Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections (REMDECO-19)

April 16, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.

This study is a retrospective cohort trial to assess the efficacy of remdesivir in hospitalized adult patients diagnosed with COVID-19. The study is a multicenter trial which will be carried out on different sites in France. This trial is retrospective and will analyze the data collected during treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

COVID-19 is a respiratory disease caused by a new coronavirus (SARS-CoV-2) and causes significant morbidity and mortality. There is currently no approved treatment for the treatment of patients with COVID-19. Global efforts to evaluate new antivirals and therapeutic strategies to treat COVID-19 have intensified. To quickly propose a first line of defense and fight against the virus in hospitalized patients, the World Health Organization (WHO) relies on already existing drugs, "repositioned", which are immediately available in large quantities and present a good security profile. Remdesivir (GS-5734) is a broad spectrum nucleotide analogue that inhibits RNA-dependent RNA polymerase activity among a diverse group of RNA viruses. Non-clinical and clinical data suggest that remdesivir may be useful for the treatment of COVID-19. WHO has identified remdesivir as a candidate drug of interest to be studied in clinical trials. Compassionate provision of the drug allowed its use before clinical trials began. This retrospective cohort study is designed to analyze the data collected during the routine care of patients who have benefited from this compassionate provision.

The data collected in real life during care will allow a multivariate analysis quickly providing elements of response on a typology of patients and level of progression of the disease for which remdesivir would bring a more or less significant clinical benefit. Multivariate analysis of these data will allow the identification of variables at the initiation of treatment with remdesivir that are potentially predictive of its clinical efficacy.

The period for collecting data collected during treatment for an individual subject is 30 days. The retrospective collection begins on the day before initiation of treatment with remdesivir up to 29 days after. A note of information and of no objection to the collection of data will be sent to the patient. The data collected comes from the patient's medical records. The observations will be entered by investigative doctors and or clinical study technicians.

Statistical analysis will be carried out using SAS 9.3 and / or R software. All the analyzes carried out will follow the recommendations of STROBE for observational studies. A detailed statistical analysis plan will be carried out before basic freezing and data analysis. Quantitative data will be described as the mean and standard deviation or medians and quartiles depending on the distribution of the data. Qualitative data will be described in terms of numbers and percentages. Comparisons of quantitative data will be analyzed using the student or wilcoxon test depending on the test application conditions, and comparisons of categorical variables will be made using the Chi2 or Fisher test, if appropriate. Multivariate models will be produced to explore the factors associated with patient prognosis. The clinical development of patients described on a 7-point ordinal scale will be divided into two in order to create logistic models. The entire process of selecting variables in the models will be described in the analysis plan which will be validated before the database freezes.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75014
        • Hopital Cochin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult hospital patients diagnosed with COVID-19

Description

Inclusion Criteria:

  • Adult ≥ 18 years old.
  • SARS-CoV-2 infection confirmed.
  • Hospitalized patients who received at least one administration of remdesivir therapy outside of clinical trials

Exclusion Criteria:

  • Patients included in a clinical trial testing remdesivir as an investigational drug.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical course on Day 15.
Time Frame: 15 days
Study the prognostic factors of the clinical course of patients on Day 15 under treatment with remdesivir. Clinical progress will be categorized using a 7-point ordinal scale.
15 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical course on Day 3.
Time Frame: 3 days
Explore the prognostic factors of the clinical course of patients on Day 3
3 days
Clinical course on Day 8
Time Frame: 8 days
Explore the prognostic factors of the clinical course of patients on Day 8
8 days
Clinical course on Day 11.
Time Frame: 11 days
Explore the prognostic factors of the clinical course of patients on Day11
11 days
Clinical course on Day 29.
Time Frame: 29 days
Explore the prognostic factors of the clinical course of patients on D29.
29 days
Duration of treatment
Time Frame: 29 days
Duration of treatment with remdesivir
29 days
Sepsis-related Organ Failure Assessment score
Time Frame: Day 3, 8, 11, 15 and 29
PaO2 / FiO2 and artificial ventilation; platelets; bilirubin; average blood pressure and use of vasoactive drugs; Glasgow score; creatinine.
Day 3, 8, 11, 15 and 29
Duration without mechanical ventilation
Time Frame: 29 days
Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir
29 days
Mortality
Time Frame: 29 days
Mortality at 29 days after initiation of treatment with remdesivir.
29 days
cumulative incidence of grade 3 and 4 adverse events (AEs).
Time Frame: 29 days
Evaluate the safety of the treatment with cumulative incidence of grade 3 and 4 adverse events (AEs).
29 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Jérémie ZERBIT, PharmaD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2020

Primary Completion (Actual)

June 12, 2020

Study Completion (Actual)

June 12, 2020

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 25, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 19, 2021

Last Update Submitted That Met QC Criteria

April 16, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP200522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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