Observational Study in COVID-19 Patients Treated With Remdesivir

Completed

• 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.

Study Timeline

• Study Start: 2021-11-24
• Study First Submitted: 2022-02-09
• Study First Submitted QC: 2022-02-14
• Study First Posted: 2022-02-15
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-27
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1004

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 & 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).

Trial Locations

Locations (30)

Ospedale "Mons. Giovanni Galliano"; 🇮🇹 Acqui Terme, (al), 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 di Melegnano; 🇮🇹 Melegnano, (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

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