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2.
Journal of Cardiovascular Disease Research (Journal of Cardiovascular Disease Research) ; 14(4):150-156, 2023.
Article in English | Academic Search Complete | ID: covidwho-2325725

ABSTRACT

Background: Evaluation of the diagnostic accuracy of Modified Alvarado and Tzanakis scores in diagnosing Acute Appendicitis. Materials & methods: Due to COVID-19 pandemic the sample size was selected to be 51. CECT abdomen was done. Postoperatively, the Modified Alvarado and Tzanakis scoring systems were applied on all these patients using scoring sheets keeping a cut off of 7 for the Modified Alvarado score, and 8 for the Tzanakis score followed by which, histopathological diagnosis of the removed appendix was obtained. Subsequently, comparison was made between the histopathological findings and the above calculated scores. Data were analysed using SPSS version 23. Qualitative data was compared using Chi-square test or Fischer exact test as applicable. Results: The reported sensitivity and specificity for modified Alvarado score was 97.6% and 66.7% respectively while for Tzanakis scoring was reported as 92.9% and 100% respectively. Positive predictive value for modified Alvarado score was 93.2 with a negative predictive value of 85.6% and a diagnostic accuracy of 92.1%. Positive predictive value for Tzanakis score was 100% with a negative predictive value of 75.1% and a diagnostic accuracy of 94.2%. Conclusion: Tzanakis scoring system is an effective modality to establish the accurate diagnosis of acute appendicitis which requires surgery especially in low resource areas and helps in reducing the rates of negative appendicectomy. Though acute appendicitis is a clinical diagnosis the scoring system can complement the clinical diagnosis. [ FROM AUTHOR] Copyright of Journal of Cardiovascular Disease Research (Journal of Cardiovascular Disease Research) is the property of Journal of Cardiovascular Disease Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

3.
Journal of Food Biochemistry. ; 46(12):Not Available, 2023.
Article in English | EuropePMC | ID: covidwho-2325476

ABSTRACT

Nutraceuticals have emerged as potential compounds to attenuate the COVID‐19 complications. Precisely, these food additives strengthen the overall COVID treatment and enhance the immunity of a person. Such compounds have been used at a large scale, in almost every household due to their better affordability and easy access. Therefore, current research is focused on developing newer advanced formulations from potential drug candidates including nutraceuticals with desirable properties viz, affordability, ease of availability, ease of administration, stability under room temperature, and potentially longer shelf‐lives. As such, various nutraceutical‐based products such as compounds could be promising agents for effectively managing COVID‐19 symptoms and complications. Most importantly, regular consumption of such nutraceuticals has been shown to boost the immune system and prevent viral infections. Nutraceuticals such as vitamins, amino acids, flavonoids like curcumin, and probiotics have been studied for their role in the prevention of COVID‐19 symptoms such as fever, pain, malaise, and dry cough. In this review, we have critically reviewed the potential of various nutraceutical‐based therapeutics for the management of COVID‐19. We searched the information relevant to our topic from search engines such as PubMed and Scopus using COVID‐19, nutraceuticals, probiotics, and vitamins as a keyword. Any scientific literature published in a language other than English was excluded. PRACTICAL APPLICATIONS: Nutraceuticals possess both nutritional values and medicinal properties. They can aid in the prevention and treatment of diseases, as well as promote physical health and the immune system, normalizing body functions, and improving longevity. Recently, nutraceuticals such as probiotics, vitamins, polyunsaturated fatty acids, trace minerals, and medicinal plants have attracted considerable attention and are widely regarded as potential alternatives to current therapeutic options for the effective management of various diseases, including COVID‐19.

4.
PLoS One ; 18(4): e0279326, 2023.
Article in English | MEDLINE | ID: covidwho-2304121

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron subvariants are expected to be resistant to Bebtelovimab (BEB) monoclonal antibody (MAb) and the real-world experience regarding its effectiveness is scarce. This retrospective cohort study reports a data analysis in Banner Healthcare System (a large not-for-profit organization) between 4/5/2022 and 8/1/2022 and included 19,778 Coronavirus disease-19 (COVID-19) positive (by PCR or direct antigen testing) patients who were selected from Cerner-Electronic Health Record after the exclusions criteria were met. The study index date for cohort was determined as the date of BEB MAb administration or the date of the first positive COVID-19 testing. The cohort consist of COVID-19 infected patients who received BEB MAb (N = 1,091) compared to propensity score (PS) matched control (N = 1,091). The primary composite outcome was the incidence of 30-day all-cause hospitalization and/or mortality. All statistical analyses were conducted on the paired (matched) dataset. For the primary composite outcome, the event counts and percentages were reported. Ninety-five percent Clopper-Pearson confidence intervals for percentages were computed. The study cohorts were 1:1 propensity matched without replacement across 26 covariates using an optimal matching algorithm that minimizes the sum of absolute pairwise distance across the matched sample after fitting and using logistic regression as the distance function. The pairs were matched exactly on patient vaccination status, BMI group, age group and diabetes status. Compared to the PS matched control group (2.6%; 95% confidence interval [CI]: 1.7%, 3.7%), BEB MAb use (2.2%; 95% CI: 1.4%, 3.3%) did not significantly reduce the incidence of the primary outcome (p = 0.67). In the subgroup analysis, we observed similar no-difference trends regarding the primary outcomes for the propensity rematched BEB MAb treated and untreated groups, stratified by patient vaccination status, age (<65 years or ≥65), and immunocompromised status (patients with HIV/AIDS or solid organ transplants or malignancy including lymphoproliferative disorder). The number needed to treat (1/0.026-0.022) with BEB MAb was 250 to avoid one hospitalization and/or death over 30 days. The BEB MAb use lacked efficacy in patients with SARS-CoV-2 Omicron subvariants (mainly BA.2, BA.2.12.1, and BA.5) in the Banner Healthcare System in the Southwestern United States.


Subject(s)
COVID-19 , SARS-CoV-2 , Humans , Aged , COVID-19 Testing , Retrospective Studies , Antibodies, Monoclonal/therapeutic use
6.
Altern Ther Health Med ; 2022 Feb 25.
Article in English | MEDLINE | ID: covidwho-2290984

ABSTRACT

CONTEXT: Lymphopenia has been frequently documented and linked to coronavirus disease 2019 (COVID-19) in a severe acute respiratory syndrome (SARS)-coronavirus 2 (CoV-2) attack. A decrease in the T-lymphocyte count has shown promise as a clinical indicator and predictor of COVID-19 severity. OBJECTIVE: The review intended to examine the relationship of COVID-19 infections in individuals to lost expression of CD28 on naive CD4+/CD8+-mediated, vaccine-specific, neutralizing antibody responses. DESIGN: The research team performed a narrative review by searching eight databases: Medline, Elsevier, Cochrane, PubMed, Google Scholar, Mendeley, and Springer Nature. The search used the following key terms: SARS CoV-2, clinical aspects and pathology of SARS CoV-2, involvement of viral spike (S) protein in SARS CoV-2, immunological changes in COVID-19 infection, basic overview of CD28 immuno-molecule ligand, reduction of vaccine therapeutic efficacy in COVID-19 infection, and immunomodulatory response of lost CD28 ligand. SETTING: This study was done in a Maharishi Arvind College of Pharmacy, Jaipur, India. RESULTS: In COVID-19 patients, particularly those with severe disease, had increased levels of IL-2 or IL-2R. Given IL-2's supportive role in the expansion and differentiation of T cells, the authors exhibiting that lymphopenia, particularly in severe COVID-19, could be attributed to nonfunctional and dysfunctional differentiation of CD4+ and CD8+ T cells as a result of low CD28 immuno-molecule expression on naive T cells. CONCLUSIONS: The literature review found that independent, early immunological prognostic markers for a poor prognosis, in addition to higher levels of IL-6, include a substantial proportion of large inflammatory monocytes and a small proportion of chronic CD28+ CD4+T cells. The current findings suggest that a combination of COVID-19 vaccination with SARS CoV-2-reactive naive T cells with the CD28 immune-molecule may be a viable method for establishing T-cell-based, adaptive cellular immunotherapy against COVID-19 infection. Further research is needed, especially larger studies to confirm the current findings, to improve early clinical treatment.

8.
Natl Acad Sci Lett ; : 1-8, 2023 Mar 23.
Article in English | MEDLINE | ID: covidwho-2265739

ABSTRACT

To determine the cardiopulmonary changes in the survivors of acute COVID-19 infection at 3-6 month and 6-12 month. We followed up 53 patients out of which 28 (52%) had mild COVID-19 and 25 (48%) had severe COVID-19. The first follow-up was between 3 month after diagnosis up to 6 month and second follow-up between 6 and 12 month from the date of diagnosis of acute COVID-19. They were monitored using vital parameters, pulmonary function tests, echocardiography and a chest computed tomography (CT) scan. We found improvement in diffusing capacity for carbon monoxide (DLCO) with a median of 52% of predicted and 80% of predicted at the first and second follow-up, respectively. There was improvement in the CTSS in severe group from 22 (18-24) to 12 (10-18; p-0.001). Multivariable logistic regression revealed increased odds of past severe disease with higher CTSS at follow-up (OR-1.7 [CI 1.14-2.77]; P = 0.01). Correlation was found between CTSS and DLCO at second follow-up (r2 = 0.36; p < 0.01). Most of patients recovered from COVID-19 but a subgroup of patients continued to have persistent radiological and pulmonary function abnormalities necessitating a structured follow-up.

10.
Chem Biol Interact ; 368: 110231, 2022 Dec 01.
Article in English | MEDLINE | ID: covidwho-2250366

ABSTRACT

The human microbiota is fundamental to correct immune system development and balance. Dysbiosis, or microbial content alteration in the gut and respiratory tract, is associated with immune system dysfunction and lung disease development. The microbiota's influence on human health and disease is exerted through the abundance of metabolites produced by resident microorganisms, where short-chain fatty acids (SCFAs) represent the fundamental class. SCFAs are mainly produced by the gut microbiota through anaerobic fermentation of dietary fibers, and are known to influence the homeostasis, susceptibility to and outcome of many lung diseases. This article explores the microbial species found in healthy human gastrointestinal and respiratory tracts. We investigate factors contributing to dysbiosis in lung illness, and the gut-lung axis and its association with lung diseases, with a particular focus on the functions and mechanistic roles of SCFAs in these processes. The key focus of this review is a discussion of the main metabolites of the intestinal microbiota that contribute to host-pathogen interactions: SCFAs, which are formed by anaerobic fermentation. These metabolites include propionate, acetate, and butyrate, and are crucial for the preservation of immune homeostasis. Evidence suggests that SCFAs prevent infections by directly affecting host immune signaling. This review covers the various and intricate ways through which SCFAs affect the immune system's response to infections, with a focus on pulmonary diseases including chronic obstructive pulmonary diseases, asthma, lung cystic fibrosis, and tuberculosis. The findings reviewed suggest that the immunological state of the lung may be indirectly influenced by elements produced by the gut microbiota. SCFAs represent valuable potential therapeutic candidates in this context.


Subject(s)
Asthma , Gastrointestinal Microbiome , Humans , Dysbiosis/metabolism , Fatty Acids, Volatile/metabolism , Fatty Acids, Volatile/therapeutic use , Lung/metabolism , Asthma/drug therapy
11.
Int J Rheum Dis ; 2022 Oct 29.
Article in English | MEDLINE | ID: covidwho-2238811

ABSTRACT

COVID-19 remains a life-threatening infectious disease worldwide. Several bio-active agents have been tested and evaluated in an effort to contain this disease. Unfortunately, none of the therapies have been successful, owing to their safety concerns and the presence of various adverse effects. Various countries have developed vaccines as a preventive measure; however, they have not been widely accepted as effective strategies. The virus has proven to be exceedingly contagious and lethal, so finding an effective treatment strategy has been a top priority in medical research. The significance of vitamin D in influencing many components of the innate and adaptive immune systems is examined in this study. This review aims to summarize the research on the use of vitamin D for COVID-19 treatment and prevention. Vitamin D supplementation has now become an efficient option to boost the immune response for all ages in preventing the spread of infection. Vitamin D is an immunomodulator that treats infected lung tissue by improving innate and adaptive immune responses and downregulating the inflammatory cascades. The preventive action exerted by vitamin D supplementation (at a specific dose) has been accepted by several observational research investigations and clinical trials on the avoidance of viral and acute respiratory dysfunctions. To assess the existing consensus about vitamin D supplementation as a strategy to treat and prevent the development and progression of COVID-19 disease, this review intends to synthesize the evidence around vitamin D in relation to COVID-19 infection.

12.
Curr Opin Organ Transplant ; 2022 Nov 04.
Article in English | MEDLINE | ID: covidwho-2237192

ABSTRACT

PURPOSE OF REVIEW: The advent of calcineurin inhibitors have led to a significant improvement in short term outcomes after kidney transplantation. However, long term outcomes are hindered by the cardiovascular, metabolic and chronic renal toxicity associated with these agents. Belatacept is a selective T cell costimulation blocker that is approved for prevention of rejection in kidney transplantation, and has been associated with favorable cardiovascular, metabolic and renal outcomes in kidney transplant recipients. This review provides an overview of recent updates in the use of belatacept in kidney transplant recipients. RECENT FINDINGS: Belatacept may be a safe alternative to calcineurin inhibitors for select kidney transplant populations. Patients converted to belatacept from a calcineurin inhibitor-based immunosuppression generally experience improvement in renal function, and may be less likely to develop de novo donor specific antibodies or new onset diabetes after transplantation. Although, belatacept based immunosuppression may increase the risk of early acute cellular rejection, it may however be beneficial in stabilization of long-term renal function and improvement in inflammation in patients with chronic active antibody mediated rejection. These benefits need to be counterweighed with risks of lack of response to severe acute respiratory syndrome coronavirus 2 vaccination and other adverse infectious outcomes. SUMMARY: Belatacept may be an alternative to calcineurin inhibitors and may contribute to improved long term metabolic and allograft outcomes in kidney transplant recipients. Careful selection of patients for belatacept-based immunosuppression is needed, to obviate the risk of acute rejection shown in clinical studies.

14.
Eur J Radiol Open ; 9: 100451, 2022.
Article in English | MEDLINE | ID: covidwho-2178334

ABSTRACT

Background: We conducted this study to assess the diagnostic test properties of point of care ultrasonography (POCUS) of lung and cardiovascular system in prediction of mortality in COVID-19 patients. Methods: This is a cross-sectional study of 178 Covid-19 patients; POCUS was performed within one hour of admission to the ICU. We estimated sensitivity, specificity, positive predictive value, negative predictive value for prediction of mortality. Results: The mean (SD) age of these patients was 57.3 (12.8) years. The findings were on cardiac ultrasonography were: mild pericardial effusion (45%), chamber dilatation (15%), hypokinesia (11%), and low ejection fraction (8%). In our study, 30 patients (17%) had died. A cut-off score of > to 13 (for lung ultrasound score [LUS]) had high sensitivity for mortality (93.3%, 95% CI: 77.9-99.2%). However, low ejection fraction (92.3%, 95% CI: 86,6-96.1%), and thrombosis in either vein (96.5%, 95% CI: 92.0-98.9%) were specific for mortality. A combination of LUS > =13 or low ejection fraction or thrombosis or spontaneous echo contrast (slow flow) improved sensitivity for mortality to 96.7% (95% CI: 82.8-99.9%). The agreement between LUS of > =13 and CT score of moderate/severe was 85.7% (95% CI: 62.8-100%). The interrater agreement between these two parameters was 0.82 (95% CI: 0.68, 0.97). Conclusions: Multi-organ POCUS is effective in diagnosis, prognosis, and management of COVID-19 patients. Rather than just lung ultrasound, clinicians should use multiorgan POCUS for early identification of severe lung involvement and thrombotic changes; it may help reduce mortality in these patients.

15.
Infect Dis Ther ; 11(6): 2205-2217, 2022 Dec.
Article in English | MEDLINE | ID: covidwho-2129460

ABSTRACT

INTRODUCTION: Universal coverage of vaccines alone cannot be relied upon to protect at-risk populations in lower- and middle-income countries against the impact of the coronavirus disease 2019 (COVID-19) pandemic and newer variants. Live vaccines, including Bacillus Calmette-Guérin (BCG), are being studied for their effectiveness in reducing the incidence and severity of COVID-19 infection. METHODS: In this multi-centre quadruple-blind, parallel assignment randomised control trial, 495 high-risk group adults (aged 18-60 years) were randomised into BCG and placebo arms and followed up for 9 months from the date of vaccination. The primary outcome was the difference in the incidence of COVID-19 infection at the end of 9 months. Secondary outcomes included the difference in the incidence of severe COVID-19 infections, hospitalisation rates, intensive care unit stay, oxygen requirement and mortality at the end of 9 months. The primary analysis was done on an intention-to-treat basis, while safety analysis was done per protocol. RESULTS: There was no significant difference in the incidence rates of cartridge-based nucleic acid amplification test (CB-NAAT) positive COVID-19 infection [odds ratio (OR) 1.08, 95% confidence interval (CI) 0.54-2.14] in the two groups, but the BCG arm showed a statistically significant decrease in clinically diagnosed (symptomatic) probable COVID-19 infections (OR 0.38, 95% CI 0.20-0.72). Compared with the BCG arm, significantly more patients developed severe COVID-19 pneumonia (CB-NAAT positive) and required hospitalisation and oxygen in the placebo arm (six versus none; p = 0.03). One patient belonging to the placebo arm required intensive care unit (ICU) stay and died. BCG had a protective efficacy of 62% (95% CI 28-80%) for likely symptomatic COVID-19 infection. CONCLUSIONS: BCG is protective in reducing the incidence of acute respiratory illness (probable symptomatic COVID-19 infection) and severity of the disease, including hospitalisation, in patients belonging to the high-risk group of COVID-19 infection, and the antibody response persists for quite a long time. A multi-centre study with a larger sample size will help to confirm the findings in this study. CLINICAL TRIALS REGISTRY: Clinical Trials Registry India (CTRI/2020/07/026668).


The Bacillus Calmette­Guérin (BCG) vaccine has been studied previously in several settings, including reducing childhood mortalities due to viral infections and induction of trained immunity and reducing upper respiratory tract infections and pneumonia in older adults. This multi-centre trial has tried to evaluate the efficacy of BCG revaccination in reducing the incidence and severity of COVID-19 infections in adults between 18 and 60 years of age belonging to the high-risk group owing to the presence of comorbidities including diabetes, chronic kidney disease, chronic liver disease and chronic lung diseases. A single dose of BCG vaccine produced significantly high titres of BCG antibodies lasting for six months. While there was no significant reduction in the incidence of COVID-19 infection, there was an 8.4% reduction in the incidence of symptomatic COVID-19 disease at the end of 9 months of follow-up. In addition, there were significantly fewer severe COVID-19 infections requiring hospital stay and oxygen support. However, the overall numbers of severe COVID-19 infections were low. Thus, the study shows that BCG can protect against symptomatic and severe COVID-19 disease. However, it might not reduce the incidence of new infections. The study results are significant for low- and middle-income countries without adequate coverage of primary doses of COVID-19 vaccination, let alone the booster doses. Future studies should evaluate the BCG vaccine's efficacy as a booster compared with routine COVID-19 vaccine boosters.

16.
European journal of radiology open ; 2022.
Article in English | EuropePMC | ID: covidwho-2102730

ABSTRACT

Background We conducted this study to assess the diagnostic test properties of point of care ultrasonography (POCUS) of lung and cardiovascular system in prediction of mortality in COVID-19 patients. Methods This is a cross-sectional study of 178 Covid-19 patients;POCUS was performed within one hour of admission to the ICU. We estimated sensitivity, specificity, positive predictive value, negative predictive value for prediction of mortality. Results The mean (SD) age of these patients was 57.3 (12.8) years. The findings were on cardiac ultrasonography were: mild pericardial effusion (45%), chamber dilatation (15%), hypokinesia (11%), and low ejection fraction (8%). In our study, 30 patients (17%) had died. A cut-off score of > to 13 (for lung ultrasound score [LUS]) had high sensitivity for mortality (93.3%, 95% CI: 77.9% to 99.2%). However, low ejection fraction (92.3%, 95% CI: 86,6% to 96.1%), and thrombosis in either vein (96.5%, 95% CI: 92.0% to 98.9%) were specific for mortality. A combination of LUS >=13 or low ejection fraction or thrombosis or spontaneous echo contrast (slow flow) improved sensitivity for mortality to 96.7% (95% CI: 82.8% to 99.9%). The agreement between LUS of >=13 and CT score of moderate/severe was 85.7% (95% CI: 62.8% to 100%). The interrater agreement between these two parameters was 0.82 (95% CI: 0.68, 0.97). Conclusions Multi-organ POCUS is effective in diagnosis, prognosis, and management of COVID-19 patients. Rather than just lung ultrasound, clinicians should use multiorgan POCUS for early identification of severe lung involvement and thrombotic changes;it may help reduce mortality in these patients.

17.
J Food Biochem ; : e14445, 2022 Oct 14.
Article in English | MEDLINE | ID: covidwho-2078554

ABSTRACT

Nutraceuticals have emerged as potential compounds to attenuate the COVID-19 complications. Precisely, these food additives strengthen the overall COVID treatment and enhance the immunity of a person. Such compounds have been used at a large scale, in almost every household due to their better affordability and easy access. Therefore, current research is focused on developing newer advanced formulations from potential drug candidates including nutraceuticals with desirable properties viz, affordability, ease of availability, ease of administration, stability under room temperature, and potentially longer shelf-lives. As such, various nutraceutical-based products such as compounds could be promising agents for effectively managing COVID-19 symptoms and complications. Most importantly, regular consumption of such nutraceuticals has been shown to boost the immune system and prevent viral infections. Nutraceuticals such as vitamins, amino acids, flavonoids like curcumin, and probiotics have been studied for their role in the prevention of COVID-19 symptoms such as fever, pain, malaise, and dry cough. In this review, we have critically reviewed the potential of various nutraceutical-based therapeutics for the management of COVID-19. We searched the information relevant to our topic from search engines such as PubMed and Scopus using COVID-19, nutraceuticals, probiotics, and vitamins as a keyword. Any scientific literature published in a language other than English was excluded. PRACTICAL APPLICATIONS: Nutraceuticals possess both nutritional values and medicinal properties. They can aid in the prevention and treatment of diseases, as well as promote physical health and the immune system, normalizing body functions, and improving longevity. Recently, nutraceuticals such as probiotics, vitamins, polyunsaturated fatty acids, trace minerals, and medicinal plants have attracted considerable attention and are widely regarded as potential alternatives to current therapeutic options for the effective management of various diseases, including COVID-19.

18.
Cureus ; 14(8): e27814, 2022 Aug.
Article in English | MEDLINE | ID: covidwho-2030310

ABSTRACT

Introduction The COVID-19 pandemic has been a major public health threat for the past three years. The RNA virus has been constantly evolving, changing the manifestations and progression of the disease. Some factors which impact the progression to severe COVID-19 or mortality include comorbidities such as diabetes mellitus, hypertension, and obesity. In this study, we followed a cohort of patients to evaluate the risk factors leading to severe manifestations and mortality from COVID-19. Methodology We conducted a prospective observational study of 589 COVID-19 patients to assess the risk factors associated with the severity and mortality of the disease. Results In our cohort, 83.5% were male, with a median age (p25, p75) of 39.71 (30-48) years. The most common comorbidities included diabetes mellitus (7.8%) and hypertension (7.9%). About 41.7% had an asymptomatic disease, and of the symptomatic, 45% were mild, 6% moderate, and 7% severe. The mortality rate was 4.1%. Risk factors for severity included breathlessness (p=0.02), leukocytosis (p=0.02), and deranged renal function (p=0.04). Risk factors for mortality included older age (p=0.04), anemia (p=0.02), and leukocytosis (p=0.02). Conclusions COVID-19 commonly leads to asymptomatic or mild illness. The major factors we found that were associated with severity include breathlessness at presentation, leukocytosis, and deranged renal functions. The factors associated with mortality include older age, anemia, and leukocytosis.

19.
BMJ Open ; 12(8): e061301, 2022 08 29.
Article in English | MEDLINE | ID: covidwho-2020051

ABSTRACT

INTRODUCTION: Presently, there are few population-level strategies to address SARS-CoV-2 infection except preventive measures such as vaccination. Micronutrient deficiency, particularly vitamin D and zinc deficiency, has been associated with dysregulated host responses, and may play an important role in COVID-19. METHODS AND ANALYSIS: We have designed a 2×2 factorial, randomised, double-blind, multi-centre placebo-controlled trial to evaluate the effect of vitamin D and zinc on COVID-19 outcomes in Maharashtra, India. COVID-19 positive individuals are recruited from hospitals in Mumbai and Pune. Participants are provided (1) vitamin D3 bolus (180 000 IU) maintained by daily dose of 2000 IU and/or (2) zinc gluconate (40 mg daily), versus placebo for 8 weeks. Participants undergo a detailed assessment at baseline and at 8 weeks, and are monitored daily in hospital or every 3 days after leaving the hospital to assess symptoms and other clinical measures. A final follow-up telephone call occurs 12 weeks post-enrolment to assess long-term outcomes. The primary outcome of the study is to time to recovery, defined as time to resolution of all of fever, cough and shortness of breath. Secondary outcomes include: duration of hospital stay, all-cause mortality, necessity of assisted ventilation, change in blood biomarker levels and individual symptoms duration. Participant recruitment commenced on April 2021. ETHICS AND DISSEMINATION: Ethical approval was obtained from institutional ethical committees of all participating institutions. The study findings will be presented in peer-reviewed medical journals. TRIAL REGISTRATION NUMBERS: NCT04641195, CTRI/2021/04/032593, HMSC (GOI)-2021-0060.


Subject(s)
COVID-19 , Dietary Supplements , Humans , India/epidemiology , Multicenter Studies as Topic , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome , Vitamin D/therapeutic use , Zinc/therapeutic use
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