Status:
TERMINATED
Convalescent Antibodies Infusion in Critically Ill COVID 19 Patients
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Aferetica - Italy (BO)
Conditions:
Pneumonia, Ventilator-Associated
Coronavirus Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The 2019 outbreak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 or COVID 19), which originated in Wuhan, China, has become a major concern all over the world. Convalescent plasma or ...
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 consent
- Recipients
- Adult (\>18-yr-old) men and women
- COVID-19 pneumonia diagnosed by standard criteria
- Need of ventilator support
- Informed consent for participation in the study (critically ill patients will be unable to provide consent. Consent will be oral if a written consent will be impossible. If the subject is incapable of giving an informed consent and an authorized representative is not available without a delay that would, in the opinion of the Investigator, compromise the potential life-saving effect of the treatment this can be administered without consent. Consent to remain in the research should be sought as soon as the conditions of the patient will allow it).
- \<48 hours of mechanical ventilation
Exclusion
- \>48 hour mechanical ventilation
- Patient being treated with other anti-COVID-19 experimental treatments
Key Trial Info
Start Date :
April 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04346589
Start Date
April 15 2020
End Date
October 27 2022
Last Update
March 23 2023
Active Locations (5)
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1
IRFMN - Clinical Research Center for Rare Diseases
Ranica, BG, Italy, 24020
2
ASST HPG23 - Unit of Nephrology
Bergamo, Italy, 24100
3
ASST Papa Giovanni XXIII - Microbiology and Virology Unit
Bergamo, Italy, 24100
4
Asst Pg23 - S.I.M.T
Bergamo, Italy, 24100