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

NCT04845971 | Completed Phase 2 DMC

• 1 other identifier: COral-MAF1 Trial - Version 1.0
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

COVID-19; VDBP; GcMAF; colostrum-MAF; oral; food supplement

Outcome Measures

Primary Outcomes (1)

• the rate of transfer to the intensive care unit (ICU)

  the proportion of hospitalized patients requiring intensive care management because of worsening respiratory function (PaO2/FiO2 ratio \<150 mmHg) and/or development of multi-organ dysfunction and/or other clinical conditions needing invasive mechanical ventilation Given that 26% of patients required intensive care unit treatment, the purpose of this trial is to achieve a reduction of at least 50% of this value with an overall rate of transfer to the ICU of 13%.

  28 days or until discharge

Secondary Outcomes (26)

• Changes from baseline to subsequent timepoints (when available) in terms of percentage of lung involvement (lung consolidation, ground glass opacities and disease free).

  28 days or until discharge

• duration of hospital stay

  28 days or until discharge

• days on non-invasive ventilation

  28 days or until discharge

• time to reduction of FiO2 > 25%

  28 days or until discharge

• days with use of supplemental O2

  28 days or until discharge

Study Arms (1)

Adult male and female patients who are hospitalized with COVID-19-induced pneumonia.

EXPERIMENTAL

Eligible patients will be treated with Saisei MAF capsules stronger version, oral administration 2-3 capsules, 3 times per day, 30 minutes before food or in the morning, afternoon and before bed time. The treatment duration will be 21 days. Patients are also provided with nutritional supplementation of Vitamin D3, 10.000 IU per day, monitoring the blood levels of such a vitamin. Efficacy and safety assessments will be performed on Days 0, 7, 14, 21, and 28.

Dietary Supplement: Saisei Maf capsules

Interventions

Saisei Maf capsules DIETARY_SUPPLEMENT

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

Also known as: Colostrum MAF, Oral MAF, GcMAF

Adult male and female patients who are hospitalized with COVID-19-induced pneumonia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (≥ 18 years of age);
• signed informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative or according to local guidelines;
• patients clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology;
• hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan with pulmonary infiltrates;
• patients having a PAO2/FIO2 ratio \> 250 mmHg;
• well-selected patients having a PAO2/FIO2 ratio ≤ 250 mmHg that, in the investigator's judgment, doesn't preclude the patient's safe participation in and completion of the study;
• patients being able to swallow.

You may not qualify if:

• Proportion of hospitalized patients requiring invasive mechanical ventilation at the time of hospital admission (patients requiring non-invasive mechanical ventilation are eligible);
• uncontrolled systemic infection (other than COVID-19);
• hypersensitivity to the active substance or to any of the excipients of the experimental drug, including known allergy to dairy product;
• any serious medical condition or abnormality of clinical laboratory tests;
• in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours, irrespective of the provision of treatments;
• current participation in any other interventional investigational trials;
• pregnant or breastfeeding woman;
• concurrent malignancy requiring chemotherapy;
• renal insufficiency;
• all types of disability.

Sponsors & Collaborators

• Dr. Spadera Lucrezia: lead

Study Sites (1)

Ospedale del Mare Hospital

Naples, 80131, Italy

Location

MeSH Terms

Conditions

COVID-19

Interventions

vitamin D-binding protein-macrophage activating factor

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• LUCREZIA SPADERA, MD

  Department of Otorhinolaryngology Head and neck Surgery - Ospedale del Mare Hospital, naples, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor - Department of Otorhinolaryngology Head and Neck Surgery

Model Details: we reserve the possibility that the study may become parallel

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: April 15, 2021
• Study Start: November 5, 2020
• Primary Completion: April 30, 2021
• Study Completion: June 30, 2021
• Last Updated: September 8, 2021

Record last verified: 2021-04

Locations

IT (1)