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

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ClinicalTrials.gov Identifier: NCT04365725
Recruitment Status : Recruiting
First Posted : April 28, 2020
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.

Condition or disease Intervention/treatment
COVID-19 Drug: Remdesivir

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Multicenter, Retrospective Study of the Effects of Remdesivir in the Treatment of Severe Covid-19 Infections.
Actual Study Start Date : May 5, 2020
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Intervention Details:
  • Drug: Remdesivir
    Compassionate provision


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Clinical course on Day 3. [ Time Frame: 3 days ]
    Explore the prognostic factors of the clinical course of patients on Day 3

  2. Clinical course on Day 8 [ Time Frame: 8 days ]
    Explore the prognostic factors of the clinical course of patients on Day 8

  3. Clinical course on Day 11. [ Time Frame: 11 days ]
    Explore the prognostic factors of the clinical course of patients on Day11

  4. Clinical course on Day 29. [ Time Frame: 29 days ]
    Explore the prognostic factors of the clinical course of patients on D29.

  5. Duration of treatment [ Time Frame: 29 days ]
    Duration of treatment with remdesivir

  6. 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.

  7. Duration without mechanical ventilation [ Time Frame: 29 days ]
    Duration without mechanical ventilation within 29 days of initiation of treatment with remdesivir

  8. Mortality [ Time Frame: 29 days ]
    Mortality at 29 days after initiation of treatment with remdesivir.

  9. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult hospital patients diagnosed with COVID-19
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04365725


Contacts
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Contact: Jeremie ZERBIT, PharmaD +33158412297 jeremie.zerbit@aphp.fr

Locations
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France
Hôpital Cochin Recruiting
Paris, France, 75014
Contact: Jérémie ZERBIT, PharmaD    +33158412297    jeremie.zerbit@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jérémie ZERBIT, PharmaD Assistance Publique - Hôpitaux de Paris
Publications:
Gonçalves A, Bertrand J, Ke R, Comets E, Lamballerie X de, Malvy D, et al. Timing of antiviral treatment initiation is critical to reduce SARS-Cov-2 viral load. medRxiv. 7 avr 2020; 2020.04.04.20047886.
Warren TK, Jordan R, Lo MK, Ray AS, Mackman RL, Soloveva V, Siegel D, Perron M, Bannister R, Hui HC, Larson N, Strickley R, Wells J, Stuthman KS, Van Tongeren SA, Garza NL, Donnelly G, Shurtleff AC, Retterer CJ, Gharaibeh D, Zamani R, Kenny T, Eaton BP, Grimes E, Welch LS, Gomba L, Wilhelmsen CL, Nichols DK, Nuss JE, Nagle ER, Kugelman JR, Palacios G, Doerffler E, Neville S, Carra E, Clarke MO, Zhang L, Lew W, Ross B, Wang Q, Chun K, Wolfe L, Babusis D, Park Y, Stray KM, Trancheva I, Feng JY, Barauskas O, Xu Y, Wong P, Braun MR, Flint M, McMullan LK, Chen SS, Fearns R, Swaminathan S, Mayers DL, Spiropoulou CF, Lee WA, Nichol ST, Cihlar T, Bavari S. Therapeutic efficacy of the small molecule GS-5734 against Ebola virus in rhesus monkeys. Nature. 2016 Mar 17;531(7594):381-5. doi: 10.1038/nature17180. Epub 2016 Mar 2. Erratum in: ACS Chem Biol. 2016 May 20;11(5):1463.

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04365725    
Other Study ID Numbers: APHP200522
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
COVID-19
Remdesivir
Additional relevant MeSH terms:
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Infection