| Title: |
“Early transfusion of convalescent plasma in older patients with COVID-19 to prevent disease progression: A structured summary of a study protocol for a randomised controlled trial” |
| Authors: |
Luciana Teofili; Raffaele Landolfi; Antonella Cingolani; Andrea Antinori; Jacopo Vecchiet; Maurizio Sanguinetti; Antonio Gasbarrini; Tina Pasciuto; Nicoletta Orlando; Silvia Lamonica |
| Source: |
Trials, Vol 21, Iss 1, Pp 1-2 (2020) |
| Publisher Information: |
BMC |
| Publication Year: |
2020 |
| Collection: |
Directory of Open Access Journals: DOAJ Articles |
| Subject Terms: |
COVID-19; randomised controlled trial; protocol; elderly; comorbidities; Medicine (General); R5-920 |
| Description: |
Objectives The primary objective is to demonstrate that COVID-19 convalescent plasma (CCP) prevents progression to severe pneumonia in elderly COVID-19 pneumonia patients with chronic comorbidities. Secondary objectives are to demonstrate that CCP decreases the viral load in nasopharyngeal swabs and increases the anti-SARS-CoV-2 antibody titre in recipients. Trial design This is a randomized, open-label, parallel group, phase II/III study with a superiority framework. The trial starts with a screening phase II designed with two-tailed alpha=0.2. In case of positive results, the trial will proceed in a formally comparative phase III (alpha=0.05). Participants Adult patients with confirmed or suspected COVID-19 who are at risk according to CDC definition are eligible. Inclusion criteria are all the following: age ≥ 65; pneumonia at CT scan; PaO2/FiO2 ≥300 mmHg; presence of one or more comorbidities; signed informed consent. Exclusion criteria are one of the following: age < 65; PaO2/FiO2 < 300 mmHg; pending cardiopulmonary arrest; refusal to blood product transfusions; severe IgA deficiency; any life-threatening comorbidity or any other medical condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion. The trial is being conducted at three reference COVID-19 centres in the middle of Italy. Intervention and comparator Intervention: COVID-19 Convalescent Plasma (CCP) in addition to standard therapy. Patients receive three doses (200 ml/day on 3 consecutive days) of ABO matched CCP. Comparator: Standard therapy Main outcomes A. Primary outcome for Phase II: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. B. Primary outcome for Phase III: Proportion of patients without progression in severity of pulmonary disease, defined as worsening of 2 points in the ordinal scale of WHO by day 14. Secondary outcomes for Phase III: Decreased viral load on nasopharyngeal swab at ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
http://link.springer.com/article/10.1186/s13063-020-04821-1; https://doaj.org/toc/1745-6215; https://doaj.org/article/dd206d4cb97e45308cdada246ea70967 |
| DOI: |
10.1186/s13063-020-04821-1 |
| Availability: |
https://doi.org/10.1186/s13063-020-04821-1; https://doaj.org/article/dd206d4cb97e45308cdada246ea70967 |
| Accession Number: |
edsbas.F30971ED |
| Database: |
BASE |