Efficacy and Safety of Oral Immunotherapy With GcMAF in Hospitalized Patients With COVID-19 Pneumonia

Summary

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.

Conditions

• COVID-19 Pneumonia

Interventions

DIETARY_SUPPLEMENT

Saisei Maf capsules

Dietary supplement name: Colostrum MAF, Saisei MAF immunomodulator. Formulation: 148 mg acid-resistant coated capsules, containing 2.3 mg of enzymatically treated bovine colostrum powder and supplementary ingredients The dietary supplement substances: Active ingredien: Enzymatically treated bovine colostrum powder 2.3 mg 1.6 % Supplementary ingredients: Lactase (Derived from yeast) 0,15 mg 0.1 % HPMC (Hydroxypropyl Methylcellulose) acid-resistant capsule 47 mg 31.8 % Microcrystalline cellulose (Derived from pulp) 98,4 mg 66.5 % Dosage for adults: 2 - 10 capsules daily (stronger version 9 capsules daily) Route of administration: oral Contraindication: allergy to dairy product components Precaution: pregnancy and lactation Storage: Can be stored in at + 5 to +25°C, on dry place for up to two years Manufacturer: Saisei Pharma, Osaka, MORIGUCHI city, OKUBO-cho, 3-34-8. Japan

Sponsors & Collaborators

• Dr. Spadera Lucrezia

  lead OTHER

Principal Investigators

• LUCREZIA SPADERA, MD · Department of Otorhinolaryngology Head and neck Surgery - Ospedale del Mare Hospital, naples, Italy

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-05

Primary Completion

2021-04-30

Completion

2021-06-30

Countries

• Italy

Study Locations