Combination of CARDIO and Best Standard of Care

Asthma; Eosinophilic

COVID

Covid-19

Combination of dietary supplement with clinical care

Best Standard of Care + CARDIO

Combination of placebo with clinical care

Best Standard of Care

KGK Science Inc.

Investigation of Safety and Efficacy of CARDIO Softgels in Former Smokers and Asthma Patients With COVID-19 Infection

Randomized, Open-label, Parallel Study to Investigate Safety and Efficacy of CARDIO Softgels Plus Best Standard-of-care vs. Best Standard-of-care Alone on a Former Smoker and/or Steroid-resistant Asthma Population With COVID-19 Infection

Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

Assessed by the National Early Warning Score (NEWS) which is a standardized tool that assesses disease severity and monitoring of patients in hospital. An aggregate score of respiration rate, oxygen saturation, systolic blood pressure, pulse rate, level of consciousness and temperature and the score is increased if supplemental oxygen is required. Each parameter is based on a scale of 0 - 3. 0=good, 3=poor

Assessed by the WHO Ordinal Scale for Clinical Improvement which examines changes in clinical status and/or survival specific to COVID-19. This 8-point scale measures illness severity over time. 0 = no infection and 8 = dead

Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.

This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours

increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2

The number of days from hospital admission to hospital discharge

number of days in intensive care unit (ICU)

assessed by the COVID-19 QoL questionnaire which asks questions about incident of different parameters related to deteriorating. It is on a scale of 1-5. 1=completely disagree, 5 = completely agree

measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.

Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)

Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using

Frequency of clinically significant laboratory abnormalities.

BMI values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

CBC values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

AST values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

ALT values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

ALP values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Bilirubin values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Sodium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Potassium ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Chloride ion values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

Creatinine values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

eGFR values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

HbA1c values for the CARDIO softgel + BSC group will be compared with those of the BSC group using statistical analysis to determine significant difference between the two groups. Samples are taken in the days stated below.

CRP value only taken at baseline for every participant

Hofseth Biocare ASA

Severe Asthma

Obesity

withdrawing a part of the stomach and may or may not be combined with bowel deviation

Bariatric

Clinical, Inflammatory and Functional Evaluation of a Population of Severe and Obese Asthmatics: Follow up

Brazilian Severe Asthma Cohort Follow up: Clinical, Inflammatory and Functional Evaluation of a Population of Severe Asthmatics Based in Possible Phenotypes and Pathophysiologic Study of Obesity Association

To assess the rate of loss of lung function in patients with severe asthma, who remain in regular follow - up and under adequate therapy since 2006.

To evaluate the functional airways characteristics of obese asthmatic patients, compared to non-obese asthmatics, before and after bariatric surgery

To compare the degree of bronchial thickening, through chest tomography

Mortality and Hospitalizations per patient/year

To compare the heterogeneity amount of small airways

Rafael Stelmach

Assistant Professor - Pulmonary Division - Heart Institute (InCor)

University of Sao Paulo General Hospital

AstraZeneca

flecainide x 6 months, then crossover to sotalol x 6 months

sotalol x 6 months, then crossover to flecainide x 6 months

Atrial Fibrillation

flecainide up to 150mg twice daily for the control of atrial fibrillation

Flecainide

sotalol up to 120mg twice daily for the control of atrial fibrillation

Sotalol

Jesse Brown VA Medical Center

Rush University Medical Center

University of Illinois at Chicago

Advocate Christ Medical Center

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

A Prospective, Multi-Center, Randomized, Open Label Trial to Determine if a Common Atrial Fibrillation Risk Locus Modulates Differential Response to Antiarrhythmic Drugs

Subjects will be monitored with the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) system to assess AF burden. The device will be programmed to optimize the memory for storing AF episode..

Quality of life assessment: Patients will be asked to fill out the AFEQT quality of life questionnaire baseline (study randomization), two, four, six, eight, ten, and 12 months (completion of the study). The questionnaire at the end of the 6rd month will be administered just prior to stopping the first study drug. The validated questionnaire is comprised of 20 questions about AF symptoms with answers given on a Likert scale. The questionnaire will be provided to the patients in paper format either in person or by mail, as applicable. A follow-up phone call will be made to each patient to ensure that the questionnaire is completed and returned.

eosinophilia/obesidade

Investigation of Safety and Efficacy of CARDIO Softgels in Former Smokers and Asthma Patients With COVID-19 Infection

Clinical, Inflammatory and Functional Evaluation of a Population of Severe and Obese Asthmatics: Follow up

Pharmacogenetic Study of Antiarrhythmic Drugs for Atrial Fibrillation

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