Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities.

INTRODUCTION: Ropeginterferon alfa-2b represents a new-generation PEGylated interferon. It is approved for the treatment of polycythemia vera and shows promising anti-SARS-CoV-2 activities. OBJECTIVE: This clinical study aims to evaluate the efficacy and safety of ropeginterferon alfa-2b in patients with coronavirus disease 2019 (COVID-19) and comorbidities. METHODS: The randomized controlled study is designed to enroll adult patients with COVID-19 infection and comorbidities. Patients are non-responders to anti-SARS-CoV-2 drugs or not suitable to receive them. Comorbidities include hematologic cancer, solid tumor, and well-controlled autoimmune disease. Non-responders to anti-SARS-CoV-2 drugs are defined as having received treatment but have a Ct value < 30 at 14 days after symptom onset. Patients are randomized in a 1:1 ratio to receive ropeginterferon alfa-2b at 250 µg plus standard of care (SOC) or SOC alone. SARS-CoV-2 antigen test will be conducted at day 15 and day 29 visits to determine whether to administer additional ropeginterferon alfa-2b doses. Patients who are positive on the antigen test on days 15 and 29 will receive the second and third doses of ropeginterferon alfa-2b at 350 µg and 500 µg, respectively. Patients with a negative antigen test but a Ct value < 30 by reverse transcription polymerase chain reaction (RT-PCR) at days 15 and 29 are also administered the second (350 µg) and third (500 µg) doses. Patients at high risk of COVID-19 rebound/relapse, e.g., immunocompromised patients, will be given additional ropeginterferon alfa-2b doses even if the Ct is ≥ 30. Approximately 60 patients will be enrolled. PLANNED OUTCOMES: The primary outcome is to compare the time from randomization to the achievement of Ct value ≥ 30 by RT-PCR between ropeginterferon alfa-2b and control groups. Our previous studies have shown safety and promising anti-SARS-CoV-2 activities in patients with moderate or severe COVID-19. This study will provide valuable data in patients with COVID-19 and comorbidities, for whom safe and effective treatment is urgently needed. TRIAL REGISTRATION NUMBER: This trial is registered at ClinicalTrials.gov (Identifier NCT05808322).

Analysis of the clinical effect of noninvasive mechanical ventilation in AIDS patients complicated with pneumonia.

OBJECTIVE: To explore the clinical application effect of noninvasive mechanical ventilation for patients with acquired immune deficiency syndrome (AIDS) complicated with pneumonia. METHODS: A prospective study was conducted on 86 patients with AIDS complicated with pneumocystis pneumonia. The patients were randomly divided into a control group and an experimental group, both of which were treated with conventional drugs. The control group was supplemented with oxygen via a mask, and the experimental group was additionally treated with noninvasive ventilator ventilation. The changes of arterial oxygen partial pressure, oxygenation index, respiratory frequency, pulse rate, serum albumin and other indicators between the two groups before and after treatment were observed. The patient's hospitalization time, overall improvement and mortality rate were compared. RESULTS: Compared with those before treatment, the arterial oxygen partial pressure, oxygenation index, respiratory frequency, and pulse rate of the two groups of patients were significantly improved after treatment (P<0.05). The improvement of the experimental group after treatment was more significant than that of the control group, and the difference was statistically significant (P<0.001). After treatment, the proportion of recovery rate of serum albumin in the experimental group was 81.40%, which was significantly higher than that in the control group (53.49%), and the difference was statistically significant (P<0.05). Compared with the control group, hospitalization time, treatment improvement and mortality rate in the experimental group had significant advantages and statistical significance (P<0.05). CONCLUSION: For AIDS patients complicated with pneumonia, noninvasive mechanical ventilation had obvious treatment effects, which could significantly improve respiratory function, reduce mortality rate, and increase recovery rate. It can be considered as a therapeutic method to be included in routine treatment protocols.

Antithrombotic therapies for elderly patients: handling problems originating from their comorbidities.

Compared with younger people, elderly people have higher risks for both thrombosis and bleeding. Furthermore, comorbidities frequently found in elderly patients complicate the management of antithrombotic therapy. Thus, when treating these patients, physicians often find it difficult to incorporate the principles of evidence-based medicine and must determine the best treatment option for each patient. Recently, in the fields of cerebrovascular and cardiovascular diseases, researchers have been rapidly accumulating new data regarding antithrombotic therapy, particularly in the areas of direct oral anticoagulants (DOACs) and dual antiplatelet therapy (DAPT). However, information related to elderly patients receiving antithrombotic therapy is still relatively limited. There are also more and more publications describing how antithrombotic therapy affects the pathogenesis of non-thrombotic diseases. Similarly, the number of reports concerning adherence to this therapy has been increasing lately. However, no review articles detailing these findings have yet been published. In actual clinical practice, antithrombotic therapy in the elderly is not a treatment strategy targeted to only one organ or disease. Rather, it requires an interdisciplinary approach aimed at maintaining the overall health of the patient. Thus, to assist physicians' decision-making processes for elderly patients, an overview of recent findings related to the evidence regarding concomitant medications, the secondary benefits of antithrombotic therapy for patients with comorbidities, and evidence regarding medication adherence is provided.