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1.
AACE Clin Case Rep ; 8(3): 116-118, 2022.
Article in English | MEDLINE | ID: covidwho-1943908

ABSTRACT

Background: Although SARS-CoV-2 virus infection has been reported to cause subacute thyroiditis, the mRNA vaccine for SARS-CoV-2 is suspected to induce thyroiditis with thyrotoxicosis. Case Report: : We describe 3 patients with no history of thyroid disease who presented with symptomatic, biochemical, and radiological evidence of thyroiditis with thyrotoxicosis, 10 to 20 days after receiving either Pfizer Bio-NTech or Moderna COVID-19 mRNA vaccines. All patients presented with thyrotoxicosis but with negative thyroid-stimulating immunoglobulins for Graves disease and no autonomous nodules. Two patients underwent thyroid uptake scans that confirmed thyroiditis. One patient had significantly increased erythrocyte sedimentation rate and interleukin-6. All patients showed improvement in symptoms with nonsteroidal anti-inflammatory drugs, and 1 patient eventually required steroids for symptom control. Discussion: The mRNA vaccine for SARS-CoV-2 was associated with thyroiditis and led to thyrotoxicosis. Elevated proinflammatory markers and cytokines after vaccines may play a major role. Conclusion: Our case series report highlights a possible relationship between the COVID-19 mRNA vaccine and thyroiditis with thyrotoxicosis, which has not been recognized by health providers.

2.
Cureus ; 14(5): e25388, 2022 May.
Article in English | MEDLINE | ID: covidwho-1912118

ABSTRACT

Giant cell arteritis (GCA) has been reported post the coronavirus disease 2019 (COVID-19) vaccination, especially with the mRNA vaccine. A normal erythrocyte sedimentation rate (ESR) is seen in some GCA patients. This report describes a 68-year-old gentleman who presented with a right-sided temporal headache for three weeks, starting three to five days after his second dose of the ChAdOx1 nCoV-19 vaccine, a viral vector vaccine, which was given seven weeks post the first dose. On presentation, he developed blurred vision in the left eye, and it progressed to complete vision loss four days later. He also had episodes of blurred vision in the right eye. The blood test showed a mildly elevated C-reactive protein of 29 mg/L and a normal erythrocyte sedimentation rate (ESR) of 4 mm/hr. Optical coherence tomography showed anterior ischaemic optic neuropathy in the left eye and retinal ischemia in the right eye. Bilateral giant cell arteritis (GCA) was confirmed on temporal artery biopsy. He was treated with methylprednisolone pulse therapy followed by prednisolone. He re-presented with intermittent blurry vision in the right eye three months later. He was treated with methylprednisolone pulse therapy again, followed by prednisolone, aspirin, and tocilizumab. This case describes a patient who developed GCA post ChAdOx1 nCoV-19 vaccination with a normal ESR. Further studies are needed to investigate this relationship as causal or incidental and the likelihood of low-level inflammatory makers in such a situation.

3.
Ann Med Surg (Lond) ; 79: 104039, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1894773
4.
International Journal of Life Science and Pharma Research ; 12(3):L109-L114, 2022.
Article in English | English Web of Science | ID: covidwho-1884892

ABSTRACT

India is under the second wave of the coronavirus disease (COVID-19). It seems that the second wave has created more impact than the first wave with an increased mortality rate. The mortality rate among young age group below 17 years is 0.05% with an increase of 16.6% above 17 years. Various studies have revealed that COVID-19 positive individuals show altered levels of both biochemical and hematological parameters with increased severity. To the best of our knowledge, no studies have investigated the altered levels with different age group. Hence, the study's primary goal is to assess biochemical and haematological parameters in COVID-19 positive individuals and compare the levels in different age groups of the South Indian population in the second wave of COVID-19. The subjects were divided into 3 groups based on their age as between 19-40 years, 41-60 years, and 61-80 years. The biochemical parameters measured included liver and renal function tests, electrolytes, inflammatory markers, and blood glucose. ESR and haematological parameters were measured. Under biochemical parameters, serum urea, uric acid, and creatinine increased significantly with increasing age group, whereas serum albumin decreased significantly with increasing age group. With ferritin and CRP, there was statistical significance among different age groups. It was found that diabetic patients with high HbA1C levels with increase age are more prone to COVID-19 infection. On hematological investigation significant decrease in the eosinophil count and increased basophil count were observed among different age group. The study concludes that compared to younger age groups, older ones with COVID-19 showed increase in immune and inflammatory markers, Markers of the adaptive immune response also increased with age. Hence, continuous monitoring and additional care must be given the older ones to reduce the effects of severity of COVID-19 among south Indian population.

5.
Int J Pediatr Adolesc Med ; 2022 May 30.
Article in English | MEDLINE | ID: covidwho-1867255

ABSTRACT

Background: Since the initial emergence of the novel SARS-CoV-2 coronavirus responsible for the 2019 coronavirus disease (COVID-19) pandemic, many studies have been exploring the nature and characteristics of this virus and its associated clinical manifestations. The present study aimed to describe the clinical presentation and outcomes of COVID-19 infections in pediatric patients. Methods: A retrospective review of findings associated with 143 pediatric patients (age <14 years) with a confirmed COVID-19 diagnosis who had undergone inpatient or outpatient treatment at King Faisal Specialist Hospital and Research Center in Riyadh, Saudi Arabia, between March 2020 and October 2020, was conducted. The analyzed data included patient demographic information, pre-existing medical conditions, symptoms, interventions, and outcomes. Results: The median age of this patient population was 7 years. Of these 143 patients, 67 (46.8%) had known pre-existing medical conditions including bronchial asthma (12.8%), chronic lung disease (CLD) (3%), congenital heart disease (CHD) (17%), primary immunodeficiencies (1.5%), malignancies (9.8%), and 7.5% were post-transplant patients. Thirty-seven patients (26%) were overweight or obese. Sixty-three of these patients (51%) were symptomatic, with the most common symptom being fever (55%). Ultimately, 45 patients (31%) required admission to the hospital, with a median duration of hospitalization of 9.6 days for admitted patients. There were no documented cases of infection-related mortality among this pediatric cohort, although 11 patients experienced post-infectious complications that primarily manifested as a loss of taste and smell. Conclusion: These findings suggest that pediatric COVID-19 patients tend to experience mild forms of disease, without any significant differences in disease severity as a function of patient gender or immune status.

6.
J Ayurveda Integr Med ; 13(1): 100420, 2022.
Article in English | MEDLINE | ID: covidwho-1838954

ABSTRACT

In ongoing viral pandemic named as COVID-19 also Severe Acute Respiratory illness (SARI) or Flue Like illness (FLI) reported surging in many cities of India and many of the patients opted for traditional medicine, in spite of they have been given a option of contemporary line of treatment instructed by health authorities, they opted to take traditional indian medicine that is Ayurvedic medicine. Present case series is a same novel experience of early diagnosing and treating mid aged, morbid individuals who took only Ayurvedic treatment and could get out of the disease without any complications. This case series had 10 mid aged, morbid patients with maximum symptoms of COVID-19 disease and their hemogram and CRP was suggestive of moderate to severe type COVID-19/FLI/SARI. They were diagnosed by contemporary methods of pathology and treated with Ayurvedic classical medicines Tamra Sinduradi Yoga and Bhunimbadi Kwath for 20 days along with continuing the medicines for their ongoing morbidities. All 10 patients showed recoveries without any complications, they reduced their all symptoms, drastic reduction in their CRP and corrections in their hemograms were observed and also they showed any complications neither physically nor in their pathological tests. Hence it can be concluded that early diagnosis and treating it with Ayurvedic medicine can manage viral pandemic issue in a very successful way.

7.
Clin Epidemiol Glob Health ; 14: 100966, 2022.
Article in English | MEDLINE | ID: covidwho-1797102

ABSTRACT

The COVID-19 outbreak sparked by SARS-CoV-2, begat significant rates of malady worldwide, where children with an abnormal post-COVID ailment called the Multisystem Inflammatory Syndrome (MIS-C), were reported by April 2020. Here we have reviewed the clinical characteristics of the pediatric patients and the prognosis currently being utilized. A vivid comparison of MIS-C with other clinical conditions has been done. We have addressed the probable etiology and fundamental machinery of the inflammatory reactions, which drive organ failure. The involvement of androgen receptors portrays the likelihood of asymptomatic illness in children below adolescence, contributing to the concept of antibody-dependent enhancement.

8.
Lancet Reg Health Am ; 11: 100244, 2022 Jul.
Article in English | MEDLINE | ID: covidwho-1783617

ABSTRACT

Background: We evaluated in-hospital mortality and outcomes incidence after hospital discharge due to COVID-19 in a Brazilian multicenter cohort. Methods: This prospective multicenter study (RECOVER-SUS, NCT04807699) included COVID-19 patients hospitalized in public tertiary hospitals in Brazil from June 2020 to March 2021. Clinical assessment and blood samples were performed at hospital admission, with post-hospital discharge remote visits. Hospitalized participants were followed-up until March 31, 2021. The outcomes were in-hospital mortality and incidence of rehospitalization or death after hospital discharge. Kaplan-Meier curves and Cox proportional-hazard models were performed. Findings: 1589 participants [54.5% male, age=62 (IQR 50-70) years; BMI=28.4 (IQR,24.9-32.9) Kg/m² and 51.9% with diabetes] were included. A total of 429 individuals [27.0% (95%CI,24.8-29.2)] died during hospitalization (median time 14 (IQR,9-24) days). Older age [vs<40 years; age=60-69 years-aHR=1.89 (95%CI,1.08-3.32); age=70-79 years-aHR=2.52 (95%CI,1.42-4.45); age≥80-aHR=2.90 (95%CI 1.54-5.47)]; noninvasive or mechanical ventilation at admission [vs facial-mask or none; aHR=1.69 (95%CI 1.30-2.19)]; SAPS-III score≥57 [vs<57; aHR=1.47 (95%CI 1.13-1.92)] and SOFA score≥10 [vs <10; aHR=1.51 (95%CI 1.08-2.10)] were independently associated with in-hospital mortality. A total of 65 individuals [6.7% (95%CI 5.3-8.4)] had a rehospitalization or death [rate=323 (95%CI 250-417) per 1000 person-years] in a median time of 52 (range 1-280) days post-hospital discharge. Age ≥ 60 years [vs <60, aHR=2.13 (95%CI 1.15-3.94)] and SAPS-III ≥57 at admission [vs <57, aHR=2.37 (95%CI 1.22-4.59)] were independently associated with rehospitalization or death after hospital discharge. Interpretation: High in-hospital mortality rates due to COVID-19 were observed and elderly people remained at high risk of rehospitalization and death after hospital discharge. Funding: Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro (FAPERJ), Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq) and Programa INOVA-FIOCRUZ.

9.
New Microbes New Infect ; 45: 100963, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1730012
10.
Sens Int ; 3: 100148, 2022.
Article in English | MEDLINE | ID: covidwho-1595847

ABSTRACT

BACKGROUND: The corona name derived from their crown like spike proteins attach with cell receptors. It belongs to coronaviradae family and nideovirales order, envelop virus, size range 65-125 â€‹nm and positive single standard RNA between 26.4 and 31.7 â€‹kb and contain 7096 amino acid. There are four subtypes that have been detected these are alpha, beta, gamma and delta. METHODOLOGY: The 267 covid-19 blood and nasopharyngeal samples were collected from Multan region. RNA extraction from nasopharyngeal samples and run the PCR. The blood samples use for clinical tests, Lactate dehydrogenase, serum ferritin level, D-Dimer, TG, cholesterol, thyphoidot, HDL, lymphocyte count and CRP. RESULTS: 127 (47.21%) out of 267 patients were covid-19 PCR positive and showed the amplification of ORF1ab, E, and N gene, while 140 individuals were covid-19 PCR negative and not showed the amplification of ORF1ab, E and N gene. The patients with negative Covid-19 PCR, the other analysis tests such as lactate dehydrogenase, HDL, ferritin, ESR, CBP, D-Dimer, Tg, cholesterol, CRP and CT scan. The patients effected covid-19 have higher values of D-Dimer, ESR, Neutrophils, LDH, CRP and ferritin level than normal ranges. However, the values of HDL, cholesterol and lymphocytes were decreased from the normal range.

11.
Pathogens ; 10(11)2021 Oct 26.
Article in English | MEDLINE | ID: covidwho-1488691

ABSTRACT

The COVID-19 pandemic continues around the world, where the United States is among the worst in terms of both morbidity and fatality of the viral infection. We aim to investigate the plausible link of tissue SARS-CoV-2 viral entry gene expression, such as TMPRSS2 and ACE2, with infection and death by gender during the COVID-19 pandemic in the United States. We find a significantly higher incidence of COVID-19 death in men than in women, even though SARS-CoV-2 infection in women is higher than in men. We discover that the expression of TMPRSS2 and ACE2 in intestine, but not in lung, tends to be positively associated with the incidence of SARS-CoV-2 infection in men. In contrast, the high incidence of death in men is negatively correlated with TMPRSS2/ACE2 expression in intestine. Strikingly, the correlation of TMPRSS2/ACE2 expression with SARS-CoV-2 infection and death is the opposite in females, compared with that in males. Interestingly, male hormone signaling seems to be involved in mortality, as the low expression of testosterone receptor AR in the prostate contributes to death in men according to age. These observations point to a plausible contribution of male hormone metabolism in the regulation of TMPRSS2/ACE2 signaling to fatality by SARS-CoV-2 infection in men.

12.
Meta Gene ; 31: 100990, 2022 Feb.
Article in English | MEDLINE | ID: covidwho-1482826

ABSTRACT

BACKGROUND: Coronavirus disease 2019 is characterized by the elevation of a broad spectrum of inflammatory mediators associated with poor disease outcomes. We aimed at an in-silico analysis of regulatory microRNA and their transcription factors (TF) for these inflammatory genes that may help to devise potential therapeutic strategies in the future. METHODS: The cytokine regulating immune-expressed genes (CRIEG) were sorted from literature and the GEO microarray dataset. Their co-differentially expressed miRNA and transcription factors were predicted from publicly available databases. Enrichment analysis was done through mienturnet, MiEAA, Gene Ontology, and pathways predicted by KEGG and Reactome pathways. Finally, the functional and regulatory features were analyzed and visualized through Cytoscape. RESULTS: Sixteen CRIEG were observed to have a significant protein-protein interaction network. The ontological analysis revealed significantly enriched pathways for biological processes, molecular functions, and cellular components. The search performed in the miRNA database yielded ten miRNAs that are significantly involved in regulating these genes and their transcription factors. CONCLUSION: An in-silico representation of a network involving miRNAs, CRIEGs, and TF, which take part in the inflammatory response in COVID-19, has been elucidated. Thus, these regulatory factors may have potentially critical roles in the inflammatory response in COVID-19 and may be explored further to develop targeted therapeutic strategies and mechanistic validation.

13.
J Mol Biol ; 433(10): 166946, 2021 05 14.
Article in English | MEDLINE | ID: covidwho-1386061

ABSTRACT

Coronaviruses are a major infectious disease threat, and include the zoonotic-origin human pathogens SARS-CoV-2, SARS-CoV, and MERS-CoV (SARS-2, SARS-1, and MERS). Entry of coronaviruses into host cells is mediated by the spike (S) protein. In our previous ESR studies, the local membrane ordering effect of the fusion peptide (FP) of various viral glycoproteins including the S of SARS-1 and MERS has been consistently observed. We previously determined that the sequence immediately downstream from the S2' cleavage site is the bona fide SARS-1 FP. In this study, we used sequence alignment to identify the SARS-2 FP, and studied its membrane ordering effect. Although there are only three residue differences, SARS-2 FP induces even greater membrane ordering than SARS-1 FP, possibly due to its greater hydrophobicity. This may be a reason that SARS-2 is better able to infect host cells. In addition, the membrane binding enthalpy for SARS-2 is greater. Both the membrane ordering of SARS-2 and SARS-1 FPs are dependent on Ca2+, but that of SARS-2 shows a greater response to the presence of Ca2+. Both FPs bind two Ca2+ ions as does SARS-1 FP, but the two Ca2+ binding sites of SARS-2 exhibit greater cooperativity. This Ca2+ dependence by the SARS-2 FP is very ion-specific. These results show that Ca2+ is an important regulator that interacts with the SARS-2 FP and thus plays a significant role in SARS-2 viral entry. This could lead to therapeutic solutions that either target the FP-calcium interaction or block the Ca2+ channel.


Subject(s)
Calcium/metabolism , Cell Membrane/metabolism , SARS Virus/metabolism , SARS-CoV-2/metabolism , Spike Glycoprotein, Coronavirus/metabolism , Viral Fusion Proteins/metabolism , Amino Acid Sequence , Binding Sites , Calcium/pharmacology , Calorimetry , Cell Membrane/drug effects , Cell Membrane/virology , Hydrogen-Ion Concentration , Hydrophobic and Hydrophilic Interactions , SARS Virus/drug effects , SARS-CoV-2/drug effects , Spike Glycoprotein, Coronavirus/chemistry , Spike Glycoprotein, Coronavirus/genetics , Thermodynamics , Viral Fusion Proteins/chemistry , Viral Fusion Proteins/genetics , Virus Internalization/drug effects
14.
Trials ; 22(1): 514, 2021 Aug 03.
Article in English | MEDLINE | ID: covidwho-1339146

ABSTRACT

OBJECTIVES: The current randomized controlled trial (RCT) will be conducted to assess the effect of green tea intake on disease symptoms and laboratory parameters including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and complete blood count (CBC) in patients with mild-to-moderate Covid-19 infection. TRIAL DESIGN: Randomized, double-blinded, parallel (1:1 ratio) clinical trial exploratory study PARTICIPANTS: We will recruit patients with COVID-19 infection admitted to Yasuj Shahid Jalil Hospital in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. Participants' inclusion criteria are as follows: Inclusion Criteria Patients aged ≥18 years COVID-19 diagnosis according to real-time polymerase chain reaction (RT-PCR) Exclusion Criteria Pregnancy or lactation Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive kidney failure Having a history of participating in a clinical trial during the last 30 days INTERVENTION AND COMPARATOR: Intervention: Two capsules containing 450 mg green tea extract along with routine treatment for COVID-19 patients in the intervention group. Two capsules containing placebo plus routine treatment for patients with COVID-19 infection. Capsules will be taken twice a day, after lunch and dinner, for 14 days. MAIN OUTCOMES: Changes in disease symptoms and laboratory parameters including CRP, ESR, and CBC after 14 days of the intervention compared to control group. RANDOMISATION: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 10, and patients in the intervention and control groups will be matched according to sex and age categories. Randomization will be done using computer-generated random numbers ( Randomization.com ) BLINDING (MASKING): The appearance of placebo and green tea capsules will be similar in terms of shape and color, and they will be packed in the same bags that will be prepared by the company. Also, the researcher and all participants will not be aware of the divisions until the end of the study. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): The total sample was determined based on CRP MCID in which high CRP levels were considered >2.6 mg/L. Accordingly, a total sample size of 37 patients for each intervention group was required. TRIAL STATUS: The protocol is Version 1.0, on June 5, 2021. Recruitment will start on July 11, 2021, which is anticipated to be completed by September 21, 2021. TRIAL REGISTRATION: IRCT20150711023153N3 ( https://www.irct.ir/trial/55948 ) retrospectively registered on June 4, 2021 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 was eliminated; this Letter serves as a summary of the key elements of the full protocol.


Subject(s)
COVID-19 , Adolescent , Adult , Female , Humans , Iran , Laboratories , Randomized Controlled Trials as Topic , SARS-CoV-2 , Tea , Treatment Outcome
15.
Comput Struct Biotechnol J ; 19: 3640-3649, 2021.
Article in English | MEDLINE | ID: covidwho-1272373

ABSTRACT

Severity prediction of COVID-19 remains one of the major clinical challenges for the ongoing pandemic. Here, we have recruited a 144 COVID-19 patient cohort, resulting in a data matrix containing 3,065 readings for 124 types of measurements over 52 days. A machine learning model was established to predict the disease progression based on the cohort consisting of training, validation, and internal test sets. A panel of eleven routine clinical factors constructed a classifier for COVID-19 severity prediction, achieving accuracy of over 98% in the discovery set. Validation of the model in an independent cohort containing 25 patients achieved accuracy of 80%. The overall sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 0.70, 0.99, 0.93, and 0.93, respectively. Our model captured predictive dynamics of lactate dehydrogenase (LDH) and creatine kinase (CK) while their levels were in the normal range. This model is accessible at https://www.guomics.com/covidAI/ for research purpose.

16.
Comput Struct Biotechnol J ; 19: 2833-2850, 2021.
Article in English | MEDLINE | ID: covidwho-1240272

ABSTRACT

The worldwide health crisis caused by the SARS-Cov-2 virus has resulted in>3 million deaths so far. Improving early screening, diagnosis and prognosis of the disease are critical steps in assisting healthcare professionals to save lives during this pandemic. Since WHO declared the COVID-19 outbreak as a pandemic, several studies have been conducted using Artificial Intelligence techniques to optimize these steps on clinical settings in terms of quality, accuracy and most importantly time. The objective of this study is to conduct a systematic literature review on published and preprint reports of Artificial Intelligence models developed and validated for screening, diagnosis and prognosis of the coronavirus disease 2019. We included 101 studies, published from January 1st, 2020 to December 30th, 2020, that developed AI prediction models which can be applied in the clinical setting. We identified in total 14 models for screening, 38 diagnostic models for detecting COVID-19 and 50 prognostic models for predicting ICU need, ventilator need, mortality risk, severity assessment or hospital length stay. Moreover, 43 studies were based on medical imaging and 58 studies on the use of clinical parameters, laboratory results or demographic features. Several heterogeneous predictors derived from multimodal data were identified. Analysis of these multimodal data, captured from various sources, in terms of prominence for each category of the included studies, was performed. Finally, Risk of Bias (RoB) analysis was also conducted to examine the applicability of the included studies in the clinical setting and assist healthcare providers, guideline developers, and policymakers.

18.
J Med Virol ; 93(7): 4532-4536, 2021 07.
Article in English | MEDLINE | ID: covidwho-1172352

ABSTRACT

Coronavirus disease 2019 (COVID-19) is caused by a contagious virus that has spread to more than 200 countries, territories, and regions. Thousands of studies to date have examined all aspects of this disease, yet little is known about the postrecovery status of patients, especially in the long term. Here, we examined erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and serum albumin biomarkers in patients with a history of severe and mild-to-moderate COVID-19 following their recovery. In patients with severe COVID-19 serum albumin had a strong negative correlation with both ESR and CRP levels (R2 = - 0.861 and R2 = - 0.711), respectively. Also, there was a positive correlation between ESR and CRP level (R2 = 0.85) in the same group. However, there was no correlation between these biomarkers among mild-to-moderate COVID-19 patients. In addition, no correlation was recorded between the severe and mild-to-moderate COVID-19 groups. This finding highlights the sustained elevation of ESR and CRP level and reduced serum albumin level that may persist postrecovery in patients with a history of severe COVID-19.


Subject(s)
Blood Sedimentation , C-Reactive Protein/analysis , COVID-19/blood , Hypoalbuminemia/blood , Serum Albumin/analysis , Biomarkers/blood , COVID-19/pathology , Humans , SARS-CoV-2/isolation & purification , Severity of Illness Index
19.
Trials ; 22(1): 246, 2021 Apr 02.
Article in English | MEDLINE | ID: covidwho-1166928

ABSTRACT

OBJECTIVES: This study is conducted to investigate efficacy of pomegranate juice on inflammatory biomarkers, C-reactive protein (CRP), interleukin 6(IL-6), erythrocyte sedimentation rate (ESR) and complete blood count (CBC) in hospitalized patients with mild to moderate coronavirus disease 2019 (COVID- 19). TRIAL DESIGN: This is a randomized, placebo-controlled, double-blind, parallel 2-arm (1:1 ratio) clinical trial. PARTICIPANTS: Patients with COVID-19 admitted to hospitals in Yasuj City, Kohgiluyeh and Boyer-Ahmad Province, Iran. INCLUSION CRITERIA: Informed consent Patients 18 years of age or older Diagnosis of COVID-19 based on real-time polymerase chain reaction (RT-PCR) test EXCLUSION CRITERIA: Pregnancy or lactation Immunoglobulin A (IgA) level <61 mg/dl Disseminated intravascular coagulation or any other types of coagulopathy Severe congestive heart failure Participation in any clinical trial within 30 days prior to enrollment in this RCT Other contraindications determined by the specialist. INTERVENTION AND COMPARATOR: Intervention: 500 ml pomegranate juice and standard of care hospital treatment for COVID-19 Comparator: matching placebo containing 500 ml of red water and standard of care hospital treatment for COVID-19 Both intervention and comparator to be taken twice a day, after lunch and dinner, for 14 days. CRITERIA FOR DISCONTINUING: Transfer of patients to intensive care unit (ICU) Death Unwillingness to continue participating in the study MAIN OUTCOMES: The main outcomes of this study are levels of inflammatory biomarkers, CRP, IL-6, ESR, and CBC after 14 days of treatment. RANDOMIZATION: Eligible patients will be randomly assigned into the intervention or control group in a 1:1 ratio. Randomization will be performed based on 8 permuted blocks with block sizes of 6 and they will be stratified according to sex and age categories. Randomization sequences will be prepared by the trial's pharmacist using computer-generated random numbers. BLINDING (MASKING): This study is a double-blind clinical trial (participant, researcher). The pomegranate juice and placebo juice are packaged in identical bottles, and the researcher and all the patients will be unaware of the study assignment until the end of the study. To ensure blinding, the randomization sequences will be kept in identical, opaque, sealed, and sequentially numbered envelopes. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE): The calculated total sample size is 48 patients, with 24 patients assigned into each group. TRIAL STATUS: The protocol is Version 1.0, on March 3, 2021. Recruitment started on February 28, 2021, and is anticipated to be completed by May 21, 2021. TRIAL REGISTRATION: The Name of registering trial Effects of Pomegranate Juice (Punica Granatum) on Inflammatory Biomarkers and CBC in Patients with COVID-19: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Iranian registry of clinical trials (IRCT) Registration Number: IRCT20150711023153N2 Date of Trial Registration February 28, 2021, retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials҆ website (Additional file 1). In the interest of 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)
COVID-19/therapy , Fruit and Vegetable Juices , Pomegranate , Randomized Controlled Trials as Topic , Blood Cell Count , Blood Sedimentation , C-Reactive Protein/immunology , COVID-19/blood , COVID-19/immunology , Double-Blind Method , Hospitalization , Humans , Interleukin-6/immunology , SARS-CoV-2
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