Evaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial.

BACKGROUND: COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. At the time this clinical trial was planned, there were no available vaccine or therapeutic agents with proven efficacy, but the severity of the condition prompted the use of several pharmacological and non-pharmacological interventions. It has long been hypothesized that the use of convalescent plasma (CP) from infected patients who have developed an effective immune response is likely to be an option for the treatment of patients with a variety of severe acute respiratory infections (SARI) of viral etiology. The aim of this study is to assess the efficacy and safety of convalescent plasma in adult patients with severe COVID-19 pneumonia. METHODS/DESIGN: The ConPlas-19 study is a multicenter, randomized, open-label controlled trial. The study has been planned to include 278 adult patients hospitalized with severe COVID-19 infection not requiring mechanical ventilation (invasive or non-invasive). Subjects are randomly assigned in a 1:1 ratio (139 per treatment arm), stratified by center, to receive intravenously administered CP (single infusion) plus SOC or SOC alone, and are to be followed for 30 days. The primary endpoint of the study is the proportion of patients that progress to category 5, 6, or 7 (on the 7-point ordinal scale proposed by the WHO) at day 15. Interim analyses for efficacy and/or futility will be conducted once 20%, 40%, and 60% of the planned sample size are enrolled and complete D15 assessment. DISCUSSION: This clinical trial is designed to evaluate the efficacy and safety of passive immunotherapy with convalescent plasma for the treatment of adult patients hospitalized with COVID-19. The results of this study are expected to contribute to establishing the potential place of CP in the therapeutics for a new viral disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT04345523 . Registered on 30 March, 2020. First posted date: April 14, 2020.

Role of rhinovirus in hospitalized infants with respiratory tract infections in Spain.

BACKGROUND: Rhinovirus is a recognized cause of common cold, proven to cause asthma exacerbations in children. In Spain, no description exists, as yet, as to the degree of burden rhinovirus infections represent among hospitalized infants. Our aim was to describe rhinovirus infections in hospitalized children, under 2 years of age, and to compare these with patients infected with respiratory syncytial virus (RSV). PATIENTS AND METHODS: The prospective study was performed between September 2003 and July 2005, in children <2 years of age, admitted at the Severo Ochoa Hospital (Leganés, Madrid) with fever or respiratory tract infection and with positive rhinovirus detection in the nasopharyngeal aspirate samples. Virologic diagnosis was made by multiplex reverse transcription-polymerase chain reaction and for some virus by direct immunofluorescent assay in nasopharyngeal samples. Demographic and clinical data of those patients with rhinovirus infection were described and compared with a group of 86 patients, infected only with RSV, randomly selected from the same population. RESULTS: We detected 85 children admitted to hospital with rhinovirus infection. Rhinovirus was the cause of 25% of all admissions, among the total of 340 under 2-year olds diagnosed with fever or respiratory tract infection. Rhinovirus was the second viral agent identified, after RSV. Clinical diagnosis was recurrent wheezing in 48.2%; bronchiolitis in 36.5%; and pneumonia in 3.5%. Fever was present in 60% of the patients. Radiologic infiltrates were found in 22.4% of the children. In 50.6% of the infants, oxygen saturation under 95% was detected, at the time of admission. Hypoxia was present in RSV-infected children more frequently (P = 0.005). Also, in this group, final diagnosis was, most frequently, bronchiolitis (P = 0.0001), and rhinovirus-infected patients were most frequently males (P = 0.004). CONCLUSIONS: Rhinovirus was detected in hospitalized infants with respiratory tract disease and was the second most common virus after RSV. In our experience, it was the second etiologic agent associated with recurrent wheezing in hospitalized children, under the age of 2 years.