Suspected Serious Adverse Drug Reactions in Hospitalized COVID-19 Patients (preprint)

BACKGROUND: From March to April 2020, Spain was the center of the SARS-CoV-2 pandemic, particularly Madrid with approximately 30% of the cases in Spain. The aim of this study is to report the suspected serious adverse drug reactions (SADRs) in COVID-19 patients versus non-COVID-19 patients detected by the prospective pharmacovigilance program based on automatic laboratory signals (ALSs) in the hospital (PPLSH) during that period. We also compared the results with the suspected SADRs detected during the same period for 2019. METHODS: All ALSs that reflected potential SADRs (including neutropenia, pancytopenia, thrombocytopenia, anemia, eosinophilia, leukocytes in cerebrospinal fluid, hepatitis, pancreatitis, acute kidney injury, rhabdomyolysis and hyponatremia were prospectively monitored in hospitalized patients during the study periods. We analyzed the incidence and the distribution of causative drugs for the COVID-19 patients. RESULTS: The incidence rate of SADRs detected in the COVID-19 patients was 760.63 (95% CI 707.89–816.01) per 10,000 patients, 4.75-fold higher than the SADR rate for non-COVID-19 patients (160.15 per 10,000 patients,95% CI 137.09–186.80), and 5.84-fold higher than the SADR rate detected for the same period in 2019 (130.19 per 10,000 patients, 95% CI 109.53–154.36). The most frequently related drugs were tocilizumab (59.84%), dexketoprofen (13.93%), azithromycin (8.43%), lopinavir-ritonavir (7.35%), dexamethasone (7.62%), and chloroquine/hydroxychloroquine (6.91%). CONCLUSIONS: The incidence rate of SADRs detected by the PPSLH in patients with COVID-19 was 4.75-fold higher than that of the non-COVID-19 patients. Caution is recommended when using medications for COVID-19 patients, especially drugs that are hepatotoxic, myotoxic, and those that induce thromboembolic events.

A cohort of patients with COVID-19 in a major teaching hospital in Europe (preprint)

BACKGROUND Since the confirmation of the first patient infected with SARS-CoV-2 in Spain in January 2020, the epidemic has grown rapidly, with the greatest impact on the Madrid region. This article describes the first 2226 consecutive adult patients with COVID-19 admitted to the La Paz University Hospital in Madrid. METHODS Our cohort included all consecutively admitted patients who were hospitalized and who had a final outcome (death or discharge) in a 1286-bed hospital of Madrid (Spain) from February 25th (first case admitted) to April 19th, 2020. Data was entered manually into an electronic case report form, which was monitored prior to the analysis. RESULTS We consecutively included 2226 adult patients admitted to the hospital who either died (460) or were discharged (1766). The patients median age was 61 years; 51.8% were women. The most common comorbidity was arterial hypertension (41.3%). The most common symptoms on admission were fever (71.2%). The median time from disease onset to hospital admission was 6 days. Overall mortality was 20.7% and was higher in men (26.6% vs 15.1%). Seventy-five patients with a final outcome were transferred to the ICU (3.4%). Most patients admitted to the ICU were men, and the median age was 64 years. Baseline laboratory values on admission were consistent with an impaired immune-inflammatory profile. CONCLUSIONS We provide a description of the first large cohort of hospitalized patients with COVID-19 in Europe. Advanced age, male gender, the presence of comorbidities and abnormal laboratory values were more common among the patients with fatal outcomes.