Clinical trial NCT05239988: Observational Study in COVID-19 Patients Treated With Remdesivir
Official title: National Retrospective Observational Study in Patients Treated With Remdesivir Suffering From SARS-CoV-2 Hospitalized in Internal Medicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospitalization
Keywords: COVID-19 patients
Remdesivir
Lead sponsor: Fadoi Foundation, Italy
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1004
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study includes all consecutive patients aged ≥ 18 years diagnosed with radiologically documented SARS-CoV-2 pneumonia, treated with Remdesivir (according to the criteria defined by AIFA\*) and admitted to Internal Medicine from March 2020 to August 2021.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: characteristics of COVID-19 patients
timeFrame: 2 months
measure: methods of treatment with Remdesivir and the main outcomes
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Acqui Terme
country: Italy
facility: Ospedale "Mons. Giovanni Galliano"
state: (al)
city: Acquaviva delle Fonti
country: Italy
facility: Ente Ecclesiastico "F. Miulli"
state: (ba)
city: Andria
country: Italy
facility: Ospedale di Andria
state: (bt)
city: Garbagnate Milanese
country: Italy
facility: P.O. di Garbagnate
state: (mi)
city: Melegnano
country: Italy
facility: Ospedale di Melegnano
state: (mi)
city: Stradella
country: Italy
facility: Ospedale Broni-Stradella
state: (pv)
city: Polistena
country: Italy
facility: P.O. di Polistena
state: (rc)
city: Avellino
country: Italy
facility: AO "Giuseppe Foscati"
city: Bari
country: Italy
facility: Ospedale "S. Paolo"
city: Bologna
country: Italy
facility: Ospedale di Bentivoglio
city: Bologna
country: Italy
facility: Ospedale Maggiore di Bologna Medicina D
city: Cagliari
country: Italy
facility: P.O. "SS. Trinità"
city: Cesena
country: Italy
facility: Ospedale M. Bufalini di Cesena
city: Cuneo
country: Italy
facility: Ospedale di Alba e Bra
city: Faenza
country: Italy
facility: Ospedale di Faenza
city: Firenze
country: Italy
facility: AOU Careggi
city: Firenze
country: Italy
facility: Ospedale "Careggi"
city: Frattamaggiore
country: Italy
facility: P.O di Frattamaggiore
city: Genova
country: Italy
facility: Ospedale Galliera
city: Napoli
country: Italy
facility: Ospedale del Mare
city: Novara
country: Italy
facility: Azienda Ospedaliero Universitaria di Novara
city: Perugia
country: Italy
facility: A.O.U. di Perugia
city: Rimini
country: Italy
facility: Ospedale di Rimini - Medicina 1 COVID
city: Rimini
country: Italy
facility: Ospedale di Rimini -Sub intensiva COVID
city: Roma
country: Italy
facility: Ospedale "Vannini"
city: Roma
country: Italy
facility: Ospedale Fatebenefratelli Isola Tiberina
city: Sassari
country: Italy
facility: PO SS Annunziata AOU Sassari
city: Savona
country: Italy
facility: Ospedale "San Paolo" di Savona
city: Torino
country: Italy
facility: Ospedale "Mauriziano"
city: Varese
country: Italy
facility: Ospedale "Circolo-Macchi"
Study officials:
affiliation: FADOI FOUNDATION
name: Andrea Fontanella, MD
role: STUDY_DIRECTOR
References: