ABSTRACT
Almost two years after remdesivir was approved and extensively used in numerous clinical studies for the treatment of COVID-19 patients, there is still no clear recommendation for the time and phase of the disease of remdesivir administration. This retrospective observational study included adults (≥18 years) with severe COVID-19, radiologically confirmed pneumonia, a need for supplemental oxygen and an interval from symptom onset to enrolment of 10 days or less. All patients were treated with remdesivir for 5 to 10 days, or with clinical improvement within that period. The primary goal was the outcome in patients treated with remdesivir during the early stage of the disease considering the different disease severity. The median time from symptom onset to treatment was 8.4 days (3-10). Clinical improvements and good outcomes were observed in 104 of 137 patients (75.9%); 33 (24.1%) of 137 patients died. Subgroup analyses showed that the mortality rate was significantly lower in moderately ill patients (3 out of 51 patients; 5.9%) than in the group of severely/critically ill patients (30 out of 86 patients; 34.8%; p < 0.005). Older age, rise of CRP and CT score were shown to be significant predictors of disease outcome. Overall, remdesivir was well tolerated, and the treatment was discontinued in only four patients. The results of this observational study in 137 patients with different disease severity contribute to the attitude concerning remdesivir administration in the early stage of COVID-19, at least in moderately ill patients with a high risk of progression, before the transition to a more severe stage.
ABSTRACT
This study assessed the diagnostic performance of the new COVID19SEROSpeed IgM/IgG rapid test (BioSpeedia, a spinoff of the Pasteur Institute of Paris) for the detection of antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in comparison to other commercial antibody assays through a large cross-European investigation. The clinical specificity was assessed on 215 prepandemic sera (including some from patients with viral infections or autoimmune disorders). The clinical sensitivity was evaluated on 710 sera from 564 patients whose SARS-CoV-2 infection was confirmed by quantitative reverse transcription-PCR (qRT-PCR) and whose antibody response was compared to that measured by five other commercial tests. The kinetics of the antibody response were also analyzed in seven symptomatic patients. The specificity of the test (BioS) on prepandemic specimens was 98.1% (95% confidence interval [CI], 96.2% to 99.4%). When tested on the 710 pandemic specimens, BioS showed an overall clinical sensitivity of 86.0% (95% CI, 0.83 to 0.89), with good concordance with the Euroimmun assay (overall concordance of 0.91; Cohen's kappa coefficient of 0.62). Due in part to simultaneous detection of IgM and IgG for both S1 and N proteins, BioS exhibited the highest positive percent agreement at ≥11 days post-symptom onset (PSO). In conclusion, the BioS IgM/IgG rapid test was highly specific and demonstrated a higher positive percentage of agreement than all the enzyme-linked immunosorbent assay/chemiluminescence immunoassay (ELISA/CLIA) commercial tests considered in this study. Moreover, by detecting the presence of antibodies prior to 11 days PSO in 78.2% of the patients, the BioS test increased the efficiency of the diagnosis of SARS-CoV-2 infection in the early stages of the disease.