"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".

ABSTRACT:

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. I

SUBMITTER: Teofili L 

PROVIDER: S-EPMC7578576 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature