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The trend of the spread of the COVID-19 pandemic demonstrates in Lombardy, starting from 28.03.2020, a slowdown in the exponential phase of infections and the probable reaching of a plateau phase.
However, a marked increase in infections was observed in the so-called "protected structures" such as nursing homes (RSA), both in health staff and in the residents of such facilities. The observed percentage of lethality, according to the more recent data provided by the National Institute of Health, is very high especially among residents.
For these reasons, the city Hospital (ASST) of Mantua , already involved in the use of hyperimmune plasma as a therapy for COVID-19, designed this study in order to evaluate RSA patients and to identify the cases eligible for this treatment.
For a detailed description of the study, see the attached protocol
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| convalescent plasma | Experimental | Cohort of elderly patients treated with convalescent plasma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Convalescent plasma | Biological | COVID-19 elderly patients treated with convalescent plasma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Death | Death from any cause | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Viral load | Naso-pharyngeal swab | 7 days |
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Inclusion Criteria:
Elderly patients (> 65 years old) with SARS-CoV-2 RT-PCR positivity on nasal swab or score higher than 5 with the following characteristics:
Patients who have signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Massimo Franchini | ASST Mantova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Transfusion Service | Mantua | 46100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33585799 | Derived | Franchini M, Glingani C, Morandi M, Corghi G, Cerzosimo S, Beduzzi G, Storti A, Di Stasi V, Rastrelli G, Vignozzi L, Mengoli C, Garuti M, Beccaria M, Inglese F, Caruso B, Petilino RA, Amato M, Nicchio M, Pagani M, Bellani A, Castelli G, Casari S, De Donno G. Safety and Efficacy of Convalescent Plasma in Elderly COVID-19 Patients: The RESCUE Trial. Mayo Clin Proc Innov Qual Outcomes. 2021 Apr;5(2):403-412. doi: 10.1016/j.mayocpiqo.2021.01.010. Epub 2021 Feb 8. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 15, 2020 | Sep 30, 2020 | Prot_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |