Special Issue "Clinical Trends and Therapies of the COVID-19 Pandemic"

A special issue of Journal of Clinical Medicine (ISSN 2077-0383). This special issue belongs to the section "Infectious Diseases".

Deadline for manuscript submissions: 31 August 2021.

Special Issue Editors

Dr. Emanuele Nicastri
E-Mail Website
Guest Editor
National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, Rome, Italy
Interests: infectious diseases; emerging and remerging infectious diseases; tropical sisease; virology; pharmaco epidemiology; clinical trials
Dr. Simone Lanini
E-Mail Website
Guest Editor
National Institute for Infectious Diseases Lazzaro Spallanzani-IRCCS, 00149 Rome, Italy
Interests: infectious diseases; epidemiology; cross infections; hospital outbreak; clinical trial

Special Issue Information

Dear Colleagues,

The ongoing pandemic of coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was first identified in December 2019 in Wuhan, China.

Since then, research has come a long way, but several areas are still poorly defined. In particular, there are still significant uncertainties about the primary natural reservoir of the ancestor of the coronavirus strain that eventually produced the human spillover. In addition, the transmission of SARS-CoV-2 among human beings has produced novel epidemic scenarios whose local evolutions are still poorly understood.

Although the pandemic is spreading globally, the subsequent waves of the epidemic have been uneven across the geographic areas and different population groups. Indeed, current predictive models are still too weak to produce a reliable estimation about the role of several pivotal factors associated with the intensity of the epidemic and with the case–fatality rate of the diseases.

Moreover, while old medical practices have already been revised to optimize COVID-19 therapy by using current tools (e.g., steroids, heparin and oxygen therapy), the breathtaking efforts in the field of drug research and development is finally starting to bear fruit.

In the upcoming year, several new compounds will be licensed, including new vaccines, monoclonal antibodies against SARS-CoV-2, new antivirals and potentially a series of refurbished immune modulants.

The clinical impact of these all these new strategies is the primary objective of this Special Issue.

Dr. Emanuele Nicastri
Dr. Simone Lanini
Guest Editors

Manuscript Submission Information

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Keywords

  • COVID-19
  • SARS-CoV2
  • therapies
  • monoclonal antibody
  • clinical trials
  • longitudinal Cohort

Published Papers (7 papers)

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Research

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Article
Outcomes and Timing of Bedside Percutaneous Tracheostomy of COVID-19 Patients over a Year in the Intensive Care Unit
J. Clin. Med. 2021, 10(15), 3335; https://doi.org/10.3390/jcm10153335 (registering DOI) - 28 Jul 2021
Abstract
Background: The benefits and timing of percutaneous dilatational tracheostomy (PDT) in Intensive Care Unit (ICU) COVID-19 patients are still controversial. PDT is considered a high-risk procedure for the transmission of SARS-CoV-2 to healthcare workers (HCWs). The present study analyzed the optimal timing of [...] Read more.
Background: The benefits and timing of percutaneous dilatational tracheostomy (PDT) in Intensive Care Unit (ICU) COVID-19 patients are still controversial. PDT is considered a high-risk procedure for the transmission of SARS-CoV-2 to healthcare workers (HCWs). The present study analyzed the optimal timing of PDT, the clinical outcomes of patients undergoing PDT, and the safety of HCWs performing PDT. Methods: Of the 133 COVID-19 patients who underwent PDT in our ICU from 1 April 2020 to 31 March 2021, 13 patients were excluded, and 120 patients were enrolled. A trained medical team was dedicated to the PDT procedure. Demographic, clinical history, and outcome data were collected. Patients who underwent PDT were stratified into two groups: an early group (PDT ≤ 12 days after orotracheal intubation (OTI) and a late group (>12 days after OTI). An HCW surveillance program was also performed. Results: The early group included 61 patients and the late group included 59 patients. The early group patients had a shorter ICU length of stay and fewer days of mechanical ventilation than the late group (p < 0.001). On day 7 after tracheostomy, early group patients required fewer intravenous anesthetic drugs and experienced an improvement of the ventilation parameters PaO2/FiO2 ratio, PEEP, and FiO2 (p < 0.001). No difference in the case fatality ratio between the two groups was observed. No SARS-CoV-2 infections were reported in the HCWs performing the PDTs. Conclusions: PDT was safe and effective for COVID-19 patients since it improved respiratory support parameters, reduced ICU length of stay and duration of mechanical ventilation, and optimized the weaning process. The procedure was safe for all HCWs involved in the dedicated medical team. The development of standardized early PDT protocols should be implemented, and PDT could be considered a first-line approach in ICU COVID-19 patients requiring prolonged mechanical ventilation. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)
Article
Benefits of Steroid Therapy in COVID-19 Patients with Different PaO2/FiO2 Ratio at Admission
J. Clin. Med. 2021, 10(15), 3236; https://doi.org/10.3390/jcm10153236 - 22 Jul 2021
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Abstract
Introduction: The use of steroid therapy in patients within the context of SARS-CoV-2 infection is still a matter of debate. This study aimed to evaluate if potential steroid benefits could be predicted by the ratio of arterial oxygen partial pressure (PaO2 in [...] Read more.
Introduction: The use of steroid therapy in patients within the context of SARS-CoV-2 infection is still a matter of debate. This study aimed to evaluate if potential steroid benefits could be predicted by the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) (P/F) in COVID-19 patients at admission. Materials and Methods: Medical records were retrospectively collected from all adult patients admitted because of COVID-19 from 29 January to 31 July 2020. The association of steroid therapy with 28-day all-cause mortality outcome was analysed in a multivariable logistic regression model adjusted for confounding factors. Results: Overall, 511 patients were analysed, of which 39.1% underwent steroid therapy. Steroid treated patients were mostly male, older, and more frequently treated with antiviral drugs and aminoquinolines; the most common comorbidities were hypertension, followed by cardiovascular disease. Overall, 51 patients died within 28-days, and overall 28-days mortality was 19.5% in the cohort of patients exposed to steroids versus 3.9% mortality in unexposed patients (p < 0.001). Steroid therapy on patients with P/F ratio of 235 mmHg or higher at admission can be considered as detrimental, with an 8% increased probability of death. Conclusions: Steroid therapy is associated with increased 28-day mortality in COVID-19 in patients with mild or no ARDS. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)
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Article
Importance of Lung Ultrasound Follow-Up in Patients Who Had Recovered from Coronavirus Disease 2019: Results from a Prospective Study
J. Clin. Med. 2021, 10(14), 3196; https://doi.org/10.3390/jcm10143196 - 20 Jul 2021
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Abstract
There is growing evidence regarding the imaging findings of coronavirus disease 2019 (COVID-19) in lung ultrasounds, however, their role in predicting the prognosis has yet to be explored. Our objective was to assess the usefulness of lung ultrasound in the short-term follow-up (1 [...] Read more.
There is growing evidence regarding the imaging findings of coronavirus disease 2019 (COVID-19) in lung ultrasounds, however, their role in predicting the prognosis has yet to be explored. Our objective was to assess the usefulness of lung ultrasound in the short-term follow-up (1 and 3 months) of patients with SARS-CoV-2 pneumonia, and to describe the progression of the most relevant lung ultrasound findings. We conducted a prospective, longitudinal and observational study performed in patients with confirmed COVID-19 who underwent a lung ultrasound examination during hospitalization and repeated it 1 and 3 months after hospital discharge. A total of 96 patients were enrolled. In the initial ultrasound, bilateral involvement was present in 100% of the patients with mild, moderate or severe ARDS. The most affected lung area was the posteroinferior (93.8%) followed by the lateral (88.7%). Subpleural consolidations were present in 68% of the patients and consolidations larger than 1 cm in 24%. One month after the initial study, only 20.8% had complete resolution on lung ultrasound. This percentage rose to 68.7% at 3 months. Residual lesions were observed in a significant percentage of patients who recovered from moderate or severe ARDS (32.4% and 61.5%, respectively). In conclusion, lung injury associated with COVID-19 might take time to resolve. The findings in this report support the use of lung ultrasound in the short-term follow-up of patients recovered from COVID-19, as a radiation-sparing, easy to use, novel care path worth exploring. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)
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Article
Long-Term Outcomes of Patients with Coronavirus Disease 2019 at One Year after Hospital Discharge
J. Clin. Med. 2021, 10(13), 2945; https://doi.org/10.3390/jcm10132945 - 30 Jun 2021
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Abstract
Background: The long-term effects of COVID-19 remain largely unclear. This study aims to investigate post-acute health consequences and mortality one year after hospital discharge. Methods: All surviving adult patients who were discharged after hospital admission due to acute COVID-19 in the first wave [...] Read more.
Background: The long-term effects of COVID-19 remain largely unclear. This study aims to investigate post-acute health consequences and mortality one year after hospital discharge. Methods: All surviving adult patients who were discharged after hospital admission due to acute COVID-19 in the first wave of the pandemic underwent a comprehensive interview. Functional assessment was performed in patients aged over 65. Clinical and hospital records were reviewed and mortality causes assessed. Results: A total of 587 patients with COVID-19 were discharged from hospital, including 266 after hospital admission and 321 from the emergency room. Mortality within the following year occurred in 34/266 (12.8%) and 10/321 (3.1%), respectively, due to causes directly or possibly related to COVID-19 in 20.5% and 25% of patients. Post-COVID-19 syndrome was assessed in 543 patients at one year from discharge. Any clinical complaint was reported by 90.1% of patients who needed hospitalization and 80.4% of those discharged from the emergency room (p = 0.002), with breathlessness (41.6%), tiredness (35.4%), ageusia (30.2%), and anosmia (26.3%) being the most common complaints. Ongoing symptoms attributed to COVID-19 were reported by 66.8% and 49.5% of patients, respectively (p < 0.001). Newly developed COPD, asthma, diabetes, heart failure, and arthritis—as well as worsening of preexisting comorbidities—were found. Conclusions: One-year mortality among survivors of acute COVID-19 was 7.5%. A significant proportion of COVID-19 patients experienced ongoing symptoms at 1 year from onset of the disease. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)
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Article
Risk Factors for Mortality in COVID-19 Hospitalized Patients in Piedmont, Italy: Results from the Multicenter, Regional, CORACLE Registry
J. Clin. Med. 2021, 10(9), 1951; https://doi.org/10.3390/jcm10091951 - 01 May 2021
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Abstract
Background: CORACLE is a retrospective and prospective, regional multicenter registry, developed to evaluate risk factors for mortality in a cohort of patients admitted with SARS-CoV-2 infection within non-intensive wards. Methods: The primary objective was to estimate the role of several prognostic factors on [...] Read more.
Background: CORACLE is a retrospective and prospective, regional multicenter registry, developed to evaluate risk factors for mortality in a cohort of patients admitted with SARS-CoV-2 infection within non-intensive wards. Methods: The primary objective was to estimate the role of several prognostic factors on hospital mortality in terms of adjusted Odds Ratios (aOR) with multivariable logistic regression models. Results: A total of 1538 patients were enrolled; 42% were female, and 58% were >70 years old. Deceased patients were 422 (27%), with a median age of 83 years (IQR (Inter Quartile Range) 76–87). Older age at admission (aOR 1.07 per year, 95%CI 1.06–1.09), diabetes (1.41, 1.02–1.94), cardiovascular disease (1.79, 1.31–2.44), immunosuppression (1.65, 1.04–2.62), estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 (3.53, 2.26–5.51), higher C-reactive protein values and a decreased PaO2/FiO2 ratio at admission were associated with a higher risk of hospital mortality. Amongst patients still alive on day 7, only hydroxychloroquine (HCQ) treatment was associated with reduced mortality (0.57, 0.36–0.90). Conclusions: Several risk factors were associated with mortality in SARS-CoV-2 positive patients. Although HCQ seems to be the only factor significantly associated with reduced mortality, this result is in contrast with evidence from randomized studies. These results should be interpreted in light of the study limitations. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)

Review

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Review
Calprotectin, an Emerging Biomarker of Interest in COVID-19: A Systematic Review and Meta-Analysis
J. Clin. Med. 2021, 10(4), 775; https://doi.org/10.3390/jcm10040775 - 15 Feb 2021
Cited by 1 | Viewed by 1259
Abstract
COVID-19 has been shown to present with varied clinical course, necessitating a need for more specific diagnostic tools that could identify severe cases and predict outcomes during COVID-19 infection. Recent evidence has shown an expanded potential role for calprotectin, both as a diagnostic [...] Read more.
COVID-19 has been shown to present with varied clinical course, necessitating a need for more specific diagnostic tools that could identify severe cases and predict outcomes during COVID-19 infection. Recent evidence has shown an expanded potential role for calprotectin, both as a diagnostic tool and also as a tool in stratifying COVID-19 patients in terms of severity. Therefore, this systematic review and meta-analysis aims to evaluate the levels of calprotectin in severe and non-severe COVID-19 and also identify the implication of raised calprotectin levels. MEDLINE, EMBASE, The Cochrane Library, Web of science and MedRxiv were searched. Meta-analysis was done to compare the serum/fecal levels of calprotectin between severe and non-severe COVID-19 infections. A total of ten studies included in the review (eight had quantitative data while two were qualitative). A pooled analysis of the eight studies from 613 patients who were RT-PCR positive for COVID-19 (average age = 55 years; 52% males) showed an overall estimate as 1.34 (95%CI: 0.77, 1.91). In conclusion, calprotectin levels have been demonstrated to be significantly elevated in COVID-19 patients who develop the severe form of the disease, and it also has prognostic importance. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)
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Brief Report
Direct and Indirect Impact of COVID-19 for Patients with Immune-Mediated Inflammatory Diseases: A Retrospective Cohort Study
J. Clin. Med. 2021, 10(11), 2388; https://doi.org/10.3390/jcm10112388 - 28 May 2021
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Abstract
Importance: Since the beginning of the Coronavirus Disease-19 (COVID-19) pandemic, Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection has been a serious challenge for immune-compromised patients with immune-mediated inflammatory diseases (IMIDs). Objective: Our aim was to investigate the impact of COVID-19 in terms of risks [...] Read more.
Importance: Since the beginning of the Coronavirus Disease-19 (COVID-19) pandemic, Severe Acute Respiratory Syndrome-CoV-2 (SARS-CoV-2) infection has been a serious challenge for immune-compromised patients with immune-mediated inflammatory diseases (IMIDs). Objective: Our aim was to investigate the impact of COVID-19 in terms of risks of infection, hospitalization and mortality in a cohort of patients with rheumatoid arthritis (RA), psoriasis (PSO) or inflammatory bowel disease (IBD). Furthermore, we studied the impact of SARS-CoV-2 infection on the prescribed drug regimen in these patients. Methods: Through the record linkage between health information systems, a cohort of patients, ≥18 years old, assisted in the Lazio region and who had suffered from immune-mediated inflammatory diseases (RA, PSO, IBD) between 2007 and 2019, was identified. The risk of infection, hospitalization or mortality for COVID-19, was assessed by logistic regression models, and reported in an Odds Ratio (ORs; CI 95%), adjusting for sex, age and the Charlson Comorbidity Index. We also estimated these risks separately by IMID and in the subgroup of prevalent biologic drug users. We investigated deferral of biological treatments in the study population by comparing the prevalence of weekly use of biologicals (2019–2020) before and during the pandemic periods. Findings: Within the 65,230 patients with IMIDs, the cumulative incidence for COVID-19 was 303/10,000 ab. In this cohort of patients, we observed a significantly higher risk of SARS-CoV-2 infection than the general population: OR = 1.17 (95% CI 1.12–1.22). The risk was higher even considering separately each disease and in the subgroup of prevalent biologic drug users. This last subgroup of patients showed a higher risk of death related to COVID-19 (OR 1.89; 95% CI 1.04–3.33) than the general population. However, no differences in terms of risks of hospitalization or death related to COVID-19 were recorded in patients with the IMIDs. Comparing the 2019–2020 prevalence of weekly biological drug treatments in prevalent biologic drug users, we found a decrease (−19.6%) during the lockdown, probably due to pandemic restrictions. Conclusions and Relevance: Patients with IMIDs seem to have a higher risk of SARS-CoV2 infection. However, other than for patients with prevalent biologic drug treatment, no significant differences in terms of hospitalization and mortality were reported compared to the general populations; further investigation is warranted on account of unmeasured confounding. In addition, during the lockdown period, the COVID-19 emergency highlighted a lower use of biologic drugs; this phenomenon requires strict pharmacological monitoring as it could be a proxy of forthcoming long-term clinical progression. Full article
(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)
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