Treatment for COVID-19—a cohort study from Northern Italy
Retrospective 600 hospitalized patients in Italy, showing lower mortality with HCQ treatment, without reaching statistical significance (
p = 0.1).
Although the 28% lower mortality is not statistically significant, it is consistent with the significant 22% lower mortality
[18‑27%] from meta analysis of the
232 mortality results to date.
risk of death, 28.0% lower, HR 0.72, p = 0.10, treatment 474, control 126, multivariable Cox proportional hazards.
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Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
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Guglielmetti et al., 25 Oct 2021, retrospective, Italy, peer-reviewed, 19 authors, study period 21 February, 2020 - 15 May, 2020.
Abstract: www.nature.com/scientificreports
OPEN
Treatment for COVID‑19—a cohort
study from Northern Italy
Lorenzo Guglielmetti1,2,3*, Daniela Aschieri4, Irina Kontsevaya5,6,7, Francesco Calabrese3,
Alessandra Donisi8, Alberto Faggi3, Patrizia Ferrante3,9, Elisa Fronti3, Laura Gerna3,
Maria Cristina Leoni3, Franco Paolillo3, Giovanna Ratti3, Alessandro Ruggieri3,
Daria Sacchini3, Marta Scotti3, Caterina Valdatta3, Marco Stabile10, Gloria Taliani3,11,12 &
Mauro Codeluppi3
Multicentre, retrospective cohort study with multivariable Cox proportional-hazards modelling and
survival-time inverse-probability-weighting, evaluating the impact of different treatments on survival
of proven COVID-19 patients admitted to two Hospitals in the province of Piacenza, Italy. Use of
tocilizumab and of high doses of low molecular weight heparin, but not of antivirals (either alone
or in combination), azithromycin, and any corticosteroid, was independently associated with lower
mortality. Our results support further clinical evaluation of high doses of low molecular weight heparin
and tocilizumab as COVID-19 therapeutics.
Italy was struck by the first epidemic wave of coronavirus disease 2019 (COVID-19) in early 20201. Overall,
about 44 000 excess deaths occurred in this 3-month period2, largely concentrated in Northern Italy. At that
time, virtually no evidence was available on the optimal management of COVID-19. In this study, we aim to
evaluate the impact of the medical interventions on survival in hospitalized COVID-19 patients in the province
of Piacenza, Italy.
Methods
A multicentre, retrospective cohort study was performed among patients hospitalized for COVID-19 from
February 21st (date of the first reported COVID-19 case) to May 15th, 2020, at two Hospitals in the province
of Piacenza: Guglielmo da Saliceto and Castel San Giovanni. Data for consecutive patients were extracted from
electronic medical files, cross-checked, and collated in an anonymized database. Data were censored on June
30th, 2020. Adult (18 years and older) confirmed COVID-19 cases with SARS-CoV-2 reverse transcriptase realtime polymerase chain reaction test on nasal/pharyngeal s wab3 were included. Part of the cohort was described
previously4. The study was approved by the local Ethics Committee (Area Vasta Emilia Nord), which waived the
requirement for informed consent. Continuous data were presented as median and interquartile range (IQR), categorical data as counts and proportions. Low molecular weight heparin was defined as high-dose (HD-LMWH)
when given at therapeutic posology (i.e. enoxaparin 6000 international units daily or more) according to drug
package inserts. Prescription of treatment (including the choice of the drug and its posology) was heterogeneous
in terms of indication as little evidence and no specific recommendations on their use were available. Missing
data were handled with multiple imputation using chained equations with 10 imputed datasets. The proportion
of missing observations ranged between 0 and 9%. Multivariable Cox proportional-hazards models were used to
assess the association of treatment variables with survival, controlling for potential confounders chosen according
to univariate results and a priori plausibility. Two models were used: (1) including a variable coding for treatment
with any antiviral drug, and (2) including variables coding for the use of hydroxychloroquine, protease inhibitors,
1
Sorbonne Université, INSERM, U1135, Centre..
Late treatment
is less effective
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