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NCT Number: NCT05239988

Observational Study in COVID-19 Patients Treated With Remdesivir

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.

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Key information

Conditions

Hospitalization

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale "Mons. Giovanni Galliano", Acqui Terme, (AL), Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

no experimental intervention

Other

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

Primary outcomes

  1. characteristics of COVID-19 patients

    Time frame: 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

  2. methods of treatment with Remdesivir and the main outcomes

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Fadoi Foundation, Italy

Other

Registry information

Official study title

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

Acronym: RECOVER

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2022
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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