2.1. Ethics and Study Design
MAY, COVID-19 INFECTION
The lactoferrin for treatment of acute COVID-19 in hospitalized patients trial (LAC trial) is a non-profit, randomized, double-blind, multicenter, placebo-controlled, parallel-arm clinical trial (ClincalTrials.gov registration: NCT04847791). This study was approved by the Local Ethics Committee (Comitato Etico Interaziendale Novara, Identifier: CE 6/21) and conducted in accordance with the Declaration of Helsinki. The study took place from January to May 2021, during the third wave of the COVID-19 pandemic in Italy. The aim of this study was to evaluate the efficacy of an oral daily dose of bovine lactoferrin vs. placebo in limiting the progression and severity of COVID-19 infection and/or favoring clinical recovery in hospitalized patients. Lactoferrin therapy was administered in combination with standard COVID-19 therapy. This report follows the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines (