Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2
Modulation of the Immune Response by AM3 Glycoconjugate.
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2021
CompletedFirst Submitted
Initial submission to the registry
July 29, 2021
CompletedFirst Posted
Study publicly available on registry
August 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedAugust 3, 2021
July 1, 2021
9 months
July 29, 2021
July 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (10)
Creatine kinase (CK)
1day and 30 days
Myoglobin (Mb)
1day and 30 days
Aspartate Aminotransferase (AST)
1day and 30 days
Alanine Aminotransferase (ALT)
1day and 30 days
Interleukin 6 (IL-6)
1day and 30 days
- +5 more secondary outcomes
Study Arms (2)
AM3 supplementation group
EXPERIMENTAL2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.
Control Group
PLACEBO COMPARATOR2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.
Interventions
3 g/day of AM3
Eligibility Criteria
You may qualify if:
- ≥18 years
- Males and females
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Valladolidlead
- Instituto de Salud Carlos IIIcollaborator
- Sanidad de Castilla y Leóncollaborator
Study Sites (1)
Centro de Salud "La Milagrosa" Soria Sur
Soria, 42003, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor Doctor
Study Record Dates
First Submitted
July 29, 2021
First Posted
August 3, 2021
Study Start
April 1, 2021
Primary Completion
December 31, 2021
Study Completion
December 31, 2022
Last Updated
August 3, 2021
Record last verified: 2021-07