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

NCT ID: NCT04987554

Last Updated: 2021-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-01
• Study Completion Date: 2022-12-31

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.

Conditions

SARS-CoV-2 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AM3 supplementation group

2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.

Group Type: EXPERIMENTAL

glycophosphopeptical AM3

Intervention Type: DIETARY_SUPPLEMENT

3 g/day of AM3

Control Group

2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

3 g/day of placebo

Interventions

glycophosphopeptical AM3

3 g/day of AM3

Intervention Type: DIETARY_SUPPLEMENT

Placebo

3 g/day of placebo

Intervention Type: OTHER

Other Intervention Names

Inmunoferon

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Sanidad de Castilla y León

OTHER

Sponsor Role: collaborator

University of Valladolid

OTHER

Sponsor Role: lead

Responsible Party

Diego Fernandez Lazaro

Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Salud "La Milagrosa" Soria Sur

Soria, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Diego Fernández, Professor PhD

Role: CONTACT

diego.fernandez.lazaro@uva.es

+34975129185 ext. 9185

Cesar Ignacio Fernández Lázaro, PhD

Role: CONTACT

fernandezlazaro@usal.es

+34615152130

Facility Contacts

Diego M Fernández Lázaro, PhD

Role: primary

diego.fernandez.lazaro@uva.es

658073375

Other Identifiers

2020.08.10

Identifier Type: -

Identifier Source: org_study_id