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Topics in Antiviral Medicine ; 29(1):86-87, 2021.
Article in English | EMBASE | ID: covidwho-1250792


Background: Understanding the adaptive immune response to SARS-CoV-2, kinetics, persistence and their relationship with the disease severity would be crucial in order to predict recurrences, reinfections and could serve in the design of vaccination strategies. We sought to characterize IgG and neutralizing antibodies (NAbs) against SARS-CoV-2 in patients who were admitted to hospital with COVID-19 disease. Methods: All patients admitted between March-April 2020 with moderate, severe and critical SARS-CoV-2 pneumonia were prospectively studied. Clinical, laboratory data and IgG against SARS-CoV-2 levels were assessed at baseline (upon admission) and months 1, 3 and 6. NAbs were assessed at month 1, 3 and 6. IgG against the SARS-CoV-2 spike (S) protein was measured in serum by chemiluminescence (LIAISON® SARS-CoV-2 S1/S2, DiaSorin) and results were expressed in arbitrary units (AU)/mL. The neutralizing activity of plasma samples was analyzed in a 293T/hACE2 cell infection test using a surrogate viral inhibition assay that uses human immunodeficiency virus type 1 (HIV-1)-based virus expressing SARS-CoV-2 S protein and Luciferase. For neutralization assays, pseudoviruses were incubated with increasing plasma dilutions (range 1/60-1/14,580) in order to obtain the ID50 values. Results: A total of 110 patients who were discharged from hospital were recruited. Median (range) age was 61 (57-71);61.2% were male and most reported comorbidities were hypertension (39.6%), diabetes (24.3%) and obesity (19.8%). Median time from symptoms onset to admission was 9 days (range 7-11). Median (range) IgG levels (AU/mL) at baseline and months 1, 3 and 6 were 48 (28-81), 168 (134-210), 140 (112-171) and 146 (104-206) respectively. No significant differences were observed in median IgG fold change values up to month 6 among severity groups. Median (range) ID50 values for NAbs at months 1, 3 and 6 were 3938 (1958-6407), 4344 (2335-6752) and 424 (124-1022) respectively. NAb titers presented a significant decrease (overall-10.2-fold change from maximal values) without differences among severity groups (Figure 1 a and b). No reinfections occurred. Conclusion: Specific humoral immune response to SARS CoV-2 in patients requiring hospital admission characterizes for a clear peak between 30 and 90 days after admission followed by a significant decline in titer of NAbs by day 180 regardless of disease severity. Longer follow-up may help to determine the longevity of the specific immune response.

Contemp Clin Trials Commun ; 21: 100716, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1036894


INTRODUCTION: Some COVID-19 patients evolve to severe lung injury and systemic hyperinflammatory syndrome triggered by both the coronavirus infection and the subsequent host-immune response. Accordingly, the use of immunomodulatory agents has been suggested but still remains controversial. Our working hypothesis is that methylprednisolone pulses and tacrolimus may be an effective and safety drug combination for treating severe COVID-19 patients. METHODS: and analysis: TACROVID is a randomized, open-label, single-center, phase II trial to evaluate the efficacy and safety of methylprednisolone pulses and tacrolimus plus standard of care (SoC) versus SoC alone, in patients at advanced stage of COVID-19 disease with lung injury and systemic hyperinflammatory response. Patients are randomly assigned (1:1) to one of two arms (42 patients in each group). The primary aim is to assess the time to clinical stability after initiating randomization. Clinical stability is defined as body temperature ≤37.5 °C, and PaO2/FiO2 > 400 and/or SatO2/FiO2 > 300, and respiratory rate ≤24 rpm; for 48 consecutive hours. DISCUSSION: Methylprednisolone and tacrolimus might be beneficial to treat those COVID-19 patients progressing into severe pulmonary failure and systemic hyperinflammatory syndrome. The rationale for its use is the fast effect of methylprednisolone pulses and the ability of tacrolimus to inhibit both the CoV-2 replication and the secondary cytokine storm. Interestingly, both drugs are low-cost and can be manufactured on a large scale; thus, if effective and safe, a large number of patients could be treated in developed and developing countries. TRIAL REGISTRATION NUMBER: NCT04341038 / EudraCT: 2020-001445-39.