Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2
Primary Purpose
SARS-CoV-2 Infection
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
glycophosphopeptical AM3
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for SARS-CoV-2 Infection focused on measuring COVID-19, AM3, treatment, immunomodulation
Eligibility Criteria
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
Sites / Locations
- Centro de Salud "La Milagrosa" Soria SurRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
AM3 supplementation group
Control Group
Arm Description
2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.
2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.
Outcomes
Primary Outcome Measures
Lactato deshidrogenasa (LDH)
a catalytic enzyme found in many tissues of the body
Lactato deshidrogenasa (LDH)
a catalytic enzyme found in many tissues of the body
Secondary Outcome Measures
Creatine kinase (CK)
CK is an enzyme expressed by various tissues and cell types.
Myoglobin (Mb)
Mb is a muscle heteroprotein
Aspartate Aminotransferase (AST)
markers of liver damage
Alanine Aminotransferase (ALT)
markers of liver damage
Interleukin 6 (IL-6)
inflammatory marker
Interleukin 1β (IL-1β)
inflammatory marker
tumor necrosis factor (TNF-α)
inflammatory marker
tumor necrosis factor receptor (TNFR-α)
inflammatory marker
C-reactive protein (CRP)
inflammatory marker; acute phase reactants.
Ferritin (FER)
Fer is a protein that stores iron in the cells; acute phase reactants - inflammatory marker
Full Information
NCT ID
NCT04987554
First Posted
July 29, 2021
Last Updated
July 29, 2021
Sponsor
University of Valladolid
Collaborators
Instituto de Salud Carlos III, Sanidad de Castilla y León
1. Study Identification
Unique Protocol Identification Number
NCT04987554
Brief Title
Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2
Official Title
Modulation of the Immune Response by AM3 Glycoconjugate.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Valladolid
Collaborators
Instituto de Salud Carlos III, Sanidad de Castilla y León
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infection
Keywords
COVID-19, AM3, treatment, immunomodulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
AM3 supplementation group
Arm Type
Experimental
Arm Description
2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.
Intervention Type
Dietary Supplement
Intervention Name(s)
glycophosphopeptical AM3
Other Intervention Name(s)
Inmunoferon
Intervention Description
3 g/day of AM3
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
3 g/day of placebo
Primary Outcome Measure Information:
Title
Lactato deshidrogenasa (LDH)
Description
a catalytic enzyme found in many tissues of the body
Time Frame
1day
Title
Lactato deshidrogenasa (LDH)
Description
a catalytic enzyme found in many tissues of the body
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Creatine kinase (CK)
Description
CK is an enzyme expressed by various tissues and cell types.
Time Frame
1day and 30 days
Title
Myoglobin (Mb)
Description
Mb is a muscle heteroprotein
Time Frame
1day and 30 days
Title
Aspartate Aminotransferase (AST)
Description
markers of liver damage
Time Frame
1day and 30 days
Title
Alanine Aminotransferase (ALT)
Description
markers of liver damage
Time Frame
1day and 30 days
Title
Interleukin 6 (IL-6)
Description
inflammatory marker
Time Frame
1day and 30 days
Title
Interleukin 1β (IL-1β)
Description
inflammatory marker
Time Frame
1day and 30 days
Title
tumor necrosis factor (TNF-α)
Description
inflammatory marker
Time Frame
1day and 30 days
Title
tumor necrosis factor receptor (TNFR-α)
Description
inflammatory marker
Time Frame
1day and 30 days
Title
C-reactive protein (CRP)
Description
inflammatory marker; acute phase reactants.
Time Frame
1day and 30 days
Title
Ferritin (FER)
Description
Fer is a protein that stores iron in the cells; acute phase reactants - inflammatory marker
Time Frame
1day and 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Diego Fernández, Professor PhD
Phone
+34975129185
Ext
9185
Email
diego.fernandez.lazaro@uva.es
First Name & Middle Initial & Last Name or Official Title & Degree
Cesar Ignacio Fernández Lázaro, PhD
Phone
+34615152130
Email
fernandezlazaro@usal.es
Facility Information:
Facility Name
Centro de Salud "La Milagrosa" Soria Sur
City
Soria
ZIP/Postal Code
42003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diego M Fernández Lázaro, PhD
Phone
658073375
Email
diego.fernandez.lazaro@uva.es
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2
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