Outcome of COVID-19 patients with haematological malignancies after the introduction of vaccination and monoclonal antibodies: results from the HM-COV 2.0 study (preprint)

Purpose. Patients with hematological malignancies (HM) and SARS-CoV-2 infection present a higher risk of severe COVID-19 and mortality. The aim of the study was to investigate whether vaccination and monoclonal antibodies (mAbs) have modified the outcomes of HM patients with COVID-19. Methods. Single-center retrospective study in HM patients hospitalized due to SARS-CoV-2 infection from March 2020 to April 2022. Patients were divided into PRE-V-mAb group (patients hospitalized before the introduction of vaccination and mAbs) and POST-V-mAb group (patients hospitalized after the use of vaccine and mAbs). Results. A total of 126 patients were included (65 PRE-V-mAb and 61 POST-V-mAb). POST-V-mAb patients showed a significantly lower risk of Intensive Care Unit (ICU) admission (8.2% vs 27.7%, p=0.005), shorter viral shedding [17 (IQR 10-28) vs 24 days (IQR 15-50), p=0.011] and shorter hospitalization length [13 (IQR 7-23) vs 20 (IQR 14-41) days, p=0.0003] compared to the PRE-V-mAb group. Nevertheless, both in-hospital and 30-day mortality rates did not significantly differ between the two groups (29.5% POST-V-mAb vs 36.9% PRE-V-mAb and 21.3% POST-V-mAb vs 29.2% PRE-V-mAb, respectively). At the multivariable analysis an active malignancy (p=0.042), a critical COVID-19 at admission (p=0.025) and the need for high-level of oxygen support at respiratory worsening [either HFNC/CPAP (p=0.022) or Mechanical Ventilation (p=0.011)] were independently associated with in-hospital mortality. In the subgroup of POST-V-mAb patients, receiving therapy with mAbs was a protective factor (p=0.033). Conclusion. Despite the new therapeutic and preventive strategies available, HM patients with COVID-19 disease represent an extremely vulnerable group with still high mortality rates.

Efficacy of remdesivir-containing therapy in hospitalized COVID-19 patients: a prospective clinical experience (preprint)

ABSTRACT Objectives remdesivir is currently approved for the treatment of COVID-19. The recommendation for using remdesivir in COVID-19 was based on the in vitro and in vivo activity of this drug against SARS-CoV-2. Methods this was a prospective, observational study conducted on a large population of patients hospitalized for COVID-19. The primary endpoint of the study was to evaluate the impact of remdesivir-containing therapy on 30-day mortality; secondary endpoint was the impact of remdesivir-containing therapy on the need of high flow oxygen therapy (HFNC) or non-invasive ventilation (NIV) or mechanical ventilation. Data were analyzed after propensity score matching. Results 407 patients with SARS-CoV-2 pneumonia were consecutively enrolled. Out of these, 294 (72.2%) and 113 (27.8%) were respectively treated or not with remdesivir. Overall, 61 (14.9%) patients were treated during hospitalization with non-invasive or mechanical ventilation, while a 30-day mortality was observed in 21 (5.2%) patients with a global in-hospital mortality of 11%. Cox regression analysis, after propensity score matching, showed that therapies, including remdesivir-containing therapy, were not statistically associated with 30-day survival or mortality, while need of HFNC/NIV (HR 17.921, CI95% 0.954-336.73, p=0.044) and mechanical ventilation (HR 3.9, CI95% 5.36-16.2, p=0.003) resulted independently associated with 30-day mortality. Finally, therapies including or not remdesivir were not independently associated with a lower or higher risk of HFNC/NIV or mechanical ventilation. Conclusions this real-life experience about the remdesivir use in hospitalized patients with COVID-19 was not associated with significant increase in rates of survival or reduced use of HFNC/NIV or mechanical ventilation, compared to patients treated with other therapies not including remdesivir.

Antiphospholipid Antibodies in Patients with Covid-19: Trend Over Time (preprint)

Purpose Aim of the study was to investigate whether aPL positivity correlated with thrombosis in COVID-19 patients and whether it was transient or persistent. Methods We enrolled COVID-19 patients who underwent aPL tests: Lupus Anticoagulant (LA); IgM, IgG, IgA anticardiolipin antibodies (aCL); and IgM, IgG anti-β2-Glycoprotein-I antibodies (aβ2GPI). Results Twenty-eight out of 73 (38.4%) patients resulted positive for at least one aPL assay: 32.8% for IgA aCL, 6.8% for IgM aCL and 4.1% for IgM aβ2GPI. No patients tested positive for IgG aPL or LA at the first determination. Seven (9.6%) patients developed thrombotic events during hospitalization, with 4 of them resulting positive for aPL. In patients with thrombotic events during hospitalization the risk of death was increased 9-fold (LR+8.9, p=0.003). Patients with double positivity for aCL and aβ2GPI IgM had a LR+ of 6.3 to have thrombotic events (p=0.012) and a LR+ of 4.9 to have elevated D-dimer levels (p=0.027). In 10 out of 28 positive patients, aPL was detected in a second occasion at least 12-weeks apart and two patients confirmed the positivity. Conclusion Results suggest that double positivity for aCL and aβ2GPI IgM increases the risk of thrombosis in COVID-19, unlike IgA aCL positivity. APL positivity may be persistent, and it is advisable to monitor it over time.

Retinal involvement and ocular findings in COVID‐19 pneumonia patients (preprint)

Background: changes in immune and coagulation systems and possible viral spread through blood-brain barrier have been described in SARS-CoV-2 infection. In this study, we evaluate the possible retinal involvement and ocular findings in severe COVID-19 pneumonia patients. Methods: a cross sectional study was conducted on 46 patients affected by severe COVID-19 who were hospitalized in one Intensive Care Unit (ICU) and in two Infectious Diseases wards, including a bedside eye screening, corneal sensitivity assessment and retinography. Results: a total of 43 SARS-CoV-2 positive pneumonia patients affected with COVID-19 pneumonia were included, 25 males and 18 females, with a median age of 70 [IQR 59-78]. Except for one patient with unilateral posterior chorioretinitis of opportunistic origin, of whom aqueous tap was negative for SARS-CoV-2, no further retinal manifestation related to COVID-19 infection was found in our cohort. We found 3 patients (7%) with bilateral conjunctivitis in whom PCR analysis on conjunctival swab provided negative results for SARS-CoV-2. No alterations of corneal sensitivity were found. Conclusion: we demonstrated the absence of retinal involvement in SARS-CoV-2 pneumonia patients. Ophthalmologic evaluation in COVID-19, particularly in patients hospitalized in an ICU setting, may be useful to reveal systemic co-infections by opportunistic pathogens.