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

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.