Covid19909REMNCT04847622
Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
An observational study of Covid19, run by NEAT ID Foundation at 12 sites in 5 countries.
Trial summary
This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Remdesivir
- How many people
- 451 participants
- Where
- 12 sitesin 5 countries
- Study dates
- 12 Feb 2021to 30 Apr 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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: Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.
Who may be able to join
- All Adult participants with COVID-19 confirmed by PCR who meet the following criteria:
- Hospitalised after August 31st,2020
- Receivedat least one dose of Remdesivir(RDV)at anytime during hospitalisation
Who cannot join
- Received Remdesivir as part of a clinical trial, compassionate use or expanded access program
- Received Remdesivir prior to this admission at any other health facility than the research sites and whose health records are available.
Trial locations and contacts
12 sites in 5 countries.
12 sites in 5 countries
Spain5 sites
Hospital Germans Trias i Pujol
Barcelona, 08916
Hospital Clínic de Barcelona
Barcelona
Hospital Universitari Vall d'Herbon
Barcelona
Hospital Clinico Universitario San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
France3 sites
CHU de Nantes
Nantes
Hospital Lariboisiere
Paris, 75010
Hopital Saint-Louis
Paris
United Kingdom2 sites
Royal Free Hospital
London, NW3 2QG
Chelsea & Westminster Hospital
London, SW10 9NH
About this study
Official title: A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.
- Conditions
- Covid19
- Being tested
- Remdesivir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemdesivirDrug
treated with Remdesivir
| Study group | Role | What they receive |
|---|---|---|
| Target Population | Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020. Receives: Drug: Remdesivir |
What is being measured
The primary outcome is the main question the study is designed to answer.
All Case Mortality by Day 28
Occurrence of death within 28 days.
Measured: Day 28
Duration of Hopitalisation
Number of hospital discharges by day 28.
Measured: Day 28
Secondary outcomes (13)
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Clinical status assessed by a 7-point ordinal scale on Day 7 7-point ordinary scale:
- Death
- Hospitalised, on invasive mechanical ventilation or ECMO
- Hospitalised, on non-invasive ventilation or high flow oxygen devices
- Hospitalised, requiring low flow supplemental oxygen
- Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care
- Not hospitalised A higher score indicates a better outcome
Measured: Day 7
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
7-point ordinal scale:
- Death
- Hospitalised, on invasive mechanical ventilation or ECMO
- Hospitalised, on non-invasive ventilation or high flow oxygen devices
- Hospitalised, requiring low flow supplemental oxygen
- Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care
- Not hospitalised A higher score indicates a better outcome
Measured: Day 14
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
NEWS2 is a summary score of six physiological parameters (respiratory rate, oxygen saturation, systolic blood pressure, heart rate, consciousness, temperature, and supplemental oxygen dependency). The parameters are assessed to generate a severity score classified as low: aggregate score 0-4, low - medium/medium: score of 3 in any individual parameter/aggregate score 5-6,high: aggregate score 7 or more. A higher score indicates a greater clinical risk.
Clinical status assessed by a 7-point ordinal scale.7-point ordinary scale:
- Death
- Hospitalised,on invasive mechanical ventilation or ECMO
- Hospitalised,on non-invasive ventilation or high flow oxygen devices
- Hospitalised,requiring low flow supplemental oxygen
- Hospitalised,not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalised,not requiring supplemental oxygen -no longer requires ongoing medical care
- Not hospitalised A higher score indicates a better outcome.
Measured: Day 7, 14, and 28
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Clinical status assessed by a 7-point ordinal clinical status scale on Day 28 (or at last observation if discharged or died prior to this time point) in those still hospitalised after Day 14 7-point ordinary scale:
- Death
- Hospitalised, on invasive mechanical ventilation or ECMO
- Hospitalised, on non-invasive ventilation or high flow oxygen devices
- Hospitalised, requiring low flow supplemental oxygen
- Hospitalised, not requiring supplemental oxygen -requiring ongoing medical care (COVID-19 related or otherwise)
- Hospitalised, not requiring supplemental oxygen -no longer requires ongoing medical care
- Not hospitalised
Measured: Day 28
SpO2 > 94% on Room Air
Number of participants SpO2 > 94% on room air by day 28
Measured: Day 28
Duration of Oxygen Therapy
Median (IQR) duration on oxygen therapy by day 28.
Measured: Day 28
ICU Admission
Intensive care unit admission over entire study period
Measured: Day 28
Duration of ICU
Number of days spent in ICU
Measured: through study completion, 28 days
Mechanical Ventilation/ECMO Use
Use of mechanical ventilation/ECMO (extracorporeal membrane oxygenation) over study period
Measured: Day 28
Timing of Remdesivir Exposure
Median (IQR) time from first symptoms to use of remdesivir
Measured: Day 28
Timing From Hospitalisation to Remdesivir Exposure
Median (IQR) time from hospitalisation to use of remdesivir
Measured: Day 28
Duration of Remdesivir Use
Median (IQR) duration of use of remdesivir
Measured: Day 28
Readmission With COVID-19 Complications
Re-admission with COVID-19 complications or recurrence within 28 days of discharge and outcome
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start12 Feb 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies 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
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- NEAT ID Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847622
- Sponsor's protocol ID
- NEAT ID 909REM
- Acronym
- 909REM
- Status last verified
- Oct 2024
- First submitted
- 17 Mar 2021
- Last updated
- 29 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arber N, Shah PL, Assoumou L, Rokx C, De Castro N, Bakhai A, Soriano Viladomiu A, Mateu L, Lumbreras C, Estrada V, Curran A, Sellier PO, Duffy A, Fletcher C, Mozaffari E, Haubrich R, Hodgkins P, Pozniak A, Raffi F. Clinical outcomes by supplemental oxygen use in remdesivir-treated, hospitalised adults with COVID-19. Infect Dis Now. 2023 Oct;53(7):104760. doi: 10.1016/j.idnow.2023.104760. Epub 2023 Jul 14.
PubMed 37454762
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centre, Multi-country Retrospective Cohort Study to Evaluate the Clinical Outcomes in Adults With Covid-19 Who Have Been Treated With Remdesivir.
- ClinicalTrials.gov ID
- NCT04847622
- Acronym / sponsor ID
- 909REM / NEAT ID 909REM
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- NEAT ID FoundationUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Posted 29 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-centre, multi-country retrospective cohort study. At least 450COVID-19 cases from up to 20 participating study sites who meet all eligibility criteria will be included in the analysis. Deidentified data will be extracted from electronic medical record (EMR) databases, clinical registries, case series or additional sources from participating sites and countries, and then entered into a structured e-CRF system. addition, each site/country will be surveyed to determine the local standard of care therapy for COVID-19 infection and to determine if standard protocols were/are in place for the use of Remdesivir and if/how the protocols changed over time.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Target Population | – | Drug: RemdesivirAdults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with COVID-19 diagnosed and treated with Remdesivir after Aug 31st2020.
Key inclusion criteria (3 listed)
- Hospitalised after August 31st,2020
- Receivedat least one dose of Remdesivir(RDV)at anytime during hospitalisation
Key exclusion criteria (2 listed)
- Received Remdesivir as part of a clinical trial, compassionate use or expanded access program
- Received Remdesivir prior to this admission at any other health facility than the research sites and whose health records are available.
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 |
|---|---|---|
| Remdesivirtreated with Remdesivir | Drug | Target Population |
Primary outcome
All Case Mortality by Day 28
Time frame: Day 28
Occurrence of death within 28 days.
Duration of Hopitalisation
Time frame: Day 28
Number of hospital discharges by day 28.
13 secondary outcomes
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale
Time frame: Day 7
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 14
Time frame: Day 14
Clinical Severity on Day 7, Day 14 and Day 28 Based on National Early Warning Score 2 (NEWS2) Score
Time frame: Day 7, 14, and 28
Clinical Status Assessed by a 7-point Ordinal Clinical Status Scale on Day 28
Time frame: Day 28
SpO2 > 94% on Room Air
Time frame: Day 28
Duration of Oxygen Therapy
Time frame: Day 28
ICU Admission
Time frame: Day 28
Duration of ICU
Time frame: through study completion, 28 days
Mechanical Ventilation/ECMO Use
Time frame: Day 28
Timing of Remdesivir Exposure
Time frame: Day 28
Timing From Hospitalisation to Remdesivir Exposure
Time frame: Day 28
Duration of Remdesivir Use
Time frame: Day 28
Readmission With COVID-19 Complications
Time frame: Day 28
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37454762Arber N, Shah PL, Assoumou L, Rokx C, De Castro N, Bakhai A, Soriano Viladomiu A, Mateu L, Lumbreras C, Estrada V, Curran A, Sellier PO, Duffy A, Fletcher C, Mozaffari E, Haubrich R, Hodgkins P, Pozniak A, Raffi F. Clinical outcomes by supplemental oxygen use in remdesivir-treated, hospitalised adults with COVID-19. Infect Dis Now. 2023 Oct;53(7):104760. doi: 10.1016/j.idnow.2023.104760. Epub 2023 Jul 14.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by NEAT ID Foundation at 12 sites in 5 countries.
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 3 inclusion and 2 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 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain, France, United Kingdom, Israel, Netherlands. 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?
Yes. Results are posted in the registry (first posted 29 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
All Case Mortality by Day 28 (time frame: Day 28). 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?
On the ClinicalTrials.gov record for NCT04847622, which also lists 1 linked publication.
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 29 Nov 2024.