Status:
COMPLETED
Efficacy and Safety of Oral Immunotherapy With GcMAF in Hospitalized Patients With COVID-19 Pneumonia
Lead Sponsor:
Dr. Spadera Lucrezia
Conditions:
COVID-19 Pneumonia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 eviden...
Detailed Description
Over the last five months, there have been increasing numbers of reports that struggle to understand the pathogenesis of the coronavirus disease 2019 (COVID-19) pandemic. To date, the most commonly in...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2021
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT04845971
Start Date
November 5 2020
End Date
June 30 2021
Last Update
September 8 2021
Active Locations (1)
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1
Ospedale del Mare Hospital
Naples, Italy, 80131