Observational Study in COVID-19 Patients Treated With Remdesivir
- Conditions
- Hospitalization
- Interventions
- Other: no experimental intervention
- Registration Number
- NCT05239988
- Lead Sponsor
- Fadoi Foundation, Italy
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1004
- 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.
- none
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 patients treated with Remdesivir no experimental intervention Patients suffering from SARS-CoV-2 and treated with Remdesivir admitted to Internal Medicine Unit
- Primary Outcome Measures
Name Time Method characteristics of COVID-19 patients 2 months 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
methods of treatment with Remdesivir and the main outcomes 2 months 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (30)
Ospedale Galliera
🇮🇹Genova, Italy
Ospedale "Mons. Giovanni Galliano"
🇮🇹Acqui Terme, (al), Italy
Ospedale di Melegnano
🇮🇹Melegnano, (mi), Italy
Ente Ecclesiastico "F. Miulli"
🇮🇹Acquaviva delle Fonti, (ba), Italy
Ospedale di Andria
🇮🇹Andria, (bt), Italy
P.O. di Garbagnate
🇮🇹Garbagnate Milanese, (mi), Italy
Ospedale Broni-Stradella
🇮🇹Stradella, (pv), Italy
P.O. di Polistena
🇮🇹Polistena, (rc), Italy
AO "Giuseppe Foscati"
🇮🇹Avellino, Italy
Ospedale "S. Paolo"
🇮🇹Bari, Italy
Ospedale di Bentivoglio
🇮🇹Bologna, Italy
Ospedale Maggiore di Bologna Medicina D
🇮🇹Bologna, Italy
Ospedale M. Bufalini di Cesena
🇮🇹Cesena, Italy
P.O. "SS. Trinità"
🇮🇹Cagliari, Italy
Ospedale di Faenza
🇮🇹Faenza, Italy
Ospedale di Alba e Bra
🇮🇹Cuneo, Italy
Ospedale "Careggi"
🇮🇹Firenze, Italy
P.O di Frattamaggiore
🇮🇹Frattamaggiore, Italy
AOU Careggi
🇮🇹Firenze, Italy
Ospedale del Mare
🇮🇹Napoli, Italy
Azienda Ospedaliero Universitaria di Novara
🇮🇹Novara, Italy
A.O.U. di Perugia
🇮🇹Perugia, Italy
Ospedale di Rimini - Medicina 1 COVID
🇮🇹Rimini, Italy
Ospedale "Vannini"
🇮🇹Roma, Italy
Ospedale di Rimini -Sub intensiva COVID
🇮🇹Rimini, Italy
Ospedale "San Paolo" di Savona
🇮🇹Savona, Italy
PO SS Annunziata AOU Sassari
🇮🇹Sassari, Italy
Ospedale "Mauriziano"
🇮🇹Torino, Italy
Ospedale "Circolo-Macchi"
🇮🇹Varese, Italy
Ospedale Fatebenefratelli Isola Tiberina
🇮🇹Roma, Italy