Status:
WITHDRAWN
Convalescent Antibodies Infusion in COVID 19 Patients
Lead Sponsor:
Piero Luigi Ruggenenti
Collaborating Sponsors:
Aferetica
Conditions:
Pneumonia, Viral
Corona Virus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or immunoglobulins h...
Eligibility Criteria
Inclusion
- Plasma Ig Donors
- Adult (\>18 and \<65-yr-old) men and women
- Convalescent donor who recovered from COVID 19 from at least 14 days according to the clinical and laboratory criteria defined by the Consiglio Superiore di Sanità on February 20, 2019 ("The recovered patient is the one who resolves the symptoms of COVID-19 infection and who is negative in two consecutive tests for the search for SARS-Cov-2, performed 24 hours apart") with the exceptions mentioned in the attached derogation (that is "no upper age limit to donation provided there are no clinical contraindications to the procedure and independent of documented evidence of two negative tests for SARS-Cov 2 naso-faringeal contamination")
- Male or female donor; if female only if nulliparous; in both cases with a negative history of blood component transfusions
- Careful clinical evaluation of the patient-donor with particular reference to the criteria established by current legislation to protect the health of the donor who donates by apheresis
- Presence of adequate levels of neutralizing anti-SARS-COV-2 antibodies;
- Biological qualification test negative defined by current indications (performed at SIMT of HPG23)
- Test negative for: HAV RNA, HEV RNA, PVB19 DNA (performed at HPG23)
- Informed written consent
- Recipients
- \>18 years of age
- COVID-19 pneumonia diagnosed by standard criteria (viral detection in naso-faringeal or bronco-alveolar lavage by RT-PCR for SARS-COV-2, typical Chest X Ray or CT Scan, ventilatory dysfunction not directly explained by heart failure or fluid overload)
- Respiratory failure (i.e. room air PaO2\<60 mmHg) needing oxygen support with Venturi mask (FiO2 between 28 and 60%), non-rebreathing mask or high flow-nasal cannula (HFNC);
- Patient written informed consent
Exclusion
- Need of Continuous Positive Airway Pressure (CPAP) ventilator support, Non-Invasive Ventilation (NIV) or intubation for invasive mechanical ventilation
- Involvement in any clinical trial
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 21 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04418531
Start Date
June 1 2020
End Date
September 21 2022
Last Update
September 23 2022
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