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

SARS-CoV-2 Infection Clinical Trial

Official title:

Modulation of the Immune Response by AM3 Glycoconjugate.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04987554
• Other study ID #: 2020.08.10
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: University of Valladolid
• Contact: Diego Fernández, Professor PhD
• Phone: +34975129185
• Email: diego.fernandez.lazaro[@]uva.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• SARS-CoV-2 Infection

Intervention

Dietary Supplement:
• glycophosphopeptical AM3
3 g/day of AM3

Other:
• Placebo
3 g/day of placebo

Locations

Country	Name	City	State
Spain	Centro de Salud "La Milagrosa" Soria Sur	Soria

Sponsors (3)

Lead Sponsor	Collaborator
University of Valladolid	Instituto de Salud Carlos III, Sanidad de Castilla y León

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lactato deshidrogenasa (LDH)	a catalytic enzyme found in many tissues of the body	1day
Primary	Lactato deshidrogenasa (LDH)	a catalytic enzyme found in many tissues of the body	30 days
Secondary	Creatine kinase (CK)	CK is an enzyme expressed by various tissues and cell types.	1day and 30 days
Secondary	Myoglobin (Mb)	Mb is a muscle heteroprotein	1day and 30 days
Secondary	Aspartate Aminotransferase (AST)	markers of liver damage	1day and 30 days
Secondary	Alanine Aminotransferase (ALT)	markers of liver damage	1day and 30 days
Secondary	Interleukin 6 (IL-6)	inflammatory marker	1day and 30 days
Secondary	Interleukin 1ß (IL-1ß)	inflammatory marker	1day and 30 days
Secondary	tumor necrosis factor (TNF-a)	inflammatory marker	1day and 30 days
Secondary	tumor necrosis factor receptor (TNFR-a)	inflammatory marker	1day and 30 days
Secondary	C-reactive protein (CRP)	inflammatory marker; acute phase reactants.	1day and 30 days
Secondary	Ferritin (FER)	Fer is a protein that stores iron in the cells; acute phase reactants - inflammatory marker	1day and 30 days