NCT05239988

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,004

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

30 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

7 months

First QC Date

February 9, 2022

Last Update Submit

February 27, 2024

Conditions

Hospitalization

Keywords

COVID-19 patientsRemdesivir

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Interventions

no experimental interventionOTHER

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

COVID-19 patients treated with Remdesivir

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (30)

Ospedale "Mons. Giovanni Galliano"

Acqui Terme, (AL), Italy

Location

Ente Ecclesiastico "F. Miulli"

Acquaviva delle Fonti, (BA), Italy

Location

Ospedale di Andria

Andria, (BT), Italy

Location

P.O. di Garbagnate

Garbagnate Milanese, (MI), Italy

Location

Ospedale di Melegnano

Melegnano, (MI), Italy

Location

Ospedale Broni-Stradella

Stradella, (PV), Italy

Location

P.O. di Polistena

Polistena, (RC), Italy

Location

AO "Giuseppe Foscati"

Avellino, Italy

Location

Ospedale "S. Paolo"

Bari, Italy

Location

Ospedale di Bentivoglio

Bologna, Italy

Location

Ospedale Maggiore di Bologna Medicina D

Bologna, Italy

Location

P.O. "SS. Trinità"

Cagliari, Italy

Location

Ospedale M. Bufalini di Cesena

Cesena, Italy

Location

Ospedale di Alba e Bra

Cuneo, Italy

Location

Ospedale di Faenza

Faenza, Italy

Location

AOU Careggi

Florence, Italy

Location

Ospedale "Careggi"

Florence, Italy

Location

P.O di Frattamaggiore

Frattamaggiore, Italy

Location

Ospedale Galliera

Genova, Italy

Location

Ospedale del Mare

Napoli, Italy

Location

Azienda Ospedaliero Universitaria di Novara

Novara, Italy

Location

A.O.U. di Perugia

Perugia, Italy

Location

Ospedale di Rimini - Medicina 1 COVID

Rimini, Italy

Location

Ospedale di Rimini -Sub intensiva COVID

Rimini, Italy

Location

Ospedale "Vannini"

Roma, Italy

Location

Ospedale Fatebenefratelli Isola Tiberina

Roma, Italy

Location

PO SS Annunziata AOU Sassari

Sassari, Italy

Location

Ospedale "San Paolo" di Savona

Savona, Italy

Location

Ospedale "Mauriziano"

Torino, Italy

Location

Ospedale "Circolo-Macchi"

Varese, Italy

Location

Study Officials

  • Andrea Fontanella, MD

    FADOI FOUNDATION

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 15, 2022

Study Start

November 24, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

IT(30)