Observational Study in COVID-19 Patients Treated With Remdesivir

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hospitalization

Intervention / Treatment
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* Other: no experimental intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19 patients, Remdesivir