Faculty of Medicine

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Efficacy and Safety of COVID-19 Convalescent Plasma in Hospitalized Patients-An Open-Label Phase II Clinical Trial
(MDPI (Multidisciplinary Digital Publishing Institute), 2022-10-09)
Grubovic Rastvorceva Rada
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Sedula Useini
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Background: COVID-19 convalescent plasma (CCP) is an important antiviral option for selected patients with COVID-19. Materials and Methods: In this open-label, phase 2, clinical trial conducted from 30 April 2020 till 10 May 2021 in the Republic of North Macedonia, we evaluated the efficacy and safety of CCP in hospitalized patients. Treatment was with a single unit of CCP having an anti-RBD IgG concentration higher than 5 AU/mL. Results: There were 189 patients that completed the study, of which 65 (34.4%) had WHO 8-point clinical progression scale score of 3 (requiring hospital care but not oxygen support), 65 (34.4%) had a score of 4 (hospitalized and requiring supplemental oxygen by mask or nasal prongs), and 59 (31.2%) had a score of 5 (hospitalized and requiring supplemental oxygen by non-invasive ventilation or high-flow oxygen). Mean age was 57 years (range 22−94), 78.5% were males, 80.4% had elevated body mass index, and 70.9% had comorbidity. Following CCP transfusion, we observed clinical improvement with increase rates in oxygenation-free days of 32.3% and 58.5% at 24 h and seven days after CCP transfusion, a decline in WHO scores, and reduced progression to severe disease (only one patient was admitted to ICU after CCP transfusion). Mortality in the entire cohort was 11.6% (22/189). We recorded 0% mortality in WHO score 3 (0/65) and in patients that received CCP transfusion in the first seven days of disease, 4.6% mortality in WHO score 4 (3/65), and 30.5% mortality in WHO score 5 (18/59). Mortality correlated with WHO score (Chi-square 19.3, p < 0.001) and with stay in the ICU (Chi-square 55.526, p ≤ 0.001). No severe adverse events were reported. Conclusions: This study showed that early administration of CCP to patients with moderate disease was a safe and potentially effective treatment for hospitalized COVID-19 patients. The trial was registered at clinicaltrials.gov (NCT04397523).
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Complications of Coronavirus Disease-19 in a Hospitalized Patient: A Case Report
(Scientific Foundation Spiroski (publications), 2020-12-25)
Meshkova, Iskra
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Simeonova, Magdalena
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Markovska, Zorica
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Markoska, Vesna
BACKGROUND: Coronavirus (CoV) disease (COVID)-19 infection is a major public health issue worldwide with no specific therapy or vaccine. CASE REPORT: COVID-19-positive patient was hospitalized due to a dry irritating cough that has persisted for 3 days. The polymerase chain reaction test to severe acute respiratory syndrome-CoV-2 was positive. Computed tomography (CT) scan of the lungs showed massive bilateral consolidation. The patient was set to oxygen support (6 L/min). Two hours after referring the patient’s condition worsened with shortness of breath, suffocation, wheezing, and decreased saturation (77%). The patient was given mechanical support with continuous positive airway pressure mask. Therapy included azithromycin 500 mg and ceftriaxone 2 g. On the 3rd day of hospitalization, there was a sharp deterioration of the condition and a decrease in saturation (40%). The patient was intubated and immediately placed on intermittent positive pressure ventilation. Azithromycin was now combined with meropenem 3 × 1 g. The next morning patient’s condition further worsened with decrease in saturation and heart rate. The resuscitation was unsuccessful. CONCLUSION: COVID-19 is primary a respiratory infection, but the virus also affects other organs with poor outcome.
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Short‐ and long‐term outcome and predictors in an international cohort of patients with neuro‐COVID‐19
(Wiley, 2022-03-07)
Beghi, Ettore
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Helbok, Raimund
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Ozturk, Serefnur
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Karadas, Omer
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Lisnic, Vitalie
Background and purpose: Despite the increasing number of reports on the spectrum of neurological manifestations of COVID-19 (neuro-COVID), few studies have assessed short- and long-term outcome of the disease. Methods: This is a cohort study enrolling adult patients with neuro-COVID seen in neurological consultation. Data were collected prospectively or retrospectively in the European Academy of Neurology NEuro-covid ReGistrY ((ENERGY). The outcome at discharge was measured using the modified Rankin Scale and defined as 'stable/improved' if the modified Rankin Scale score was equal to or lower than the pre-morbid score, 'worse' if the score was higher than the pre-morbid score. Status at 6 months was also recorded. Demographic and clinical variables were assessed as predictors of outcome at discharge and 6 months. Results: From July 2020 to March 2021, 971 patients from 19 countries were included. 810 (83.4%) were hospitalized. 432 (53.3%) were discharged with worse functional status. Older age, stupor/coma, stroke and intensive care unit (ICU) admission were predictors of worse outcome at discharge. 132 (16.3%) died in hospital. Older age, cancer, cardiovascular complications, refractory shock, stupor/coma and ICU admission were associated with death. 262 were followed for 6 months. Acute stroke or ataxia, ICU admission and degree of functional impairment at discharge were predictors of worse outcome. 65/221 hospitalized patients (29.4%) and 10/32 non-hospitalized patients (24.4%) experienced persisting neurological symptoms/signs. 10/262 patients (3.8%) developed new neurological complaints during the 6 months of follow-up. Conclusions: Neuro-COVID is a severe disease associated with worse functional status at discharge, particularly in older subjects and those with comorbidities and acute complications of infection.
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CORTICOSTEROID RESPONSIVE COVID-19 ENCEPHALITIS - CASE REPORT
(SHMSHM - AAMD, 2024-12)
Atanasovski, Petar
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Zdravkov, Ilija
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Perovska, Marija
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The epidemiological burden of COVID-19 is a healthcare challenge reflected throughout the world. Different specialties are constantly confronted with unique cases that add to the array of Covid-19 symptoms. The neurological manifestations of SARS-CoV-2 infected patients are receiving increasing attention with the global spread of SARS-CoV-2. We present a novel case of SARS-CoV-2 associated acute encephalitis in a young adult without comorbidities and mild symptoms of infectious syndrome. The pathophysiological mechanism of acute encephalitis in COVID-19 is not well defined. There are two main hypotheses: a direct cytopathic effect of the infection of the brain tissue (the angiotensin-converting enzyme 2 receptors that the virus uses for attachment, margination, and internalization in the lung, are also expressed in the central nervous system; viral antigens were detected in CSF and brain samples), and an autoimmune/immunemediated cause (the general hyperinflammatory state releases cytokines and chemokines that impairs the bloodbrain barrier permeability and activate neuro-inflammatory cascades). In our case, the acute encephalitis induced by COVID-19 had a benign course, the patients improved quickly after IV steroids treatment and returned to their baseline state of health.
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PURPURA ANNULARIS TELANGIECTODES OF MAJOCCHI ASSOCIATED WITH THE USE OF DIETARY SUPPLEMENTS
(Българско дерматологично дружество, 2024)
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Damevska, Stefana
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Nordmann, Kim
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Maternal and perinatal outcomes in women with advanced maternal age affected by SARS-CoV-2 infection (Phase-2): The WAPM (World Association of Perinatal Medicine) Working Group on COVID-19
(Cetus Publishing, 2021-03-09)
D'Antonio, Francesco
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Şen, Cihat
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Di Mascio, Daniel
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Galindo, Alberto
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Villalain, Cecilia
Objective To elucidate the role of advanced maternal age (AMA) in determining the outcome of pregnancies complicated by SARS-CoV-2 infection. Methods Multinational cohort study included women with laboratory-confirmed SARS-CoV-2 infection from 76 centers in 27 different countries in Europe, United States, South America, Asia and Australia from 04 April 2020 till 28 October 2020. The primary outcome was a composite measure of maternal mortality and morbidity including admission to intensive care unit (ICU), use of mechanical ventilation (defined as intubation, need for continuous positive airway pressure, extra-corporeal membrane oxygenation), severe respiratory symptoms (including dyspnea and shortness of breath) or death. Results Eight hundred and eighty seven pregnant women were included in the study who were positive SARS-CoV-2 results by RT-PCR (reverse transcriptase-polymerase chain reaction) on their nasal and pharyngeal swab specimens (352 with and 652 with no AMA). The risk of composite adverse maternal outcome was higher in AMA group compared to that of under 35 years of age group, with an OR of 1.99 (95% CI 1.4–2.9; p=0.002). Likewise, women >35 years were also at higher risk of hospital admission (OR: 1.88, 95% CI 1.4–2.5; p<0.001), presence of severe respiratory symptoms (OR: 1.53, 95% CI 1.0–2.3; p=0.04) and/or admission to ICU (OR: 2.00, 95% CI 1.1–3.7; p=0.003); however, no difference was observed in terms of perinatal outcome risk. Conclusion Advanced maternal age is an independent risk factor for adverse maternal outcome in pregnancies complicated by SARS-CoV-2 infection. Accurate risk stratification of women presenting with suspected SARS-CoV-2 infection in pregnancy is warranted in order to identify a subset of women who may benefit from a personalized management, including elective hospitalization and/or prolonged surveillance in order to improve maternal outcome.
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Surgical complications in COVID-19 patients in the setting of moderate to severe disease
(Baishideng Publishing Group Inc., 2021-08-27)
Gulinac, Milena
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Novakov, Ivan P
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Velikova, Tsvetelina
The coronavirus disease 2019 (COVID-19) pandemic has had a considerable impact on the work of physicians and surgeons. The connection between the patient and the surgeon cannot be replaced by telemedicine. For example, the surgical staff faces more serious difficulties compared to non-surgical specialists during the COVID-19 pandemic. The primary concerns include the safest solutions for protecting healthcare staff and patients and the ability to provide adequate surgical care. Additionally, the adverse effects of any surgery delays and the financial consequences complicate the picture. Therefore, patients' admission during the COVID-19 pandemic should be taken into consideration, as well as preoperative measures. The COVID-19 situation brings particular risk to patients during surgery, where preoperative morbidity and mortality rise in either asymptomatic or symptomatic COVID-19 patients. This review discusses the recent factors associated with surgical complications, mortality rates, outcomes, and experience in COVID-19 surgical patients.
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Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection
(Wiley, 2021-02)
The WAPM (World Association of Perinatal Medicine) Working Group on COVID-19
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To evaluate the maternal and perinatal outcomes of pregnancies affected by SARS-CoV-2 infection.
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Effectiveness after immunization with BNT162b2 and Gam-COVID-Vac for SARS-CoV-2 and neutralizing antibody titers in health care workers
(Walter de Gruyter GmbH, 2024-05-24)
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Cibrev, Dragan
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Kerala, Coskun
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Ajeti, Valdrina
Objectives The aim of this study was to describe the effectiveness of the vaccines (Tozinameran and Sputnik V), administered on a convenience sample of healthcare workers, and also to describe the relationship between the levels of neutralizing antibodies (NAbs) and the type of vaccine used, as well as their association with incident cases during follow-up. Methods The study included 262 participants, who underwent vaccination during the period from September 2021 until August 2022. For determining the levels of NAbs we used the CLIA based method, and all the samples were processed with the SNIBE Maglumi 800 analyzer. The patients were observed for one year for occurrence of incident infection. Results The participants with prior SARS-CoV-2 positivity showed substantially higher titer of NAbs (8.86 vs. 0.94, p<0.001). The participants in the Gam-COVID-Vac group had median levels of NAbs of 1.57 (IQR 0.42–5.73), while they in the Tozinameran group showed substantially higher levels of 2.37 (IQR 0.9–6.27). The incident cases after immunization had substantially lower median values of NAbs when compared to the rest (0.48 vs. 3.97, p<0.001), and the interval between the second dose and the serological measurements were similar. Conclusions The current study showed that the tested vaccines demonstrated vaccine effectiveness of over 50 % during the first year after the vaccination in a sample of health care workers. Although health care workers remain separate population group, when compared to the rest, the results could be extrapolated to populations with similar age and immune experience.
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VACCINE BREAKTHROUGH INFECTIONS IN COVID-19 PATIENTS - SINGLE CENTER STUDY IN THE REPUBLIC OF NORTH MACEDONIA
(Македонско лекарско друштво = Macedonian medical association/De Gruyter, 2022)
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Matevska, Sofija
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Our study evaluates vaccine breakthrough infections in Coronavirus Disease 2019 (COVID-19) patients who presented for medical examination at a tertiary care hospital in Skopje, Republic of North Macedonia. We retrospectively evaluated medical files of 249 completely vaccinated patients who presented at the hospital since June 2021 till October 2021, with a clinical picture of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection. The average time from complete vaccination to symptom onset was 79.8±41.8 days. Out of 249 patients, 158(63.45%) were treated as outpatients, and 91(36.55%) were hospitalized. From the hospitalized patients, 61(67.03%) were discharged and 30(32.97) died. Breakthrough infections occurred in the Sinopharm vaccine group in 45.78%, Sinovac in 20.08%, Pfizer in 14.86%, AstraZeneca in 10.84% and Sputnik in 7.23%. The highest mortality was found in patients vaccinated with mRNA1273 vaccine, followed by inactivated virus containing vaccine and with non replicating viral vector vaccine, while the lowest mortality was found in those vaccinated with either BNT162b2 vaccine or human adenovirus vector-based COVID-19 vaccine. Male gender (p=0.006), age over 65 years (p=0.002) and presence of comorbidities (p=0.006) were major contributing factors for a poor outcome in vaccinated hospitalized patients with COVID-19. Due to the uneven distribution of the samples in our patient cohort it would be misleading to look at breakthrough cases, disease severity and outcome by vaccine brand due to different representation of vaccine brands. Breakthrough infection, hospitalization, and death from COVID -19 could differ across different vaccination profiles.

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