SARS-CoV-2 InfectionNCT04987554
Glycophosphopeptical AM3 A Potential Adjuvant in the Treatment of SARS-CoV-2
A study testing glycophosphopeptical AM3 in people with SARS-CoV-2 Infection, run by University of Valladolid at 1 site in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- glycophosphopeptical AM3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
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- Patients not participating in other trials
- No hepatic and renal disorders
- Possession of mental faculties to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Centro de Salud "La Milagrosa" Soria Sur
Soria, 42003
Diego M Fernández Lázaro, PhD, 658073375, diego.fernandez.lazaro@uva.es
About this study
Official title: Modulation of the Immune Response by AM3 Glycoconjugate.
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
- Being tested
- glycophosphopeptical AM3, Placebo
- Keywords
- COVID-19, AM3, treatment, immunomodulation
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glycophosphopeptical AM3Dietary supplement
Also called Inmunoferon
3 g/day of AM3
PlaceboOther
3 g/day of placebo
| Study group | Role | What they receive |
|---|---|---|
| AM3 supplementation group | Experimental | 2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. Receives: Dietary Supplement: glycophosphopeptical AM3 |
| Control Group | Placebo comparator | 2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactato deshidrogenasa (LDH)
a catalytic enzyme found in many tissues of the body
Measured: 1day
Lactato deshidrogenasa (LDH)
a catalytic enzyme found in many tissues of the body
Measured: 30 days
Secondary outcomes (10)
Creatine kinase (CK)
CK is an enzyme expressed by various tissues and cell types.
Measured: 1day and 30 days
Myoglobin (Mb)
Mb is a muscle heteroprotein
Measured: 1day and 30 days
Aspartate Aminotransferase (AST)
markers of liver damage
Measured: 1day and 30 days
Alanine Aminotransferase (ALT)
markers of liver damage
Measured: 1day and 30 days
Interleukin 6 (IL-6)
inflammatory marker
Measured: 1day and 30 days
Interleukin 1β (IL-1β)
inflammatory marker
Measured: 1day and 30 days
tumor necrosis factor (TNF-α)
inflammatory marker
Measured: 1day and 30 days
tumor necrosis factor receptor (TNFR-α)
inflammatory marker
Measured: 1day and 30 days
C-reactive protein (CRP)
inflammatory marker; acute phase reactants.
Measured: 1day and 30 days
Ferritin (FER)
Fer is a protein that stores iron in the cells; acute phase reactants - inflammatory marker
Measured: 1day and 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start1 Apr 2021
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valladolid
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Sanidad de Castilla y León
- Responsible party
- Principal investigator, Diego Fernandez Lazaro, University of Valladolid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04987554
- Sponsor's protocol ID
- 2020.08.10
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of the Immune Response by AM3 Glycoconjugate.
- ClinicalTrials.gov ID
- NCT04987554
- Acronym / sponsor ID
- 2020.08.10
- Conditions
- SARS-CoV-2 Infection
- Keywords
- COVID-19, AM3, treatment, immunomodulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of ValladolidUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Sanidad de Castilla y León
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AM3 supplementation group | Experimental | Dietary Supplement: glycophosphopeptical AM32 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. |
| Control Group | Placebo comparator | Other: Placebo2 capsules for 30 consecutive days, distributed in a single daily oral intake in the morning on an empty stomach. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glycophosphopeptical AM3Also: Inmunoferon3 g/day of AM3 | Dietary supplement | AM3 supplementation group |
| Placebo3 g/day of placebo | Other | Control Group |
Primary outcome
Lactato deshidrogenasa (LDH)
Time frame: 1day
a catalytic enzyme found in many tissues of the body
Lactato deshidrogenasa (LDH)
Time frame: 30 days
a catalytic enzyme found in many tissues of the body
10 secondary outcomes
Creatine kinase (CK)
Time frame: 1day and 30 days
Myoglobin (Mb)
Time frame: 1day and 30 days
Aspartate Aminotransferase (AST)
Time frame: 1day and 30 days
Alanine Aminotransferase (ALT)
Time frame: 1day and 30 days
Interleukin 6 (IL-6)
Time frame: 1day and 30 days
Interleukin 1β (IL-1β)
Time frame: 1day and 30 days
tumor necrosis factor (TNF-α)
Time frame: 1day and 30 days
tumor necrosis factor receptor (TNFR-α)
Time frame: 1day and 30 days
C-reactive protein (CRP)
Time frame: 1day and 30 days
Ferritin (FER)
Time frame: 1day and 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing glycophosphopeptical AM3 in people with SARS-CoV-2 Infection, run by University of Valladolid at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego Fernández, Professor PhD (+34975129185 ext. 9185, diego.fernandez.lazaro@uva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactato deshidrogenasa (LDH) (time frame: 1day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.