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1.
J Hosp Infect ; 2023 Jun 10.
Article in English | MEDLINE | ID: covidwho-20235425

ABSTRACT

BACKGROUND: Surgical site infection (SSI) is a health-threatening complication following Caesarean section (CS); however, to our knowledge, there is no worldwide estimate of the burden of post-CS SSIs. Therefore, this systematic review and meta-analysis aimed to estimate the global and regional incidence of post-CS SSI and its associated factors. METHODS: We systematically searched international scientific databases for observational studies published from January 2000 to March 2023, without language or geographical restrictions. The pooled global incidence rate was estimated using a random-effects meta-analysis (REM), and then stratified by World Health Organization (WHO)-defined regions as well as by socio-demographic and study characteristics. We also analysed causative pathogens and associated risk factors of SSIs using REM. We assessed heterogeneity with I2. RESULTS: We included 180 eligible studies (207 datasets) involving 2,188,242 participants from 58 countries. The pooled global incidence of post-CS SSI was 5.63% (95% CI, 5.18%-6.11%). The highest and lowest post-CS SSI incidences were estimated for African (11.91%, 9.67-14.34%), and North-America (3.87%, 3.02-4.83%) regions, respectively. The incidence was significantly higher in countries with lower levels of income and human development index. The pooled incidence estimates have steadily increased over time, with the highest incidence rate during the COVID-19 pandemic (2019-2023). Staphylococcus aureus and Escherichia coli were the most prevalent pathogens. Several risk factors were identified. CONCLUSION: We found an increasing and substantial burden from post-CS SSIs, especially in low-income countries. Further research, greater awareness, and the development of effective prevention and management strategies are warranted to reduce post-CS SSIs.

2.
Can J Infect Dis Med Microbiol ; 2023: 6957341, 2023.
Article in English | MEDLINE | ID: covidwho-20235154

ABSTRACT

Purpose: Maintaining the proper fluid balance is a fundamental step in the management of hospitalized patients. The current study evaluated the impact of negative fluid balance on outcomes of patients with confirmed COVID-19. Methods: We considered the negative fluid balance as a higher output fluid compared to the input fluid. The fluid balance was categorized into four groups (group 4: -850 to -500 ml/day; group 3: -499 to -200 ml/day, group 2: -199 to 0 ml/day, and group 1 : 1 to 1000 ml/day) and included ordinally in the model. The outcomes were all-cause mortality, length of hospitalization, and improvement in oxygen saturation. Results: The fluid balance differed significantly among nonsurvivors and survivors (MD: -317.93, 95% CI: -410.21, -225.69, and p < 0.001). After adjusting for potential confounders, there was a significantly lower frequency of mortality in patients with negative fluid balance compared to the controls (aRR: 0.69, 95% CI: 0.57, 0.84, and p < 0.001). Similarly, the length of hospitalization was significantly shorter in the negative fluid balance group in comparison to the control group (aMD: -1.01, 95% CI: -1.74, -0.28, and p=0.006). Conclusion: We determined that the negative fluid balance was associated with favorable outcomes in COVID-19 patients. The negative fluid balance was associated with the reduced mortality rate and length of hospitalization as well as improvement in oxygen saturation. Moreover, the NT-proBNP >781 pg/mL and fluid balance >-430 mL might be the predictors for positive fluid balance and mortality, respectively.

3.
EClinicalMedicine ; 56: 101786, 2023 Feb.
Article in English | MEDLINE | ID: covidwho-2165233

ABSTRACT

Background: The higher hospitalisation rates of those aged 0-19 years (referred to herein as 'children') observed since the emergence of the immune-evasive SARS-CoV-2 Omicron variant and subvariants, along with the persisting vaccination disparities highlighted a need for in-depth knowledge of SARS-CoV-2 sero-epidemiology in children. Here, we conducted this systematic review to assess SARS-CoV-2 seroprevalence and determinants in children worldwide. Methods: In this systematic review and meta-analysis study, we searched international and preprinted scientific databases from December 1, 2019 to July 10, 2022. Pooled seroprevalences were estimated according to World Health Organization (WHO) regions (at 95% confidence intervals, CIs) using random-effects meta-analyses. Associations with SARS-CoV-2 seroprevalence and sources of heterogeneity were investigated using sub-group and meta-regression analyses. The protocol used in this study has been registered in PROSPERO (CRD42022350833). Findings: We included 247 studies involving 757,075 children from 70 countries. Seroprevalence estimates varied from 7.3% (5.8-9.1%) in the first wave of the COVID-19 pandemic to 37.6% (18.1-59.4%) in the fifth wave and 56.6% (52.8-60.5%) in the sixth wave. The highest seroprevalences in different pandemic waves were estimated for South-East Asia (17.9-81.8%) and African (17.2-66.1%) regions; while the lowest seroprevalence was estimated for the Western Pacific region (0.01-1.01%). Seroprevalence estimates were higher in children at older ages, in those living in underprivileged countries or regions, and in those of minority ethnic backgrounds. Interpretation: Our findings indicate that, by the end of 2021 and before the Omicron wave, around 50-70% of children globally were still susceptible to SARS-CoV-2 infection, clearly emphasising the need for more effective vaccines and better vaccination coverage among children and adolescents, particularly in developing countries and minority ethnic groups. Funding: None.

4.
Expert Rev Vaccines ; 21(6): 843-851, 2022 06.
Article in English | MEDLINE | ID: covidwho-1740642

ABSTRACT

INTRODUCTION: We performed a systematic review and meta-analysis to evaluate the acceptance of a COVID-19 vaccine among pregnant women and its determinants. METHOD: We searched the bibliographic databases (Scopus, Medline, and Web of Science) for the relevant studies from 1 January 2020 to 11 July 2021. We pooled the prevalence of vaccine acceptance among pregnant women using a random-effects model and conducted subgroup analyses to explore its determinants. The result was expressed as a pooled prevalence percentage and adjusted odds ratio (aOR) with 95% CIs. RESULTS: We found ten studies that were suitable, with 16, 696 participants from 32 countries. COVID-19 vaccination acceptability in pregnant women was 54 percent globally (95% CI: 45, 62; I2= 99.05). There was no association between sociodemographic factors including age >35 years (aOR: 1.17, 95%CI: 0.95, 1.43), high education (aOR: 1.03, 95%CI: 0.79, 1.35), income levels (aOR: 1.18, 95%CI: 0.80, 1.75), knowledge scores (aOR: 2.55, 95% CI: 0.78, 8.34) and COVID-19 vaccine acceptance. CONCLUSION: About half of pregnant women accepted the COVID-19 vaccine. We did not find any association between sociodemographic factors and COVID-19 vaccine acceptance. However, these findings should be considered with caution due to small number of studies and the substantial heterogeneity between them.


Subject(s)
COVID-19 , Pregnant Women , Adult , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Female , Humans , Pregnancy , Prevalence , Vaccination
5.
Clin Microbiol Infect ; 27(12): 1762-1771, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1433091

ABSTRACT

BACKGROUND: With limited vaccine supplies, an informed position on the status of SARS-CoV-2 infection in people can assist the prioritization of vaccine deployment. OBJECTIVES: We performed a systematic review and meta-analysis to estimate the global and regional SARS-CoV-2 seroprevalences around the world. DATA SOURCES: We systematically searched peer-reviewed databases (PubMed, Embase and Scopus), and preprint servers (medRxiv, bioRxiv and SSRN) for articles published between 1 January 2020 and 30 March 2021. STUDY ELIGIBILITY CRITERIA: Population-based studies reporting the SARS-CoV-2 seroprevalence in the general population were included. PARTICIPANTS: People of different age groups, occupations, educational levels, ethnic backgrounds and socio-economic status from the general population. INTERVENTIONS: There were no interventions. METHODS: We used the random-effects meta-analyses and empirical Bayesian method to estimate the pooled seroprevalence and conducted subgroup and meta-regression analyses to explore potential sources of heterogeneity as well as the relationship between seroprevalence and socio-demographics. RESULTS: We identified 241 eligible studies involving 6.3 million individuals from 60 countries. The global pooled seroprevalence was 9.47% (95% CI 8.99-9.95%), although the heterogeneity among studies was significant (I2 = 99.9%). We estimated that ∼738 million people had been infected with SARS-CoV-2 (as of December 2020). Highest and lowest seroprevalences were recorded in Central and Southern Asia (22.91%, 19.11-26.72%) and Eastern and South-eastern Asia (1.62%, 1.31-1.95%), respectively. Seroprevalence estimates were higher in males, persons aged 20-50 years, in minority ethnic groups living in countries or regions with low income and human development indices. CONCLUSIONS: The present study indicates that the majority of the world's human population was still highly susceptible to SARS-CoV-2 infection in mid-2021, emphasizing the need for vaccine deployment to vulnerable groups of people, particularly in developing countries, and for the implementation of enhanced preventive measures until 'herd immunity' to SARS-CoV-2 has developed.


Subject(s)
COVID-19 , SARS-CoV-2 , Seroepidemiologic Studies , Bayes Theorem , COVID-19/epidemiology , Global Health , Humans
6.
Infect Dis Obstet Gynecol ; 2021: 9952701, 2021.
Article in English | MEDLINE | ID: covidwho-1277021

ABSTRACT

During the coronavirus disease 2019 (COVID-19) pandemic, the number of pregnant women and neonates suffering from COVID-19 increased. However, there is a lack of evidence on clinical characteristics and neonatal outcomes in pregnant women with COVID-19. We evaluated short-term outcomes (4 weeks postdischarge) and symptoms in neonates born to mothers infected with COVID-19. In this retrospective cohort study, we included all neonates born to pregnant women with COVID-19 admitted to Ayatollah Rohani Hospital, Babol, Iran, from February 10 to May 20, 2020. Clinical features, treatments, and neonatal outcomes were measured. Eight neonates were included in the current study. The mean gestational age and birth weight of newborns were 37 ± 3.19 weeks (30₊6-40) and 3077.50 ± 697.64 gr (1720-3900), respectively. Apgar score of the first and fifth minutes in all neonates was ≥8 and ≥9 out of 10, respectively. The most clinical presentations in symptomatic neonates were respiratory distress, tachypnea, vomiting, and feeding intolerance. This manifestation and high levels of serum C-reactive protein (CRP) in three infants are common in neonatal sepsis. The blood culture in all of them was negative. They have been successfully treated with our standard treatment. Our pregnant women showed a pattern of clinical characteristics and laboratory results similar to those described for nonpregnant COVID-19 infection. This study found no evidence of intrauterine or peripartum transmission of COVID-19 from mother to her child. Furthermore, the long-term outcomes of neonates need more study.


Subject(s)
COVID-19/epidemiology , Infectious Disease Transmission, Vertical , Pregnancy Complications, Infectious/epidemiology , Respiratory Distress Syndrome, Newborn/epidemiology , SARS-CoV-2/isolation & purification , Apgar Score , Birth Weight , COVID-19/complications , COVID-19/diagnosis , COVID-19/transmission , COVID-19 Nucleic Acid Testing/statistics & numerical data , Female , Follow-Up Studies , Gestational Age , Humans , Infant, Low Birth Weight , Infant, Newborn , Infant, Premature , Iran/epidemiology , Lung/diagnostic imaging , Pregnancy , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/virology , RNA, Viral/isolation & purification , Respiratory Distress Syndrome, Newborn/diagnosis , Respiratory Distress Syndrome, Newborn/virology , Retrospective Studies , SARS-CoV-2/genetics
7.
J Interferon Cytokine Res ; 41(4): 149-152, 2021 04.
Article in English | MEDLINE | ID: covidwho-1196961

ABSTRACT

The most recently discovered interferon (IFN) family, type III IFNs or lambda IFNs (IFN-λs) are caused by viral infection and act in mucosal barriers, such as the respiratory tract. In this study, we assessed the serum levels of IFN-λs in new coronavirus disease-2019 (COVID-19) patients. Sixty-four COVID-19 patients were enrolled in this study. All cases were divided into the intensive care unit (ICU) and non-ICU groups according to their symptoms. Fourteen samples of healthy controls were also included. The serum levels of IFN-λ1 and IFN-λ2 were analyzed by specific enzyme-linked immunosorbent assay (ELISA) kits. The concentrations of IFN-λ1 and IFN-λ2 induced in the serum of non-ICU patients (836.7 ± 284.6 and 798.8 ± 301.5 pg/mL, respectively) were higher than found in ICU patients (81.57 ± 34.25 and 48.32 ± 28.13 pg/mL, respectively) (P = 0.004 and P = 0.006, respectively) and healthy controls (85.57 ± 33.63 and 65.82 ± 21.26 pg/mL, respectively) (P = 0.03 and P = 0.04, respectively). Meanwhile, no significant differences were found in the concentration of both cytokines between the ICU patients and healthy controls. We conclude that higher levels of IFN-λs are associated with decreased clinical manifestations in COVID-19 patients. These cytokines could be a promising therapeutic agent to avoid the overwhelming consequences of COVID-19.


Subject(s)
COVID-19 , Interferons/blood , Interleukins/blood , SARS-CoV-2/metabolism , Adult , Aged , COVID-19/blood , COVID-19/prevention & control , Enzyme-Linked Immunosorbent Assay , Female , Humans , Male , Middle Aged
8.
APMIS ; 129(5): 271-279, 2021 May.
Article in English | MEDLINE | ID: covidwho-1165803

ABSTRACT

There is very little knowledge about the immune responses, particularly cellular immunity to coronavirus disease 2019 (COVID-19). The main objective of this study was to evaluate the frequency of T helper (Th) cell subtypes, including Th1, Th17, and Treg cells, in moderate-to-severe and critical COVID-19 patients compared to healthy controls. Twenty-nine moderate-to-severe and 13 critical patients confirmed for COVID-19, and 15 healthy subjects were included in this study. Interferon-γ (IFN-γ)-producing Th1 and interleukin-17A-producing Th17 and Treg cells in peripheral blood were measured with flow cytometry. The frequency of Th1 and Th17 was significantly decreased in critical patients compared to healthy subjects (aMD: -2.76 and - 2.34) and moderate-to-severe patients (aMD: -1.89 and - 1.89), respectively (p < 0.05). Differences were not significant between moderate-to-severe patients and healthy subjects for both Th1 (p = 0.358) and Th17 (p = 0.535), respectively. In contrast, significant difference was not observed between study subjects regarding the frequency of Treg cells. Patients with critical COVID-19 had a markedly lower Th1/Treg and Th17/Treg ratios compared with the controls and moderate-to-severe cases. Our study showed a dysregulated balance of Th1 and Th17 cells and its relation to the severity of COVID-19.


Subject(s)
COVID-19/immunology , SARS-CoV-2/immunology , T-Lymphocytes, Regulatory/immunology , Th1 Cells/immunology , Th17 Cells/immunology , Adolescent , Adult , Aged , Aged, 80 and over , CD4 Lymphocyte Count , COVID-19/pathology , Critical Illness , Female , Flow Cytometry , Humans , Interferon-gamma/biosynthesis , Interleukin-17/biosynthesis , Male , Middle Aged , Severity of Illness Index , Young Adult
9.
Microb Pathog ; 153: 104779, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1062521

ABSTRACT

BACKGROUND: During viral infection, inhibitory receptors play a key role in regulating CD8 T-cell activity. The objective of this research was to investigate programmed cell death protein 1 (PD-1), T-cell immunoglobulin and mucin domain-containing protein-3 (TIM-3), and CD39 exhaustion markers in CD8 T cells of new coronavirus disease-2019 (COVID-19) patients. METHODS: A total of 44 patients with COVID-19 (17 subjects in a critical group and 27 patients in a non-critical group) and 14 healthy controls, who were admitted to Hospitals in Babol, were recruited to the study. In subjects' peripheral blood mononuclear cells (PBMCs), we compared the phenotype of CD8 T lymphocytes, expressing PD-1, TIM-3, or CD39, both alone and in various combinations. RESULTS: The findings showed that the percentage of CD8+ cells was significantly lower in patients. Critical and non-critical patients were more likely than healthy controls to have an escalated frequency of CD8+ TIM-3+, CD8+ CD39+, and CD8+ TIM-3+ CD39+ cells. No significant differences were observed between all groups in the CD8+ PD-1+ cell counts. There was also no difference between three groups regarding the counts of CD8+ TIM-3+ PD-1+, CD8+ PD-1+ CD39+, and CD8+ TIM-3+ PD-1+ CD39+ cells. The counts of non-exhausted cells were significantly lower in critical and non-critical individuals compared to the healthy individuals' value. CONCLUSION: Patients, infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), altered exhausted CD8 T lymphocytes with CD39 and TIM-3 exhaustion markers, which may account the dysregulated immune response found in COVID-19.


Subject(s)
Apyrase/biosynthesis , CD8-Positive T-Lymphocytes/immunology , COVID-19/pathology , Hepatitis A Virus Cellular Receptor 2/biosynthesis , Programmed Cell Death 1 Receptor/biosynthesis , Adolescent , Adult , Aged , Aged, 80 and over , Biomarkers/analysis , Female , Humans , Iran , Lymphocyte Count , Male , Middle Aged , SARS-CoV-2/immunology , Young Adult
10.
Clin Microbiol Infect ; 27(3): 331-340, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-928900

ABSTRACT

OBJECTIVES: COVID-19 has been arguably the most important public health concern worldwide in 2020, and efforts are now escalating to suppress or eliminate its spread. In this study we undertook a meta-analysis to estimate the global and regional seroprevalence rates in humans of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and to assess whether seroprevalence is associated with geographical, climatic and/or sociodemographic factors. METHODS: We systematically reviewed PubMed, Scopus, Embase, medRxiv and bioRxiv databases for preprints or peer-reviewed articles (up to 14 August 2020). Study eligibility criteria were population-based studies describing the prevalence of anti-SARS-CoV-2 (IgG and/or IgM) serum antibodies. Participants were people from different socioeconomic and ethnic backgrounds (from the general population), whose prior COVID-19 status was unknown and who were tested for the presence of anti-SARS-CoV-2 serum antibodies. We used a random-effects model to estimate pooled seroprevalence, and then extrapolated the findings to the global population (for 2020). Subgroup and meta-regression analyses explored potential sources of heterogeneity in the data, and relationships between seroprevalence and sociodemographic, geographical and/or climatic factors. RESULTS: In total, 47 studies involving 399 265 people from 23 countries met the inclusion criteria. Heterogeneity (I2 = 99.4%, p < 0.001) was seen among studies; SARS-CoV-2 seroprevalence in the general population varied from 0.37% to 22.1%, with a pooled estimate of 3.38% (95%CI 3.05-3.72%; 15 879/399 265). On a regional level, seroprevalence varied from 1.45% (0.95-1.94%, South America) to 5.27% (3.97-6.57%, Northern Europe), although some variation appeared to relate to the serological assay used. The findings suggested an association of seroprevalence with income levels, human development indices, geographic latitudes and/or climate. Extrapolating to the 2020 world population, we estimated that 263.5 million individuals had been exposed or infected at the time of this study. CONCLUSIONS: This study showed that SARS-CoV-2 seroprevalence varied markedly among geographic regions, as might be expected early in a pandemic. Longitudinal surveys to continually monitor seroprevalence around the globe will be critical to support prevention and control efforts, and might indicate levels of endemic stability or instability in particular countries and regions.


Subject(s)
COVID-19/epidemiology , Global Health , SARS-CoV-2/immunology , Adult , Antibodies, Viral/blood , COVID-19/diagnosis , COVID-19/ethnology , COVID-19/mortality , COVID-19 Serological Testing , Child , Climate , Female , Geography , Humans , Male , SARS-CoV-2/isolation & purification , Seroepidemiologic Studies , Socioeconomic Factors , Time Factors
11.
J Travel Med ; 27(7)2020 Nov 09.
Article in English | MEDLINE | ID: covidwho-744565

ABSTRACT

BACKGROUND: Despite the large number of pregnant women with the coronavirus disease 2019 (COVID-19), there is not enough analytical study to compare maternal and fetal consequences of COVID-19 infected with non-infected pregnancies. This cohort study aimed to compare maternal and fetal consequences of COVID-19 infected with non-infected pregnancies. METHODS: We included pregnant women with and without COVID-19 who were admitted to Arash Hospital in Tehran, Iran, from 1 March to 1 September 2020. Clinical features, treatments, and maternal and fetal outcomes were assessed. RESULTS: A total of 199 women enrolled, including 66 COVID-19 infected and 133 non-infected pregnant women prospectively. Caesarean section was carried out in total 105 women (52.76%). A significant difference was found in term of delivery type between COVID-19 infected and non-infected pregnant women [adjusted risk ratio (aRR): 1.31, 95% confidence interval (CI): 1.04, 1.65, P = 0.024]. No significant association was found between COVID-19 infection and preterm birth (aRR: 1.16, 95% CI: 0.54, 2.48, P = 0.689), low birth weight (aRR: 1.13, 95% CI: 0.55, 2.31, P = 0.723), gestational diabetes (aRR: 1.67, 95% CI: 0.81, 3.42, P = 0.160), pre-eclampsia (aRR: 2.02, 95% CI: 0.42, 6.78, P = 0.315), intrauterine growth restriction (aRR: 0.16, 95% CI: 0.02, 1.86, P = 0.145), preterm rupture of membrane (aRR: 0.19, 95% CI: 0.02, 2.20, P = 0.186), stillbirth (aRR: 1.41, 95% CI: 0.08, 18.37, P = 0.614), postpartum haemorrhage (aRR: 1.84, 95% CI: 0.39, 8.63, P = 0.185), neonatal intensive care unit (ICU) admission (aRR: 1.84, 95% CI: 0.77, 4.39, P = 0.168) and neonatal sepsis (aRR: 0.84, 95% CI: 0.48, 1.48, P = 0.568). The percentage of patients (4/66, 6.06%) being admitted to the ICU was significantly higher than the control group (0%) (P < 0.001). CONCLUSION: Basically, although pregnancy and neonatal outcomes were not significantly different, the need for ICU care for pregnant women with COVID-19 was significantly higher compared with those without COVID-19.


Subject(s)
Coronavirus Infections/epidemiology , Pneumonia, Viral/epidemiology , Pregnancy Complications, Infectious/diagnosis , Pregnancy Complications, Infectious/epidemiology , Pregnancy Outcome , Premature Birth/epidemiology , COVID-19 , Cesarean Section/statistics & numerical data , Cohort Studies , Coronavirus Infections/prevention & control , Female , Humans , Infant Health , Infant, Newborn , Intensive Care Units, Neonatal/statistics & numerical data , Iran , Maternal Health , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Pregnancy , Prospective Studies , Reference Values
12.
Trials ; 21(1): 467, 2020 Jun 03.
Article in English | MEDLINE | ID: covidwho-505944

ABSTRACT

OBJECTIVES: Comparison of the effect of hydroxychloroquine with placebo to prevent infection from the COVID -19 virus among healthcare professionals TRIAL DESIGN: Single centre, 2-arm, double-blind randomised (ratio 1:1) placebo-controlled trial PARTICIPANTS: Treatment staff who are in contact with patients and have at least 3 shifts a week in Arash hospital affiliated with Tehran University of Medical Sciences, in Iran and who consent to participate in the study. Exclusion criteria include: History of COVID -19 virus infection, clinical symptoms such as fever, nausea, dyspnea and myalgia in the past two months, history of underlying diseases hypersensitivity to hydroxychloroquine and G6PD enzyme deficiency. INTERVENTION AND COMPARATOR: Intervention group: Hydroxychloroquine 200 mg tablet of Amin Pharmaceutical. CONTROL GROUP: placebo which is completely similar in form and taste to 200 mg hydroxychloroquine tablet and is manufactured by the same factory (Amin Pharmacy). The dosage is two tablets daily, once a week for one to three months (based on the duration of the Coronavirus epidemic in Tehran). MAIN OUTCOMES: Confirmed COVID-19 virus infection using Polymerase chain reaction (PCR) test is the primary outcome. The time period for measuring the primary outcome is any infection within the trial period up to one month after taking the last dose. RANDOMISATION: The randomized block allocation method was developed using Stata version 15 software by an independent researcher, using a block size of six. Allocation to the two treatment groups will be conducted by this researcher using paper labels (random 10-digit codes) in a 1:1 ratio t The labels will be attached to the drug packages in order of randomization. Drug packages will be arranged in a box according to the randomization list. BLINDING (MASKING): Participants and caregivers are blinded to group assignment and the data will be analyzed by an independent statistical expert who is unaware of the treatment allocation. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): A total of 282 participants will be randomised with 141 participants the Hydroxychloroquineeach intervention group and 141 participants to the placebo control group TRIAL STATUS: The protocol version number is 99-1-101-47091 and the approval ID is IR.TUMS.VCR.REC.1399.001 and recruitment began April 7, 2020, and is anticipated to be complete by August 7, 2020. TRIAL REGISTRATION: The name of the trial register is Iranian registry of clinical trial (IRCT), registration number is IRCT20120826010664N6, date of trial registration is April 7, 2020, FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
Antiviral Agents/administration & dosage , Betacoronavirus/drug effects , Coronavirus Infections/prevention & control , Hydroxychloroquine/administration & dosage , Infectious Disease Transmission, Patient-to-Professional/prevention & control , Occupational Exposure/adverse effects , Occupational Health , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Antiviral Agents/adverse effects , Betacoronavirus/pathogenicity , COVID-19 , Chemoprevention , Coronavirus Infections/diagnosis , Coronavirus Infections/virology , Double-Blind Method , Humans , Hydroxychloroquine/adverse effects , Iran , Pneumonia, Viral/diagnosis , Pneumonia, Viral/virology , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , SARS-CoV-2 , Time Factors , Treatment Outcome
13.
Rom J Intern Med ; 58(3): 161-167, 2020 Sep 01.
Article in English | MEDLINE | ID: covidwho-246756

ABSTRACT

BACKGROUND: In December 2019, China has experienced an outbreak of novel coronavirus disease 2019 (COVID-19). Coronavirus has now spread to all of the continents. We aimed to consider clinical characteristics, laboratory data of COVID-19 that provided more information for the research of this novel virus. METHODS: We performed a retrospective cohort study on the clinical symptoms and laboratory findings of a series of the 100 confirmed patients with COVID-19. These patients were admitted to the hospitals affiliated to Babol University of Medical Sciences (Ayatollah Rohani, Shahid Beheshti and Yahyanejad hospitals) form 25 February 2020 to 12 March 2020. RESULTS: Nineteen patients died during hospitalization and 81 were discharged. Non-survivor patients had a significantly higher C-reactive protein (CRP) (MD: 46.37, 95% CI: 20.84, 71.90; P = 0.001), white blood cells (WBCs) (MD: 3.10, 95% CI: 1.53, 4.67; P < 0.001) and lower lymphocyte (MD: -8.75, 95% CI: -12.62, -4.87; P < 0.001) compared to survivor patients Data analysis showed that comorbid conditions (aRR: 2.99, 95% CI: 1.09, 8.21, P = 0.034), higher CRP levels (aRR: 1.02, 95% CI: 1.01, 1.03, P = 0.044), and lower lymphocyte (aRR: 0.82, 95% CI: 0.73, 0.93, P = 0.003) were associated with increased risk of death. CONCLUSIONS: Based on our findings, most non-survivors are elderly with comorbidities. Lymphopenia and increased levels of WBCs along with elevated CRP were associated with increased risk of death. Therefore, it is best to be regularly assessed these markers during treatment of COVID-19 patients.


Subject(s)
Coronavirus Infections , Pandemics , Pneumonia, Viral , Age Factors , Betacoronavirus , Biomarkers/blood , C-Reactive Protein/analysis , COVID-19 , Coronavirus Infections/blood , Coronavirus Infections/physiopathology , Female , Humans , Iran/epidemiology , Leukocyte Count/statistics & numerical data , Male , Middle Aged , Mortality , Pneumonia, Viral/blood , Pneumonia, Viral/diagnosis , Pneumonia, Viral/etiology , Pneumonia, Viral/mortality , Pneumonia, Viral/physiopathology , Retrospective Studies , Risk Factors , SARS-CoV-2 , Survival Analysis
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