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

Study Overview
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Brief Summary
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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.

Official Title
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Modulation of the Immune Response by AM3 Glycoconjugate.

Conditions
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SARS-CoV-2 Infection

Intervention / Treatment
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* Dietary Supplement: glycophosphopeptical AM3
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AM3 supplementation group<br>2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. | Dietary Supplement: glycophosphopeptical AM3<br>* 3 g/day of AM3<br>* Other names: Inmunoferon;|
| Placebo Comparator: Control Group<br>2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. | Other: Placebo<br>* 3 g/day of placebo<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, AM3, treatment, immunomodulation