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2.
Nutrients ; 13(12)2021 Dec 02.
Article in English | MEDLINE | ID: covidwho-1551616

ABSTRACT

A single-center, randomized, double-blind, placebo-controlled study was conducted in 72 volunteers who received a synergistic combination of yeast-based ingredients with a unique ß-1,3/1,6-glucan complex and a consortium of heat-treated probiotic Saccharomyces cerevisiae rich in selenium and zinc (ABB C1®) or placebo on the next day after getting vaccinated against influenza (Chiromas®) (n = 34) or the COVID-19 (Comirnaty®) (n = 38). The duration of treatment was 30 and 35 days for the influenza and COVID-19 vaccine groups, respectively. Mean levels of CD4+T cells increased from 910.7 at baseline to 1000.2 cells/µL after the second dose of the COVID-19 vaccine in the ABB C1® group, whereas there was a decrease from 1055.1 to 929.8 cells/µL in the placebo group. Changes of CD3+T and CD8+T lymphocytes showed a similar trend. In the COVID-19 cohort, the increases in both IgG and IgM were higher in the ABB C1® supplement than in the placebo group. Serum levels of selenium and zinc showed a higher increase in subjects treated with the active product than in those receiving placebo. No serious adverse events related to ABB C1® or tolerance issues were reported. The study findings validate the capacity of the ABB C1® product to stimulate trained immunity.


Subject(s)
COVID-19 Vaccines/administration & dosage , Dietary Supplements , Influenza Vaccines/administration & dosage , Saccharomyces cerevisiae , Selenium/administration & dosage , Zinc/administration & dosage , beta-Glucans/administration & dosage , Antibodies, Viral/immunology , CD4-Positive T-Lymphocytes/immunology , CD8-Positive T-Lymphocytes/immunology , COVID-19 Vaccines/immunology , Double-Blind Method , Female , Humans , Immunoglobulin G/immunology , Immunoglobulin M/immunology , Influenza Vaccines/immunology , Male , Middle Aged , Selenium/immunology , Zinc/immunology , beta-Glucans/immunology
3.
Nutrients ; 13(10)2021 Sep 25.
Article in English | MEDLINE | ID: covidwho-1438686

ABSTRACT

Food supplements (FS) are a concentrated source of vitamins, minerals, or other ingredients with nutritional or other physiological effects. Due to their easy availability, widespread advertising, and sometimes low price, increased consumption of this group of preparations has been observed. Therefore, the aim of the study was to assess the knowledge and intake of FS during the COVID-19 pandemic in Poland, with particular reference to FS containing zinc and vitamin D. It was noted that both of the above ingredients were used significantly more often by people with higher education (59.0%), with a medical background or related working in the medical field (54.5%), and/or exercising at home (60.1%). Preparations containing vitamin D were used by 22.8% of the respondents in the first wave, 37.6% in the second wave, and 32.9% in the third wave. To sum up, we showed the highest consumption of vitamin and mineral supplements, and preparations containing zinc and vitamin D were taken significantly more often by people with higher medical and related education. This indicates a high awareness of health aspects and the need for preventive measures in these groups.


Subject(s)
COVID-19/immunology , Dietary Supplements/statistics & numerical data , Health Behavior , Vitamin D/administration & dosage , Zinc/administration & dosage , Adult , Female , Humans , Male , Poland , SARS-CoV-2 , Trace Elements/administration & dosage , Trace Elements/immunology , Vitamin D/immunology , Vitamins/administration & dosage , Vitamins/immunology , Zinc/immunology
4.
Nutr Hosp ; 38(3): 622-630, 2021 Jun 10.
Article in English | MEDLINE | ID: covidwho-1264738

ABSTRACT

INTRODUCTION: Coronavirus disease 2019 (COVID-19) is caused by severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). Compared with adults, children with SARS-CoV-2 infection may have fewer and less severe symptoms. Gastrointestinal symptoms are commonly reported in children, sometimes as the only manifestation of the disease, and most often manifest as anorexia, diarrhea, nausea and vomiting, or abdominal pain. Although most children have asymptomatic or mild disease, 10 % of those infected may experience serious or critical disease, or even death. Multisystem inflammatory syndrome is a rare but serious condition recently reported in children with COVID-19. Studies indicate that children with obesity are at higher risk of developing severe COVID-19, and inflammation associated with obesity could be one of the factors that worsens COVID-19 symptoms due to an increased inflammatory response involving molecules such as interleukin 6, tumor necrosis factor alpha, and monocyte chemoattractant protein. On the other hand, evidence has been reported of a higher protein expression of ACE2 in the visceral adipose tissue of obese and malnourished humans, and this could be associated with complications and severity of COVID-19. Therefore, regulation of the intake of macronutrients or micronutrients could be used as a strategy to reduce the consequences of COVID-19. Diet in general and bioactive compounds could play an important role in the prevention of the inflammatory cascade. The micronutrients with the most evidence suggesting a role in immune support are vitamins C and D, zinc, and polyphenols.


INTRODUCCIÓN: La enfermedad por coronavirus 2019 (COVID-19) está causada por el virus "síndrome respiratorio agudo severo-coronavirus 2" (SARS-CoV-2). En comparación con los adultos, los niños con infección por SARS-CoV-2 pueden tener menos síntomas y estos pueden ser menos graves. Los síntomas gastrointestinales se informan comúnmente en los niños, a veces como única manifestación de la enfermedad. Los más comunes son anorexia, diarrea, náuseas y vómitos, y dolor abdominal. Aunque la mayoría de los niños tienen un cuadro leve o asintomático, el 10 % de los infectados pueden experimentar un cuadro grave o crítico, e incluso la muerte. El síndrome inflamatorio multisistémico es una afección poco común, pero grave, que se documentó recientemente en niños con COVID-19. Los estudios indican que los niños con obesidad tienen mayor riesgo de desarrollar COVID-19 grave, y la inflamación asociada con la obesidad podría ser uno de los factores que empeoran los síntomas de la COVID-19 debido a una respuesta inflamatoria aumentada en donde se ven involucradas moléculas como la interleucina 6, el factor de necrosis tumoral alfa y la proteína quimioatrayente de monocitos. Por otro lado, se ha encontrado evidencia de una mayor expresión proteica de ACE2 en el tejido adiposo visceral de los seres humanos obesos y desnutridos, y esto podría estar asociado a las complicaciones y la severidad de la COVID-19. Por tanto, la regulación de la ingesta de macronutrientes o micronutrientes podría utilizarse como estrategia para reducir las consecuencias de la enfermedad. La dieta en general y los compuestos bioactivos podrían desempeñar un papel importante en la prevención de la cascada inflamatoria. Los micronutrientes con mayor evidencia indicativa de que desempeñan un papel en el apoyo inmunológico son las vitaminas C y D, el zinc y los polifenoles.


Subject(s)
COVID-19/complications , Gastrointestinal Diseases/etiology , Pediatric Obesity/complications , Abdominal Pain/etiology , Angiotensin-Converting Enzyme 2/metabolism , Anorexia/etiology , Ascorbic Acid/administration & dosage , COVID-19/etiology , COVID-19/metabolism , Child , Diarrhea/etiology , Female , Humans , Inflammation/complications , Male , Nausea/etiology , Overweight/complications , Oxidative Stress , Pediatric Obesity/metabolism , Polyphenols/administration & dosage , Systemic Inflammatory Response Syndrome/etiology , Thinness/complications , Thinness/metabolism , Vitamin D/administration & dosage , Vitamins/administration & dosage , Vomiting/etiology , Zinc/administration & dosage , Zinc/deficiency
5.
J Med Virol ; 93(5): 3261-3267, 2021 May.
Article in English | MEDLINE | ID: covidwho-1206829

ABSTRACT

Zinc inhibits replication of the SARS-CoV virus. We aimed to evaluate the safety, feasibility, and biological effect of administering high-dose intravenous zinc (HDIVZn) to patients with COVID-19. We performed a Phase IIa double-blind, randomized controlled trial to compare HDIVZn to placebo in hospitalized patients with COVID-19. We administered trial treatment per day for a maximum of 7 days until either death or hospital discharge. We measured zinc concentration at baseline and during treatment and observed patients for any significant side effects. For eligible patients, we randomized and administered treatment to 33 adult participants to either HDIVZn (n = 15) or placebo (n = 18). We observed no serious adverse events throughout the study for a total of 94 HDIVZn administrations. However, three participants in the HDIVZn group reported infusion site irritation. Mean serum zinc on Day 1 in the placebo, and the HDIVZn group was 6.9 ± 1.1 and 7.7 ± 1.6 µmol/l, respectively, consistent with zinc deficiency. HDIVZn, but not placebo, increased serum zinc levels above the deficiency cutoff of 10.7 µmol/l (p < .001) on Day 6. Our study did not reach its target enrollment because stringent public health measures markedly reduced patient hospitalizations. Hospitalized COVID-19 patients demonstrated zinc deficiency. This can be corrected with HDIVZn. Such treatment appears safe, feasible, and only associated with minimal peripheral infusion site irritation. This pilot study justifies further investigation of this treatment in COVID-19 patients.


Subject(s)
COVID-19/drug therapy , SARS-CoV-2 , Zinc/therapeutic use , Adult , Aged , Aged, 80 and over , Dose-Response Relationship, Drug , Double-Blind Method , Feasibility Studies , Female , Humans , Injections, Intravenous , Inpatients , Male , Middle Aged , Oxygen/blood , Pilot Projects , Respiration, Artificial , Zinc/administration & dosage
6.
J Med Virol ; 93(5): 3176-3183, 2021 05.
Article in English | MEDLINE | ID: covidwho-1196542

ABSTRACT

This trial compared the rate and time of viral clearance in subjects receiving a combination of nitazoxanide, ribavirin, and ivermectin plus Zinc versus those receiving supportive treatment. This non-randomized controlled trial included 62 patients on the triple combination treatment versus 51 age- and sex-matched patients on routine supportive treatment. all of them confirmed cases by positive reverse-transcription polymerase chain reaction of a nasopharyngeal swab. Trial results showed that the clearance rates were 0% and 58.1% on the 7th day and 13.7% and 73.1% on the 15th day in the supportive treatment and combined antiviral groups, respectively. The cumulative clearance rates on the 15th day are 13.7% and 88.7% in the supportive treatment and combined antiviral groups, respectively. This trial concluded by stating that the combined use of nitazoxanide, ribavirin, and ivermectin plus zinc supplement effectively cleared the SARS-COV2 from the nasopharynx in a shorter time than symptomatic therapy.


Subject(s)
COVID-19/drug therapy , Ivermectin/therapeutic use , Nitro Compounds/therapeutic use , Ribavirin/therapeutic use , SARS-CoV-2 , Thiazoles/therapeutic use , Zinc/therapeutic use , Adult , Antimetabolites/administration & dosage , Antimetabolites/therapeutic use , Antiparasitic Agents/administration & dosage , Antiparasitic Agents/therapeutic use , Female , Humans , Ivermectin/administration & dosage , Male , Nitro Compounds/administration & dosage , Ribavirin/administration & dosage , Thiazoles/administration & dosage , Trace Elements/administration & dosage , Trace Elements/therapeutic use , Zinc/administration & dosage
7.
Nutrients ; 13(4)2021 Apr 12.
Article in English | MEDLINE | ID: covidwho-1178371

ABSTRACT

More than one year has passed since the first cases of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome (SARS)-CoV-2 coronavirus were reported in Wuhan (China), rapidly evolving into a global pandemic. This infectious disease has become a major public health challenge in the world. Unfortunately, to date, no specific antivirals have been proven to be effective against COVID-19, and although a few vaccines are available, the mortality rate is not decreasing but is still increasing. One therapeutic strategy has been focused on infection prevention and control measures. In this regard, the use of nutraceutical supports may play a role against some aspect of the infection, particularly the inflammatory state and the immune system function of patients, thus representing a strategy to control the worst outcomes of this pandemic. For this reason, we performed an overview including meta-analyses and systematic reviews to assess the association among melatonin, vitamin C, vitamin D, zinc supplementation and inflammatory markers using three databases, namely, MEDLINE, PubMed Central and the Cochrane Library of Systematic Reviews. According to the evidence available, an intake of 50,000 IU/month of vitamin D showed efficacy in CRP. An amount of 1 to 2 g per day of vitamin C demonstrated efficacy both in CRP and endothelial function, and a dosage of melatonin ranging from 5 to 25 mg /day showed good evidence of efficacy in CRP, TNF and IL6. A dose of 50 mg/day of elemental zinc supplementation showed positive results in CRP. Based on the data reported in this review, the public health system could consider whether it is possible to supplement the current limited preventive measures through targeted nutraceutical large-scale administration.


Subject(s)
Ascorbic Acid/administration & dosage , COVID-19/drug therapy , Dietary Supplements , Melatonin/administration & dosage , Vitamin D/administration & dosage , Zinc/administration & dosage , C-Reactive Protein/analysis , COVID-19/prevention & control , Humans , Immune System/drug effects , Inflammation/drug therapy , Meta-Analysis as Topic , SARS-CoV-2 , Trace Elements/administration & dosage , Vitamins/administration & dosage
8.
Inflammopharmacology ; 29(1): 101-105, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1100980

ABSTRACT

The nutritional status of a patient can be critical for the efficacy of other pharmaceuticals, especially organic antibiotics, to treat viral pandemics. There may be political and scientific difficulties in achieving a constructive synergy of nutritional and prescribed allopathic remedies. For adequate treatment, timelines may need to extend well beyond eliminating viral proliferation, e.g., with vaccines, to include the goals of (a) reducing post-viral fatigue, (b) promoting earliest recovery, and (c) future resistance in often poorly nourished patients, e.g., obese (!). Many trace minerals (TM) and vitamins may need to be replenished. This review focusses only upon zinc to illustrate some problems in rectifying these TM deficiencies affecting the balance between continued ill-health ('illth') or regaining optimal physical and mental wellbeing. Ultimately, this is a matter of behaviour, lifestyle, and informed choice(s). See Hetzel and McMichael 1959.


Subject(s)
Anti-Infective Agents/therapeutic use , COVID-19/drug therapy , Dietary Supplements , Nutritional Status , SARS-CoV-2 , Zinc/therapeutic use , Anti-Infective Agents/administration & dosage , Humans , Pandemics , Zinc/administration & dosage , Zinc/metabolism
9.
J Microbiol Immunol Infect ; 54(5): 997-1000, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1081399

ABSTRACT

Among 275 patients with COVID-19, we found that median blood zinc level was significantly lower in patients with poor clinical outcome (N = 75) as compared to patients with good clinical outcome (N = 200) (840 µg/L versus 970 µg/L; p < 0.0001), suggesting that zinc supplementation could be useful for patients with severe COVID-19.


Subject(s)
Antiviral Agents/therapeutic use , COVID-19/drug therapy , Dietary Supplements , SARS-CoV-2/drug effects , Zinc/administration & dosage , Zinc/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Azithromycin/therapeutic use , Chloroquine/therapeutic use , Female , Humans , Male , Middle Aged , Treatment Outcome , Young Adult
10.
Pan Afr Med J ; 37(Suppl 1): 42, 2020.
Article in English | MEDLINE | ID: covidwho-1069975

ABSTRACT

The aim of this study was to evaluate the main clinical and evolutionary features of SARS-CoV-2 infection in children aged 0-18 years who were suspected and diagnosed for COVID-19 during routine consultations in the pediatric ward of the Ignace Deen National Hospital in Conakry. This retrospective study targeted all children admitted to the Pediatrics Department during the study period and focused on children whose clinical examination and/or history indicated a suspicion of SARS-CoV-2 infection. Only children with a positive reverse transcriptase-polymerase chain reaction (RT-PCR) test were included. Clinical and paraclinical data were rigorously analyzed. Anonymity and respect for ethical rules were the norm. Medical records were used as the data source and a questionnaire was developed for collection. The analysis was done using STATA/SE version 11.2 software. The mean age of the patients observed was 9.66±1.32 years, with a sex ratio of 1.25. The history of the patients found that 36.11 had already been in contact with a COVID-19 positive subject, of which 8 or 22 had close relatives treated for COVID-19 and 5 had been with classmates treated for COVID-19. Fever and physical asthenia, runny nose and throat pain were respectively found in 58.33%, 50% and 30.55% of patients with irritability in 25%. Asymptomatic children were 30.55%. The diagnosis was confirmed after a positive RT-PCR test. Thoracic computed tomography (CT) scan was normal in 80.55% of the children. They were given mostly azithromycin 15mg/kg, zinc and chloroquine sulfate 5mg/kg. The mean age of the patients observed was 9.66 years, with a sex ratio of 1.25. The history of the patients found that 36.11 had already been in contact with a COVID-19 positive subject, of which 8 or 22 had close relatives treated for COVID-19 and 5 had been with classmates treated for COVID-19. Fever and physical asthenia, runny nose and throat pain were respectively found in 58.33%, 50% and 30.55% of patients with irritability in 25%. Asymptomatic children were 30.55%. The diagnosis was confirmed after a positive RT-PCR test. Thoracic computed tomography (CT) scan was normal in 80.55% of the children. They were given mostly azithromycin 15mg/kg, zinc and chloroquine sulfate 5mg/kg.


Subject(s)
Asymptomatic Infections/epidemiology , COVID-19 Testing , COVID-19/epidemiology , Hospitalization , Adolescent , Azithromycin/administration & dosage , COVID-19/diagnosis , COVID-19/physiopathology , Child , Child, Preschool , Chloroquine/administration & dosage , Female , Guinea , Humans , Infant , Male , Retrospective Studies , Reverse Transcriptase Polymerase Chain Reaction , Tomography, X-Ray Computed , Zinc/administration & dosage
11.
Nutrients ; 13(2)2021 Feb 09.
Article in English | MEDLINE | ID: covidwho-1069852

ABSTRACT

BACKGROUND: Zinc is an essential micronutrient that impacts host-pathogen interplay at infection. Zinc balances immune responses, and also has a proven direct antiviral action against some viruses. Importantly, zinc deficiency (ZD) is a common condition in elderly and individuals with chronic diseases, two groups with an increased risk for severe severe coronavirus disease 2019 (COVID-19) outcomes. We hypothesize that serum zinc content (SZC) influences COVID-19 disease progression, and thus might represent a useful biomarker. METHODS: We ran an observational cohort study with 249 COVID-19 patients admitted in Hospital del Mar. We have studied COVID-19 severity and progression attending to SZC at admission. In parallel, we have studied severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) replication in the Vero E6 cell line modifying zinc concentrations. FINDINGS: Our study demonstrates a correlation between serum zinc levels and COVID-19 outcome. Serum zinc levels lower than 50 µg/dL at admission correlated with worse clinical presentation, longer time to reach stability, and higher mortality. Our in vitro results indicate that low zinc levels favor viral expansion in SARS-CoV-2 infected cells. INTERPRETATION: Low SZC is a risk factor that determines COVID-19 outcome. We encourage performing randomized clinical trials to study zinc supplementation as potential prophylaxis and treatment with people at risk of zinc deficiency.


Subject(s)
COVID-19/blood , COVID-19/pathology , SARS-CoV-2 , Zinc/blood , Aged , Animals , Cell Survival , Chlorocebus aethiops , Cohort Studies , Female , Humans , Male , Middle Aged , Vero Cells , Zinc/administration & dosage , Zinc/pharmacology
13.
J Food Biochem ; 45(2): e13604, 2021 02.
Article in English | MEDLINE | ID: covidwho-1032331

ABSTRACT

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the etiological agent for the Coronavirus Disease 2019 (COVID-19). The COVID-19 pandemic has created unimaginable and unprecedented global health crisis. Since the outbreak of COVID-19, millions of dollars have been spent, hospitalization overstretched with increasing morbidity and mortality. All these have resulted in unprecedented global economic catastrophe. Several drugs and vaccines are currently being evaluated, tested, and administered in the frantic efforts to stem the dire consequences of COVID-19 with varying degrees of successes. Zinc possesses potential health benefits against COVID-19 pandemic by improving immune response, minimizing infection and inflammation, preventing lung injury, inhibiting viral replication through the interference of the viral genome transcription, protein translation, attachment, and host infectivity. However, this review focuses on the various mechanisms of action of zinc and its supplementation as adjuvant for vaccines an effective therapeutic regimen in the management of the ravaging COVID-19 pandemic. PRACTICAL APPLICATIONS: The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiological agent for the Coronavirus Disease 2019 (COVID-19), has brought unprecedented untold hardship to both developing and developed countries. The global race for vaccine development against COVID-19 continues with success in sight with attendant increasing hospitalization, morbidity, and mortality. Available drugs with anti-inflammatory actions have become alternative to stem the tide of COVID-19 with attendant global financial crises. However, Zinc is known to modulate several physiological functions including intracellular signaling, enzyme function, gustation, and olfaction, as well as reproductive, skeletal, neuronal, and cardiovascular systems. Hence, achieving a significant therapeutic approach against COVID-19 could imply the use of zinc as a supplement together with available drugs and vaccines waiting for emergency authorization to win the battle of COVID-19. Together, it becomes innovative and creative to supplement zinc with currently available drugs and vaccines.


Subject(s)
COVID-19/drug therapy , Dietary Supplements , Pandemics , Zinc/administration & dosage , Anti-Inflammatory Agents/pharmacology , Antioxidants/pharmacology , Antiviral Agents/pharmacology , COVID-19/virology , Cytokine Release Syndrome/prevention & control , Genome, Viral , Humans , Immune System/drug effects , SARS-CoV-2/genetics , SARS-CoV-2/isolation & purification , Zinc/pharmacology
14.
PLoS Negl Trop Dis ; 15(1): e0008895, 2021 01.
Article in English | MEDLINE | ID: covidwho-1006366

ABSTRACT

A wide variety of symptoms is associated with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection, and these symptoms can overlap with other conditions and diseases. Knowing the distribution of symptoms across diseases and individuals can support clinical actions on timelines shorter than those for drug and vaccine development. Here, we focus on zinc deficiency symptoms, symptom overlap with other conditions, as well as zinc effects on immune health and mechanistic zinc deficiency risk groups. There are well-studied beneficial effects of zinc on the immune system including a decreased susceptibility to and improved clinical outcomes for infectious pathogens including multiple viruses. Zinc is also an anti-inflammatory and anti-oxidative stress agent, relevant to some severe Coronavirus Disease 2019 (COVID-19) symptoms. Unfortunately, zinc deficiency is common worldwide and not exclusive to the developing world. Lifestyle choices and preexisting conditions alone can result in zinc deficiency, and we compile zinc risk groups based on a review of the literature. It is also important to distinguish chronic zinc deficiency from deficiency acquired upon viral infection and immune response and their different supplementation strategies. Zinc is being considered as prophylactic or adjunct therapy for COVID-19, with 12 clinical trials underway, highlighting the relevance of this trace element for global pandemics. Using the example of zinc, we show that there is a critical need for a deeper understanding of essential trace elements in human health, and the resulting deficiency symptoms and their overlap with other conditions. This knowledge will directly support human immune health for decreasing susceptibility, shortening illness duration, and preventing progression to severe cases in the current and future pandemics.


Subject(s)
COVID-19/drug therapy , COVID-19/prevention & control , Zinc/administration & dosage , Zinc/deficiency , Anti-Inflammatory Agents/pharmacology , COVID-19/immunology , COVID-19/virology , Humans , Immune System/drug effects , Oxidative Stress/drug effects , Oxidative Stress/immunology , Pandemics , Risk Factors , SARS-CoV-2/isolation & purification
15.
BMJ Open ; 10(12): e040580, 2020 Dec 02.
Article in English | MEDLINE | ID: covidwho-955465

ABSTRACT

INTRODUCTION: SARS-CoV-2 (COVID-19) has caused an international pandemic of respiratory illness, resulting in significant healthcare and economic turmoil. To date, no robust vaccine or treatment has been identified. Elemental zinc has previously been demonstrated to have beneficial effects on coronaviruses and other viral respiratory infections due to its effect on RNA polymerase. Additionally, zinc has well-demonstrated protective effects against hypoxic injury-a clear mechanism of end-organ injury in respiratory distress syndrome. We aimed to assess the effect of high-dose intravenous zinc (HDIVZn) on SARS-CoV-2 infection. The end of study analyses will evaluate the reduction of impact of oxygen saturations or requirement of oxygen supplementation. METHODS AND ANALYSIS: We designed a double-blind randomised controlled trial of daily HDIVZn (0.5 mg/kg) versus placebo. Primary outcome measures are lowest oxygen saturation (or greatest level of supplemental oxygenation) for non-ventilated patients and worst PaO2/FiO2 for ventilated patients. Following power calculations, 60 hospitalised patients and 100 ventilated patients will be recruited to demonstrate a 20% difference. The duration of follow-up is up to the point of discharge. ETHICS AND DISSEMINATION: Ethical approval was obtained through the independent Human Research Ethics Committee. Participant recruitment will commence in May 2020. Results will be published in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER: ACTRN126200000454976.


Subject(s)
COVID-19/drug therapy , Zinc/administration & dosage , Administration, Intravenous , Adult , Clinical Trials, Phase II as Topic , Double-Blind Method , Female , Humans , Hypoxia/prevention & control , Male , Oxygen/blood , Pandemics , Randomized Controlled Trials as Topic , SARS-CoV-2 , Zinc/adverse effects
16.
Trials ; 21(1): 892, 2020 Oct 27.
Article in English | MEDLINE | ID: covidwho-895025

ABSTRACT

OBJECTIVES: The primary objectives of this study are to determine efficacy of Siddha medicine, Kabasura kudineer in reduction of SARS-CoV-2 viral load and reducing the onset of symptoms in asymptomatic COVID-19 when compared to Vitamin C and Zinc (CZ) supplementation. In addition, the trial will examine the changes in the immunological markers of the Siddha medicine against control. The secondary objectives of the trial are to evaluate the safety of the Siddha medicine and to document clinical profile of asymptomatic COVID-19 as per principles of Siddha system of Medicine. TRIAL DESIGN: A single centre, open-label, parallel group (1:1 allocation ratio), exploratory randomized controlled trial. PARTICIPANTS: Cases admitted at non-hospital settings designated as COVID Care Centre and managed by the State Government Stanley Medical College, Chennai, Tamil Nadu, India will be recruited. Eligible participants will be those tested positive for COVID-19 by Reverse Transcriptase Polymerase Chain reaction (RT-PCR) aged 18 to 55 years without any symptoms and co-morbidities like diabetes mellitus, hypertension and bronchial asthma. Those pregnant or lactating, with severe respiratory disease, already participating in COVID trials and with severe illness like malignancy will be excluded. INTERVENTION AND COMPARATOR: Adopting traditional methods, decoction of Kabasura kudineer will be prepared by boiling 5g of KSK powder in 240 ml water and reduced to one-fourth (60ml) and filtered. The KSK group will receive a dose of 60ml decoction, orally in the morning and evening after food for 14 days. The control group will receive Vitamin C (60000 IU) and Zinc tablets (100mg) orally in the morning and evening respectively for 14 days. MAIN OUTCOMES: The primary outcomes are the reduction in the SARS-CoV-2 load [as measured by cyclic threshold (CT) value of RT-PCR] from the baseline to that of seventh day of the treatment, prevention of progression of asymptomatic to symptomatic state (clinical symptoms like fever, cough and breathlessness) and changes in the immunity markers [Interleukins (IL) 6, IL10, IL2, Interferon gamma (IFNγ) and Tumor Necrosis Factor (TNF) alpha]. Clinical assessment of COVID-19 as per standard Siddha system of medicine principles and the occurrence of adverse effects will be documented as secondary outcomes. RANDOMISATION: The assignment to the study or control group will be allocated in equal numbers through randomization using random number generation in Microsoft Excel by a statistician who is not involved in the trial. The allocation scheme will be made by an independent statistician using a sealed envelope. The participants will be allocated immediately after the eligibility assessment and informed consent procedures. BLINDING (MASKING): This study is unblinded. The investigators will be blinded to data analysis, which will be carried out by a statistician who is not involved in the trial. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): Sample size could not be calculated, as there is no prior trial on KSK. This trial will be a pilot trial. Hence, we intend to recruit 60 participants in total using a 1:1 allocation ratio, with 30 participants randomised into each arm. TRIAL STATUS: Protocol version 2.0 dated 16th May 2020. Recruitment is completed. The trial started recruitment on the 25th May 2020. We anticipate study including data analysis will finish on November 2020. We also stated that protocol was submitted before the end of data collection TRIAL REGISTRATION: The study protocol was registered with clinical trial registry of India (CTRI) with CTRI/2020/05/025215 on 16 May 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. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).


Subject(s)
Ascorbic Acid , Betacoronavirus , Coronavirus Infections , Medicine, Ayurvedic/methods , Pandemics , Pneumonia, Viral , Zinc , Adult , Ascorbic Acid/administration & dosage , Ascorbic Acid/adverse effects , Asymptomatic Infections/therapy , Betacoronavirus/drug effects , Betacoronavirus/isolation & purification , COVID-19 , Coronavirus Infections/diagnosis , Coronavirus Infections/drug therapy , Dietary Supplements , Drug Monitoring/methods , Female , Humans , India , Male , Pneumonia, Viral/diagnosis , Pneumonia, Viral/drug therapy , Randomized Controlled Trials as Topic , SARS-CoV-2 , Treatment Outcome , Viral Load/methods , Zinc/administration & dosage , Zinc/adverse effects
17.
Int J Antimicrob Agents ; 56(6): 106214, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-893921

ABSTRACT

The aim of this study was to describe the outcomes of patients with coronavirus disease 2019 (COVID-19) in the outpatient setting after early treatment with zinc, low-dose hydroxychloroquine and azithromycin (triple therapy) dependent on risk stratification. This was a retrospective case series study in the general practice setting. A total of 141 COVID-19 patients with laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in the year 2020 were included. The main outcome measures were risk-stratified treatment decision and rates of hospitalisation and all-cause death. A median of 4 days [interquartile range (IQR) 3-6 days; available for n = 66/141 patients] after the onset of symptoms, 141 patients (median age 58 years, IQR 40-67 years; 73.0% male) received a prescription for triple therapy for 5 days. Independent public reference data from 377 confirmed COVID-19 patients in the same community were used as untreated controls. Of 141 treated patients, 4 (2.8%) were hospitalised, which was significantly fewer (P < 0.001) compared with 58 (15.4%) of 377 untreated patients [odds ratio (OR) = 0.16, 95% confidence interval (CI) 0.06-0.5]. One patient (0.7%) in the treatment group died versus 13 patients (3.4%) in the untreated group (OR = 0.2, 95% CI 0.03-1.5; P = 0.12). No cardiac side effects were observed. Risk stratification-based treatment of COVID-19 outpatients as early as possible after symptom onset using triple therapy, including the combination of zinc with low-dose hydroxychloroquine, was associated with significantly fewer hospitalisations.


Subject(s)
Azithromycin/administration & dosage , COVID-19/drug therapy , Hydroxychloroquine/administration & dosage , SARS-CoV-2 , Zinc/administration & dosage , Adolescent , Adult , Aged , Aged, 80 and over , Azithromycin/adverse effects , Drug Therapy, Combination , Female , Humans , Hydroxychloroquine/adverse effects , Male , Middle Aged , Outpatients , Retrospective Studies , Young Adult , Zinc/adverse effects
18.
Trop Anim Health Prod ; 52(2): 511-515, 2020 Mar.
Article in English | MEDLINE | ID: covidwho-829118

ABSTRACT

The current experiment was performed to find the potential effect of inorganic and organic forms of zinc (Zn) on growth, intestinal histomorphology, immune response, and paraoxonase (PON1) activity in broiler. In this experiment, a total of 450 broiler chickens were assigned to four experimental and control groups. The birds received organic Zn at the rate of 50 mg/kg (OZ-50) and 60 mg/kg (OZ-60) or inorganic Zn at the rate of 50 mg/kg (IZ-50) and 60 mg/kg (IZ-60) for an experimental period of 30 days. Significantly (P < 0.05) higher feed consumption, body weight, feed conversion ratio, and production efficiency factor (PEF) were recorded in OZ-50. Similarly, antibody titer against infectious bronchitis (IB) and PON1 activity was higher (P < 0.05) in OZ-50 compared with the control group. In addition, significantly (P < 0.05) higher villus dimensions and goblet cell count were recorded for the group OZ-50 compared with other treatments. It was concluded that the organic form of Zn was superior in improving the growth, histological features of intestines, humoral response, and PON1 activity in broiler.


Subject(s)
Chickens/growth & development , Chickens/metabolism , Immunity, Innate/drug effects , Intestines/anatomy & histology , Zinc Compounds/metabolism , Zinc/metabolism , Animal Feed/analysis , Animals , Aryldialkylphosphatase/metabolism , Avian Proteins/metabolism , Diet/veterinary , Dietary Supplements/analysis , Dose-Response Relationship, Drug , Intestines/drug effects , Zinc/administration & dosage , Zinc Compounds/administration & dosage
19.
Tohoku J Exp Med ; 251(3): 175-181, 2020 07.
Article in English | MEDLINE | ID: covidwho-635225

ABSTRACT

The novel coronavirus disease 2019 (COVID-19) is now officially declared as a pandemic by the World Health Organization (WHO), and most parts of the world are taking drastic measures to restrict human movements to contain the infection. Millions around the world are wondering, if there is anything that could be done, other than maintaining high personal hygiene, and be vigilant of the symptoms, to reduce the spread of the disease and chances of getting infected, or at least to lessen the burden of the disease, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The National and International health agencies, including the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the WHO have provided clear guidelines for both preventive and treatment suggestions. In this article, I will briefly discuss, why keeping adequate zinc balance might enhance the host response and be protective of viral infections.


Subject(s)
Betacoronavirus , Coronavirus Infections/prevention & control , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Zinc/physiology , Adjuvants, Immunologic/pharmacology , Adjuvants, Immunologic/therapeutic use , Age Factors , Animals , Antiviral Agents/pharmacology , Antiviral Agents/therapeutic use , Betacoronavirus/drug effects , Betacoronavirus/physiology , COVID-19 , Coronavirus Infections/drug therapy , Coronavirus Infections/immunology , Dietary Supplements , Disease Resistance/drug effects , Dose-Response Relationship, Drug , Humans , Immune System/drug effects , Micronutrients/physiology , Pneumonia, Viral/drug therapy , Pneumonia, Viral/immunology , SARS-CoV-2 , Virus Replication/drug effects , Zinc/administration & dosage , Zinc/deficiency , Zinc/pharmacology
20.
Clin Nutr ESPEN ; 38: 65-66, 2020 08.
Article in English | MEDLINE | ID: covidwho-625686

ABSTRACT

BACKGROUND & AIMS: The COVID-19 infection can lead to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), mainly affecting patients aged 60 and older. Preliminary data suggest that the nutritional status can change the course of the infection, and on the matter, zinc is crucial for growth, development, and the maintenance of immune function. In the absence of treatment for this virus, there is an urgent need to find alternative methods that can contribute to control of disease. The aim of this paper is to establish the relation between zinc and COVID-19. METHODS AND RESULTS: From the prior scientific knowledge, we have performed a review of the literature and examine the role of zinc in immune function in the infection by COVID-19. Our findings are that the zinc as an anti-inflammatory agent may help to optimize immune function and reduce the risk of infection. CONCLUSIONS: Zinc supplementation can be a useful strategy to reduce the global burden of infection in the elderly, there is a need the increased reporting to improve our understanding of COVID-19 and the care of affected patients.


Subject(s)
Betacoronavirus , Coronavirus Infections/drug therapy , Immunity/drug effects , Immunologic Factors/administration & dosage , Pneumonia, Viral/drug therapy , Trace Elements/administration & dosage , Zinc/administration & dosage , Aged , COVID-19 , Coronavirus Infections/immunology , Female , Humans , Immunologic Factors/immunology , Male , Middle Aged , Pandemics , Pneumonia, Viral/immunology , SARS-CoV-2 , Trace Elements/immunology , Zinc/immunology
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