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

COVID-19 Clinical Trial

— REMDECO-19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04365725
• Other study ID #: APHP200522
• Status: Completed
• Start date: May 5, 2020
• Est. completion date: June 12, 2020

Study information

• Verified date: April 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 12, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Infection

Intervention

Drug:
• Remdesivir
Compassionate provision

Locations

Country	Name	City	State
France	Hôpital Cochin	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical course on Day 15.	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	Clinical course on Day 3.	Explore the prognostic factors of the clinical course of patients on Day 3	3 days
Secondary	Clinical course on Day 8	Explore the prognostic factors of the clinical course of patients on Day 8	8 days
Secondary	Clinical course on Day 11.	Explore the prognostic factors of the clinical course of patients on Day11	11 days
Secondary	Clinical course on Day 29.	Explore the prognostic factors of the clinical course of patients on D29.	29 days
Secondary	Duration of treatment	Duration of treatment with remdesivir	29 days
Secondary	Sepsis-related Organ Failure Assessment score	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
Secondary	Duration without mechanical ventilation	Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir	29 days
Secondary	Mortality	Mortality at 29 days after initiation of treatment with remdesivir.	29 days
Secondary	cumulative incidence of grade 3 and 4 adverse events (AEs).	Evaluate the safety of the treatment with cumulative incidence of grade 3 and 4 adverse events (AEs).	29 days