Convalescent Antibodies Infusion in COVID 19 Patients
Ključne besede
Povzetek
Datumi
Nazadnje preverjeno: | 05/31/2020 |
Prvič predloženo: | 06/02/2020 |
Predviden vpis oddan: | 06/03/2020 |
Prvič objavljeno: | 06/04/2020 |
Zadnja posodobitev oddana: | 06/03/2020 |
Zadnja posodobitev objavljena: | 06/04/2020 |
Dejanski datum začetka študija: | 05/31/2020 |
Predvideni datum primarnega zaključka: | 08/31/2020 |
Predvideni datum zaključka študije: | 08/31/2020 |
Stanje ali bolezen
Intervencija / zdravljenje
Biological: Experimental antibodies (immunoglobulins) infusion
Faza
Skupine rok
Roka | Intervencija / zdravljenje |
---|---|
Experimental: Experimental antibodies (immunoglobulins) infusion Anti-coronavirus obtained with double-filtration plasmapheresis (DFPP) from convalescent patients | Biological: Experimental antibodies (immunoglobulins) infusion Antibodies obtained from consenting convalescent donors will be administered to ten consecutive patients who fulfill the inclusion criteria . |
Merila upravičenosti
Starost, primerna za študij | 18 Years Za 18 Years |
Spol, upravičen do študija | All |
Sprejema zdrave prostovoljce | Da |
Merila | Inclusion Criteria: 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 Criteria: - Need of Continuous Positive Airway Pressure (CPAP) ventilator support, Non-Invasive Ventilation (NIV) or intubation for invasive mechanical ventilation - Involvement in any clinical trial |
Izid
Primarni izidni ukrepi
1. Time to weaning of oxygen support [Through study completion, an average of 3 months]
Ukrepi sekundarnega rezultata
1. Chest XR or CT scan evaluation [Changes during the study up completion, an average of 3 months]
2. Survival, [Through study completion, an average of 3 months]
3. Viral titer [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
4. Anti COVID 19 IgG antibodies [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
5. Anti COVID 19 IgM antibodies [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
6. C5a concentration [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
7. C3a concentration [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
8. Serum C5b-9 concentration Marker of complement activation [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
9. Serum IL-6 levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
10. Serum IL-1b levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
11. Serum IFNγ levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
12. Serum MCP-1 levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
13. Serum TNFα levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
14. Serum IL-10 levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
15. Serum IL-2 levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]
16. Serum IL-7 levels [Changes from before Ig administration, one day after Ig administration and every week through study completion, an average of 3 months.]