatory marker	1day and 30 days
C-reactive protein (CRP)	inflammatory marker; acute phase reactants.	1day and 30 days
Ferritin (FER)	Fer is a protein that stores iron in the cells; acute phase reactants - inflammatory marker	1day and 30 days

Collaborators and Investigators

• Sponsor: University of Valladolid
• Collaborators: Instituto de Salud Carlos III; Sanidad de Castilla y León

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2021
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: July 29, 2021
• First Submitted That Met QC Criteria: July 29, 2021
• First Posted (ACTUAL): August 3, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 3, 2021
• Last Update Submitted That Met QC Criteria: July 29, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: treatment; COVID-19; immunomodulation; AM3
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Immunoferon
• Other Study ID Numbers: 2020.08.10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No