Observational Study in COVID-19 Patients Treated With Remdesivir

Fadoi Foundation, Italy1,004 enrolled

Overview

Taking into account the high number of COVID-19 patients managed in Italian Internal Medicine, Fadoi Foundation (Italian Scientific Society of Internal Medicine) promotes a national retrospective observational study in patients treated with Remdesivir, analyzing the characteristics of patients and their clinical outcome during hospitalization, and thus providing real-life information potentially useful to integrate the evidence produced by studies conducted under experimental conditions and available in the literature.

This is a multicenter observational, retrospective study, which involves the participation of 35 Nationally Representative Internal Medicine Units, for each center data on all patients suffering from SARS-CoV-2 and treated with Remdesivir are expected to be recorded. Each center will have the task of collecting the data of patients hospitalized consecutively proceeding backwards until March 2020. The study is a no-profit scientific project, promoted by The FADOI Foundation, the Scientific Society of Internal Medicine.

Study Type

OBSERVATIONAL

Enrollment

1,004

Conditions

Hospitalization

Interventions

no experimental interventionOTHER

There will not be any experimental intervention. The study will be conducted according with normal clinical practice

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * patients aged ≥ 18 years * diagnosed with radiologically documented SARS-CoV-2 pneumonia * treated with Remdesivir (according to the criteria defined by AIFA\*) * admitted to Internal Medicine from March 2020 to August 2021. Exclusion Criteria: * none

Locations (30)

Ospedale "Mons. Giovanni Galliano"

Acqui Terme, (AL), Italy

Outcomes

Primary Outcomes

characteristics of COVID-19 patients

describe, under conditions of normal clinical practice ("real-life") the different clinical characteristics of patients suffering from SARS-CoV-2, hospitalized in Internal Medicine and treated with Remdesivir

Time frame: 2 months

methods of treatment with Remdesivir and the main outcomes

evaluate the methods of treatment with Remdesivir (initiation of therapy with respect to the onset of symptoms) and the main outcomes (duration of hospitalization, possible clinical worsening, side effects, transfer to Intensive Care, mortality).

Time frame: 2 months

Data from ClinicalTrials.gov

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