Observational Study in COVID-19 Patients Treated With Remdesivir

NCT ID: NCT05239988

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1004 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-24

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hospitalization

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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COVID-19 patients treated with Remdesivir

Patients suffering from SARS-CoV-2 and treated with Remdesivir admitted to Internal Medicine Unit

no experimental intervention

Intervention Type OTHER

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

Interventions

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no experimental intervention

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fadoi Foundation, Italy

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrea Fontanella, MD

Role: STUDY_DIRECTOR

FADOI FOUNDATION

Locations

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Ospedale "Mons. Giovanni Galliano"

Acqui Terme, (AL), Italy

Site Status

Ente Ecclesiastico "F. Miulli"

Acquaviva delle Fonti, (BA), Italy

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Ospedale di Andria

Andria, (BT), Italy

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P.O. di Garbagnate

Garbagnate Milanese, (MI), Italy

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Ospedale di Melegnano

Melegnano, (MI), Italy

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Ospedale Broni-Stradella

Stradella, (PV), Italy

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P.O. di Polistena

Polistena, (RC), Italy

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AO "Giuseppe Foscati"

Avellino, , Italy

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Ospedale "S. Paolo"

Bari, , Italy

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Ospedale di Bentivoglio

Bologna, , Italy

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Ospedale Maggiore di Bologna Medicina D

Bologna, , Italy

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P.O. "SS. Trinità"

Cagliari, , Italy

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Ospedale M. Bufalini di Cesena

Cesena, , Italy

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Ospedale di Alba e Bra

Cuneo, , Italy

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Ospedale di Faenza

Faenza, , Italy

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AOU Careggi

Florence, , Italy

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Ospedale "Careggi"

Florence, , Italy

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P.O di Frattamaggiore

Frattamaggiore, , Italy

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Ospedale Galliera

Genova, , Italy

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Ospedale del Mare

Napoli, , Italy

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Azienda Ospedaliero Universitaria di Novara

Novara, , Italy

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A.O.U. di Perugia

Perugia, , Italy

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Ospedale di Rimini - Medicina 1 COVID

Rimini, , Italy

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Ospedale di Rimini -Sub intensiva COVID

Rimini, , Italy

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Ospedale "Vannini"

Roma, , Italy

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Ospedale Fatebenefratelli Isola Tiberina

Roma, , Italy

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PO SS Annunziata AOU Sassari

Sassari, , Italy

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Ospedale "San Paolo" di Savona

Savona, , Italy

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Ospedale "Mauriziano"

Torino, , Italy

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Ospedale "Circolo-Macchi"

Varese, , Italy

Site Status

Countries

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Italy

Other Identifiers

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FADOI.02.2021

Identifier Type: -

Identifier Source: org_study_id

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