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NCT05239988 Clinical Trial

Observational Study in COVID-19 Patients Treated With Remdesivir

Hospitalization Clinical Trial

— RECOVER  

Official title:
National Retrospective Observational Study in Patients Treated With Remdesivir Suffering From SARS-CoV-2 Hospitalized in Internal Medicine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05239988
Other study ID # FADOI.02.2021
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 24, 2021
Est. completion date June 30, 2022

Study information
Verified date February 2024
Source Fadoi Foundation, Italy
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 1004
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no experimental intervention
There will not be any experimental intervention. The study will be conducted according with normal clinical practice

Locations
Country Name City State
Italy Ente Ecclesiastico "F. Miulli" Acquaviva delle Fonti (ba)
Italy Ospedale "Mons. Giovanni Galliano" Acqui Terme (al)
Italy Ospedale di Andria Andria (bt)
Italy AO "Giuseppe Foscati" Avellino
Italy Ospedale "S. Paolo" Bari
Italy Ospedale di Bentivoglio Bologna
Italy Ospedale Maggiore di Bologna Medicina D Bologna
Italy P.O. "SS. Trinità" Cagliari
Italy Ospedale M. Bufalini di Cesena Cesena
Italy Ospedale di Alba e Bra Cuneo
Italy Ospedale di Faenza Faenza
Italy AOU Careggi Firenze
Italy Ospedale "Careggi" Firenze
Italy P.O di Frattamaggiore Frattamaggiore
Italy P.O. di Garbagnate Garbagnate Milanese (mi)
Italy Ospedale Galliera Genova
Italy Ospedale di Melegnano Melegnano (mi)
Italy Ospedale del Mare Napoli
Italy Azienda Ospedaliero Universitaria di Novara Novara
Italy A.O.U. di Perugia Perugia
Italy P.O. di Polistena Polistena (rc)
Italy Ospedale di Rimini - Medicina 1 COVID Rimini
Italy Ospedale di Rimini -Sub intensiva COVID Rimini
Italy Ospedale "Vannini" Roma
Italy Ospedale Fatebenefratelli Isola Tiberina Roma
Italy PO SS Annunziata AOU Sassari Sassari
Italy Ospedale "San Paolo" di Savona Savona
Italy Ospedale Broni-Stradella Stradella (pv)
Italy Ospedale "Mauriziano" Torino
Italy Ospedale "Circolo-Macchi" Varese

Sponsors (1)
Lead Sponsor Collaborator
Fadoi Foundation, Italy

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 months
Primary 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). 2 months
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