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NCT04845971COMPLETEDanonymous

Phase II Clinical Trial Evaluating Efficacy and Safety of Oral Immunotherapy With Third Generation Gc Protein Derived Macrophage Activating Factor (GcMAF) in Hospitalized Patients With COVID-19 Pneumonia: the COral-MAF1 Trial

Sponsor

Source record

Dr. Spadera Lucrezia

Phase

Source record

PHASE2

Modality

AI-normalized

cell therapy

Target

AI-normalized

Saisei Maf capsules

Indication / condition

AI-normalized

COVID-19 Pneumonia

Intervention

Source record

Saisei Maf capsules

Source & freshness

Source record

NCT ID

NCT04845971

Original source

ClinicalTrials.gov

Source last updated

Sep 08, 2021

Ingested at

Jun 19, 2026

Internal sync

Jun 19, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT04845971

Title

Phase II Clinical Trial Evaluating Efficacy and Safety of Oral Immunotherapy With Third Generation Gc Protein Derived Macrophage Activating Factor (GcMAF) in Hospitalized Patients With COVID-19 Pneumonia: the COral-MAF1 Trial

Sponsor

Dr. Spadera Lucrezia

Status

COMPLETED

Phase

PHASE2

Condition raw

COVID-19 Pneumonia

Condition normalized

COVID-19 Pneumonia

Modality raw

cell therapy

Modality normalized

cell therapy

Target raw

Saisei Maf capsules

Target normalized

Saisei Maf capsules

Interventions

Saisei Maf capsules

Public preview

Source record

As of August 16, 2020, the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has been responsible for more than 21 294 000 infections and about 760 000 deaths worldwide. Accumulating evidence suggests that patients with severe acute COVID-19 pneumonia have a cytokine storm syndrome, or unbalanced hyper-inflammatory response. It is now well known that GcMAF plays a crucial role in immune system regulation as a primary defense against infections. Thus, this multifunctional protein, released into the blood stream, acts as a systemic immune modulator without pro-inflammatory activities. In an animal study, IL-6 level was shown to be dramatically decreased after 21 days of oral administration colostrum MAF. Indeed, data from previous studies and clinical practice have been reported its effectiveness and safety in the treatment of many pathologies such as infectious diseases, some types of cancer, juvenile osteopetrosis, immunological, and neurological diseases. These observations suggest that oral immunotherapy with colostrum-MAF is potentially an effective and well-tolerated treatment for COVID-19 pneumonia. In addition, gastrointestinal involvement is well known in coronavirus infections of animals and humans. The angiotensin-converting enzyme II (ACE2), the entry receptor for SARS-CoV, is highly expressed in proximal and distal enterocytes that are directly exposed to foreign pathogens. It considers the mechanism of SARS-CoV-2 can actively infect and replicate in the gastrointestinal tract. SARS-CoV-2 indirectly damages the digestive system through a chain of inflammatory responses. Delivered topically to the small intestine by an acid-resistant enteric-coated capsule colostrum MAF can directly activate a large number of gut mucosal macrophages for virus control, localizing intestinal inflammation and resolving through driven phagocytic scavenger function. Macrophages in the gastrointestinal mucosa represent the largest pool of tissue macrophages in the body, which besides the local functions are directing the systemic immune response.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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