Observational Study in COVID-19 Patients Treated With Remdesivir (RECOVER)

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

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.

Study Overview

• Status: Completed
• Conditions: Hospitalization
• Intervention / Treatment: Other: no experimental intervention

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.

• Study Type: Observational
• Enrollment (Actual): 1004

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
COVID-19 patients treated with Remdesivir; Patients suffering from SARS-CoV-2 and treated with Remdesivir admitted to Internal Medicine Unit	Other: no experimental intervention; There will not be any experimental intervention. The study will be conducted according with normal clinical practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Fadoi Foundation, Italy
• Investigators: Study Director: Andrea Fontanella, MD, FADOI FOUNDATION

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2021
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: February 9, 2022
• First Submitted That Met QC Criteria: February 14, 2022
• First Posted (Actual): February 15, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Remdesivir; COVID-19 patients
• Other Study ID Numbers: FADOI.02.2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No