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Clinical Trends and Therapies of the COVID-19 Pandemic

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

Deadline for manuscript submissions: closed (30 November 2023) | Viewed by 39410

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Dr. Emanuele Nicastri

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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

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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

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Keywords

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

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Published Papers (9 papers)

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Research

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21 pages, 3107 KiB

Open AccessArticle

COVID-19 Salivary Protein Profile: Unravelling Molecular Aspects of SARS-CoV-2 Infection

by Eduardo Esteves, Vera M. Mendes, Bruno Manadas, Rafaela Lopes, Liliana Bernardino, Maria José Correia, Marlene Barros, Ana Cristina Esteves and Nuno Rosa

J. Clin. Med. 2022, 11(19), 5571; https://doi.org/10.3390/jcm11195571 - 22 Sep 2022

Cited by 5 | Viewed by 2815

Abstract

COVID-19 is the most impacting global pandemic of all time, with over 600 million infected and 6.5 million deaths worldwide, in addition to an unprecedented economic impact. Despite the many advances in scientific knowledge about the disease, much remains to be clarified about the molecular alterations induced by SARS-CoV-2 infection. In this work, we present a hybrid proteomics and in silico interactomics strategy to establish a COVID-19 salivary protein profile. Data are available via ProteomeXchange with identifier PXD036571. The differential proteome was narrowed down by the Partial Least-Squares Discriminant Analysis and enrichment analysis was performed with FunRich. In parallel, OralInt was used to determine interspecies Protein-Protein Interactions between humans and SARS-CoV-2. Five dysregulated biological processes were identified in the COVID-19 proteome profile: Apoptosis, Energy Pathways, Immune Response, Protein Metabolism and Transport. We identified 10 proteins (KLK 11, IMPA2, ANXA7, PLP2, IGLV2-11, IGHV3-43D, IGKV2-24, TMEM165, VSIG10 and PHB2) that had never been associated with SARS-CoV-2 infection, representing new evidence of the impact of COVID-19. Interactomics analysis showed viral influence on the host immune response, mainly through interaction with the degranulation of neutrophils. The virus alters the host’s energy metabolism and interferes with apoptosis mechanisms. Full article

(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)

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8 pages, 575 KiB

Open AccessArticle

Changes in the Mean and Variance of the Numbers of Medical Visits for Allergic Diseases before and during the COVID-19 Pandemic in Korea

by Hyo Geun Choi, Joo-Hee Kim, Yong-Hwi An, Min Woo Park and Jee Hye Wee

J. Clin. Med. 2022, 11(15), 4266; https://doi.org/10.3390/jcm11154266 - 22 Jul 2022

Cited by 4 | Viewed by 1660

Abstract

The implementation of precautionary measures, such as wearing a mask and social distancing, may have affected allergic diseases during the coronavirus disease 2019 (COVID-19) pandemic. This study aimed to compare the numbers of medical visits for allergic diseases before and during the COVID-19 pandemic. Data were obtained from the Korean National Health Insurance claims database. Monthly numbers of patients for four allergic diseases, i.e., allergic rhinitis (AR), asthma, atopic dermatitis (AD), and allergic conjunctivitis (AC), were evaluated using ICD-10 codes and compared between the ‘before COVID-19’ period from January 2018 to February 2020, and the ‘during COVID-19’ period from March 2020 to June 2021, since the first COVID-19 patient was detected on 20 January 2020, in Korea. Subgroup analyses were performed according to age and sex. The mean numbers of medical visits for AR and asthma were significantly greater before COVID-19 than those during COVID-19 (both p < 0.001). The variance in the number of medical visits for asthma decreased during the COVID-19 pandemic. However, the mean number of medical visits for AD increased slightly during COVID-19 and that for AC did not change before and during the COVID-19 pandemic. In subgroup analyses, the results showed a similar pattern to that of the total number of participants, regardless of age and sex. In conclusion, medical visits for AR and asthma significantly decreased during the COVID-19 pandemic, regardless of age and sex. Full article

(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)

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12 pages, 1354 KiB

Open AccessArticle

Management of Spontaneous Bleeding in COVID-19 Inpatients: Is Embolization Always Needed?

by Pascale Riu, Fabrizio Albarello, Federica Di Stefano, Alessandra Vergori, Alessandra D’Abramo, Carlo Cerini, Martina Nocioni, Maurizio Morucci, Nardi Tetaj, Massimo Cristofaro, Vincenzo Schininà, Paolo Campioni, Ada Petrone, Nicoletta Fusco, Luisa Marchioni, Andrea Antinori, Emanuele Nicastri, Roberto Cianni and Stefania Ianniello

J. Clin. Med. 2021, 10(18), 4119; https://doi.org/10.3390/jcm10184119 - 12 Sep 2021

Cited by 16 | Viewed by 3311

Abstract

Background: critically ill patients with SARS-CoV-2 infection present a hypercoagulable condition. Anticoagulant therapy is currently recommended to reduce thrombotic risk, leading to potentially severe complications like spontaneous bleeding (SB). Percutaneous transcatheter arterial embolization (PTAE) can be life-saving in critical patients, in addition to medical therapy. We report a major COVID-19 Italian Research Hospital experience during the pandemic, with particular focus on indications and technique of embolization. Methods: We retrospectively included all subjects with SB and with a microbiologically confirmed SARS-CoV-2 infection, over one year of pandemic, selecting two different groups: (a) patients treated with PTAE and medical therapy; (b) patients treated only with medical therapy. Computed tomography (CT) scan findings, clinical conditions, and biological findings were collected. Results: 21/1075 patients presented soft tissue SB with an incidence of 1.95%. 10/21 patients were treated with PTAE and medical therapy with a 30-days survival of 70%. Arterial blush, contrast late enhancement, and dimensions at CT scan were found discriminating for the embolization (p < 0.05). Conclusions: PTAE is an important tool in severely ill, bleeding COVID-19 patients. The decision for PTAE of COVID-19 patients must be carefully weighted with particular attention paid to the clinical and biological condition, hematoma location and volume. Full article

(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)

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9 pages, 546 KiB

Open AccessArticle

The Effects of Previous Thyroid Disease on the Susceptibility to, Morbidity of, and Mortality Due to COVID-19: A Nationwide Cohort Study in South Korea

by So-Young Kim, Dae-Myoung Yoo, Chan-Yang Min and Hyo-Geun Choi

J. Clin. Med. 2021, 10(16), 3522; https://doi.org/10.3390/jcm10163522 - 11 Aug 2021

Cited by 9 | Viewed by 2952

Abstract

This study aimed to investigate the associations of the susceptibility to, morbidity of, and mortality due to coronavirus disease 2019 (COVID-19) with thyroid diseases. Korea National Health Insurance Database Coronavirus disease 2019 (NHID-COVID-19) medical claim code data from 2015 to 2020 were analyzed. A total of 8070 COVID-19 patients and 32,280 matched control participants were evaluated for histories of hypothyroidism, hyperthyroidism, Graves’ disease, thyroiditis, and autoimmune thyroiditis. The relationships of susceptibility to, morbidity of, and mortality due to COVID-19 with hypothyroidism, hyperthyroidism, Graves’ disease, thyroiditis, and autoimmune thyroiditis were analyzed using a conditional logistic regression. Hypothyroidism, hyperthyroidism, Graves’ disease, thyroiditis, and autoimmune thyroiditis were not associated with susceptibility to, morbidity of, or mortality due to COVID-19. Graves’ disease was related to higher odds of mortality due to COVID-19 in the adjusted model but the confidence interval (CI) was wide, probably due to the small number of deaths among patients with Graves’ disease (aOR = 11.43, 95% CI = 1.29–101.22, p = 0.029). Previous histories of hypothyroidism, hyperthyroidism, Graves’ disease, thyroiditis, and autoimmune thyroiditis were not related to susceptibility to COVID-19. In addition, prior histories of thyroid diseases were not related to increased risks of COVID-19-related morbidity and mortality. Full article

(This article belongs to the Special Issue Clinical Trends and Therapies of the COVID-19 Pandemic)

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11 pages, 1002 KiB

Open AccessArticle

Importance of Lung Ultrasound Follow-Up in Patients Who Had Recovered from Coronavirus Disease 2019: Results from a Prospective Study

by Alba Hernández-Píriz, Yale Tung-Chen, David Jiménez-Virumbrales, Ibone Ayala-Larrañaga, Raquel Barba-Martín, Jesús Canora-Lebrato, Antonio Zapatero-Gaviria and Gonzalo García De Casasola-Sánchez

J. Clin. Med. 2021, 10(14), 3196; https://doi.org/10.3390/jcm10143196 - 20 Jul 2021

Cited by 19 | Viewed by 4941

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 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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15 pages, 830 KiB

Open AccessArticle

Long-Term Outcomes of Patients with Coronavirus Disease 2019 at One Year after Hospital Discharge

by Modesto M. Maestre-Muñiz, Ángel Arias, Emilia Mata-Vázquez, María Martín-Toledano, Germán López-Larramona, Ana María Ruiz-Chicote, Bárbara Nieto-Sandoval and Alfredo J. Lucendo

J. Clin. Med. 2021, 10(13), 2945; https://doi.org/10.3390/jcm10132945 - 30 Jun 2021

Cited by 119 | Viewed by 7779

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 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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13 pages, 306 KiB

Open AccessArticle

Risk Factors for Mortality in COVID-19 Hospitalized Patients in Piedmont, Italy: Results from the Multicenter, Regional, CORACLE Registry

by Francesco Giuseppe De Rosa, Annagloria Palazzo, Tiziana Rosso, Nour Shbaklo, Marco Mussa, Lucio Boglione, Enrica Borgogno, Antonella Rossati, Simone Mornese Pinna, Silvia Scabini, Guido Chichino, Silvio Borrè, Valerio Del Bono, Pietro Luigi Garavelli, Diego Barillà, Francesco Cattel, Giovanni Di Perri, Giovannino Ciccone, Tommaso Lupia and Silvia Corcione

J. Clin. Med. 2021, 10(9), 1951; https://doi.org/10.3390/jcm10091951 - 1 May 2021

Cited by 16 | Viewed by 4697

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 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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14 pages, 1142 KiB

Open AccessReview

Calprotectin, an Emerging Biomarker of Interest in COVID-19: A Systematic Review and Meta-Analysis

by Raphael Udeh, Shailesh Advani, Luis García de Guadiana Romualdo and Xenia Dolja-Gore

J. Clin. Med. 2021, 10(4), 775; https://doi.org/10.3390/jcm10040775 - 15 Feb 2021

Cited by 38 | Viewed by 5420

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 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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7 pages, 1609 KiB

Open AccessBrief Report

Direct and Indirect Impact of COVID-19 for Patients with Immune-Mediated Inflammatory Diseases: A Retrospective Cohort Study

by Valeria Belleudi, Alessandro C. Rosa, Francesca R. Poggi, Alessandro Armuzzi, Emanuele Nicastri, Delia Goletti, Andrea Picchianti Diamanti, Marina Davoli, Nera Agabiti and Antonio Addis

J. Clin. Med. 2021, 10(11), 2388; https://doi.org/10.3390/jcm10112388 - 28 May 2021

Cited by 18 | Viewed by 3537

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 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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