HospitalizationRECOVERNCT05239988
Observational Study in COVID-19 Patients Treated With Remdesivir
An observational study of Hospitalization, run by Fadoi Foundation, Italy at 30 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hospitalization
- What is being tested?
- no experimental intervention
- How many people
- 1,004 participants
- Where
- 30 sitesItaly
- Study dates
- 24 Nov 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
30 sites in 1 country.
30 sites in 1 country
Italy30 sites
Ente Ecclesiastico "F. Miulli"
Acquaviva delle Fonti, (BA)
Ospedale "Mons. Giovanni Galliano"
Acqui Terme, (AL)
Ospedale di Andria
Andria, (BT)
AO "Giuseppe Foscati"
Avellino
Ospedale "S. Paolo"
Bari
Ospedale di Bentivoglio
Bologna
Ospedale Maggiore di Bologna Medicina D
Bologna
P.O. "SS. Trinità"
Cagliari
Ospedale M. Bufalini di Cesena
Cesena
Ospedale di Alba e Bra
Cuneo
Ospedale di Faenza
Faenza
AOU Careggi
Florence
Ospedale "Careggi"
Florence
P.O di Frattamaggiore
Frattamaggiore
P.O. di Garbagnate
Garbagnate Milanese, (MI)
Ospedale Galliera
Genova
Ospedale di Melegnano
Melegnano, (MI)
Ospedale del Mare
Naples
Azienda Ospedaliero Universitaria di Novara
Novara
A.O.U. di Perugia
Perugia
P.O. di Polistena
Polistena, (RC)
Ospedale di Rimini - Medicina 1 COVID
Rimini
Ospedale di Rimini -Sub intensiva COVID
Rimini
Ospedale "Vannini"
Roma
Ospedale Fatebenefratelli Isola Tiberina
Roma
PO SS Annunziata AOU Sassari
Sassari
Ospedale "San Paolo" di Savona
Savona
Ospedale Broni-Stradella
Stradella, (PV)
Ospedale "Mauriziano"
Torino
Ospedale "Circolo-Macchi"
Varese
About this study
Official title: 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.
Read the 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.
- Conditions
- Hospitalization
- Being tested
- no experimental intervention
- Keywords
- COVID-19 patients, Remdesivir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no experimental interventionOther
There will not be any experimental intervention. The study will be conducted according with normal clinical practice
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 patients treated with Remdesivir | Patients suffering from SARS-CoV-2 and treated with Remdesivir admitted to Internal Medicine Unit Receives: Other: no experimental intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start24 Nov 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HospitalizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,004 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fadoi Foundation, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Fontanella, MD, Study director, FADOI FOUNDATION
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05239988
- Sponsor's protocol ID
- FADOI.02.2021
- Acronym
- RECOVER
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2022
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Retrospective Observational Study in Patients Treated With Remdesivir Suffering From SARS-CoV-2 Hospitalized in Internal Medicine
- ClinicalTrials.gov ID
- NCT05239988
- Acronym / sponsor ID
- RECOVER / FADOI.02.2021
- Conditions
- Hospitalization
- Keywords
- COVID-19 patients, Remdesivir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,004 participants (actual)
- Lead sponsor
- Fadoi Foundation, ItalyUniversity, hospital or other
- Study start
- 24 Nov 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COVID-19 patients treated with Remdesivir | – | Other: no experimental interventionPatients suffering from SARS-CoV-2 and treated with Remdesivir admitted to Internal Medicine Unit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no experimental interventionThere will not be any experimental intervention. The study will be conducted according with normal clinical practice | Other | COVID-19 patients treated with Remdesivir |
Primary outcome
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
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Fontanella, MD study director
FADOI FOUNDATION
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hospitalization, run by Fadoi Foundation, Italy at 30 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
characteristics of COVID-19 patients (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.