Background: COVID-19 has quickly become a global pandemic with a substantial number of deaths and is a considerable burden for healthcare systems worldwide. Although most cases are paucisymptomatic and limited to the viral infection-related symptoms, some patients evolve to a second phase, with an impaired inflammatory response (cytokine storm) that may lead to acute respiratory distress syndrome and death. This is thought to be caused by increased bradykinin synthesis. Methods: ICAT-COVID is a multicenter, randomized, open-label, proof-of-concept phase II clinical trial assessing the clinical efficacy and safety of adding icatibant to the standard of care in patients hospitalized with COVID-19 without invasive mechanical ventilation. Patients hospitalized with a confirmed COVID-19 pneumonia diagnosis (RT-PCR or antigen test ≤ 10 days prior to randomization, and radiographic evidence of pulmonary infiltrates), rated “4” or “5” on the WHO’s clinical status scale, are eligible. Patients will be randomized on a 1:1 ratio to either standard of care-plus-icatibant (experimental group) or to standard of care alone (control group). The experimental group will receive 30 mg of icatibant subcutaneously 3 times a day for 3 days (for a total of 9 doses). The expected sample size is 120 patients (60 per group) from 2 sites in Spain. Primary outcomes are the efficacy and safety of Icatibant. The main efficacy outcome is the number of patients reaching grades “2” or “1” on the WHO scale within 10 days of starting treatment. Secondary outcomes include “long-term efficacy”: number of patients discharged who do not present COVID-19-related relapse or comorbidity up until 28 days after discharge, and mortality. Discussion: Icatibant, a bradykinin type 2 receptor antagonist with proven effectiveness and safety against hereditary angioedema attacks, may be beneficial for COVID-19 patients by inhibiting bradykinin’s action on endothelial cells and by inhibiting the SARS-CoV-2 M protease. Our working hypothesis is that treatment with standard of care-plus-icatibant is effective and safe to treat patients infected with SARS-CoV-2 admitted to hospital for pneumonia without invasive mechanical ventilation. Trial registration: EudraCT 2020-002166-13. ClinicalTrials.gov NCT04978051

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic started in December 2019 and still is a major global health challenge. Lockdown measures and social distancing sparked a global shift towards online learning, which deeply impacted universities’ daily life, and the University of Barcelona (UB) was not an exception. Accordingly, we aimed to determine the impact of the SARS-CoV-2 pandemic at the UB. To that end, we performed a cross-sectional study on a sample of 2784 UB members (n = 52,529). Participants answered a brief, ad hoc, online epidemiological questionnaire and provided a nasal swab for reverse transcription polymerase chain reaction (RT-PCR) SARS-CoV-2 analysis and a venous blood sample for SARS-CoV-2 IgG antibody assay. Total prevalence of SARS-CoV-2 infection (positive RT-PCR or positive IgG) was 14.9% (95%CI 13.3 to 17.0%). Forty-four participants (1.6%, 95%CI: 1.2–2.1%) were positive for SARS-CoV-2 RT-PCR. IgG against SARS-CoV-2 was observed in 12.8% (95%CI: 11.6–14.1%) of participants. Overall, while waiting for population vaccination and/or increased herd immunity, we should concentrate on identifying and isolating new cases and their contacts.

Background: COVID-19 has quickly become a global pandemic with a substantial number of deaths and a substantial burden for healthcare systems worldwide. Although most cases are paucisymptomatic and limited to the viral infection related symptoms, some patients evolve to a second phase, with an impaired inflammatory response (cytokine storm) that may lead to acute respiratory distress syndrome and death. This is thought to be caused by an increased bradykinin synthesis. Methods: ICAT-COVID is a multicenter, randomized, open-label, proof-of-concept phase II clinical trial assessing the clinical efficacy and safety of adding Icatibant on the standard of care in patients hospitalized with COVID-19 without invasive mechanical ventilation. Patients hospitalized with a confirmed COVID-19 pneumonia diagnosis (RT-PCR or antigen test ≤ 10 days prior to randomization, and radiographic evidence of pulmonary infiltrates), rated ‘4’ or ‘5’ on the WHO’s clinical status scale are eligible. Patients will be randomized on a 1:1 ratio to either standard of care-plus-Icatibant (experimental group) or to standard of care alone (control group). The experimental group will receive 30 mg of Icatibant subcutaneously 3 times a day for 3 days (for a total of 9 doses). The expected sample size is of 120 patients (60 per group) gathered from 2 centers in Spain. Primary outcomes are Icatibant’s efficacy and safety. The main efficacy outcome is the number of patients reaching grades ‘2’ or ‘1’ on the WHO Scale within 10 days of treatment start. Among the secondary outcomes are ‘long-term efficacy’: number of patients discharged who do not present any COVID-19-related relapse or comorbidity up until 28 days after discharging, and mortality. Discussion: Icatibant, a bradykinin type 2 receptor antagonist with proven effectiveness and safety against hereditary angioedema attacks, may be beneficial for COVID-19 patients by inhibiting bradykinin’s action on endothelial cells and by inhibiting the SARS-CoV-2 M protease. Our working hypothesis is that treatment with Standard of Care-plus-Icatibant is effective and safe to treat patients infected with SARS-CoV-2 admitted to hospital for pneumonia without invasive mechanical ventilation.Trial registration: EudraCT: 2020-002166-13; ClinicalTrials.gov: NCT04978051