Covid 19 Research using Clinical Trials (Home Page)
Report for D011657: Pulmonary Eosinophilia NIH
(Synonyms: Pulmonary Eosinophil, Pulmonary Eosinophilia)
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
There is one clinical trial.
Clinical Trials
1 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
Corona virus disease 2019 (COVID-19) is caused by SARS-CoV-2, a plus-sense single-stranded RNA virus. After an incubation period, which typically lasts for 5-6 days, COVID-19 patients present with a mild illness that lasts for a few days. Common symptoms are reminiscent of the flu, and include fever, dry cough and dyspnea. A large percentage of patients resolve the infection whereas others progress onto adult respiratory distress syndrome (ARDS) which impedes gas exchange between the alveolar space and the bloodstream and creates the need for assisted respiration.The objectives of this randomized, open-label, parallel study is to investigate the safety and efficacy of CARDIO plus best standard-of-care in reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality in hospitalized former smoker and steroid-resistant asthma patients with COVID-19 infection.
NCT04465513 Asthma; Eosinophilic COVID Covid-19 Dietary Supplement: Best Standard of Care + CARDIO Dietary Supplement: Best Standard of Care MeSH:Asthma Pulmonary Eosinophilia
HPO:Asthma
Primary Outcomes
Description: Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (oxygen saturation rates) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline
Description: Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (supplemental Oxygen) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline
Description: Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (ventilator support) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline
Secondary Outcomes
Description: 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
Measure: Clinical improvement Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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
Measure: Clinical status Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.
Measure: Serial chest CT or X-ray findings Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours
Measure: Time to clinical recovery Time: Day 28 from baseline or day of discharge
Description: increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2
Measure: Time to improvement in oxygenation for at least 48 hours Time: Day 28 from baseline or day of discharge
Description: The number of days from hospital admission to hospital discharge
Measure: Hospitalization period Time: Day 28 from baseline or day of discharge
Description: The total number of days on ventilator
Measure: Amount of time on Ventilator Time: Day 28 from baseline or day of discharge
Description: number of days in intensive care unit (ICU)
Measure: Intensive Care stay Time: Day 28 from baseline or day of discharge
Description: 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
Measure: Quality of life (QoL) Time: Day1, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: Death due to COVID-19 and other reasons
Measure: All-cause mortality Time: Day 28 from baseline or day of discharge
Description: Body temperatures
Measure: Temperature measurements Time: Day 28 from baseline or day of discharge
Description: measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.
Measure: Oxygen saturation measurements Time: Day 28 from baseline or day of discharge
Description: 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
Measure: COVID-19 QoL measurements Time: Day 28 from baseline or day of discharge
Other Outcomes
Description: Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)
Measure: Adverse Events Time: During 15 days of supplementation or until day of discharge and during home follow up
Description: systolic and diastolic
Measure: Blood pressure Time: From baseline to 28 days thereafter
Description: Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using
Measure: Heart rate Time: Everyday From baseline to 28 days thereafter
Description: Frequency of clinically significant laboratory abnormalities.
Measure: Abnormality in laboratory tests Time: Day 28 from baseline or day of discharge
Description: 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.
Measure: Body mass Index (BMI) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Complete blood count (CBC) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Aspartate transaminase (AST) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Alanine transaminase (ALT) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Alkaline phosphatase (ALP) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Bilirubin Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Sodium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Potassium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Chloride ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: 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.
Measure: Creatinine Time: Daily From baseline to 28 days thereafter
Description: 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.
Measure: eGFR Time: Daily From baseline to 28 days thereafter
Description: 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.
Measure: HbA1c Time: Daily From baseline to 28 days thereafter
Description: 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.
Measure: Glucose Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge
Description: CRP value only taken at baseline for every participant
Measure: C-Reactive protein (CRP) Time: Baseline only
HPO Nodes
Primary Outcomes
Description: Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (oxygen saturation rates) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (supplemental Oxygen) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineDescription: Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)
Measure: Oxygenation requirements during hospital stay (ventilator support) Time: On day of discharge if earlier than 28 days from baseline, then 28 days from baselineSecondary Outcomes
Description: 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
Measure: Clinical improvement Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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
Measure: Clinical status Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.
Measure: Serial chest CT or X-ray findings Time: Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours
Measure: Time to clinical recovery Time: Day 28 from baseline or day of dischargeDescription: increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2
Measure: Time to improvement in oxygenation for at least 48 hours Time: Day 28 from baseline or day of dischargeDescription: The number of days from hospital admission to hospital discharge
Measure: Hospitalization period Time: Day 28 from baseline or day of dischargeDescription: The total number of days on ventilator
Measure: Amount of time on Ventilator Time: Day 28 from baseline or day of dischargeDescription: number of days in intensive care unit (ICU)
Measure: Intensive Care stay Time: Day 28 from baseline or day of dischargeDescription: 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
Measure: Quality of life (QoL) Time: Day1, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: Death due to COVID-19 and other reasons
Measure: All-cause mortality Time: Day 28 from baseline or day of dischargeDescription: Body temperatures
Measure: Temperature measurements Time: Day 28 from baseline or day of dischargeDescription: measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.
Measure: Oxygen saturation measurements Time: Day 28 from baseline or day of dischargeDescription: 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
Measure: COVID-19 QoL measurements Time: Day 28 from baseline or day of dischargeOther Outcomes
Description: Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)
Measure: Adverse Events Time: During 15 days of supplementation or until day of discharge and during home follow upDescription: systolic and diastolic
Measure: Blood pressure Time: From baseline to 28 days thereafterDescription: Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using
Measure: Heart rate Time: Everyday From baseline to 28 days thereafterDescription: Frequency of clinically significant laboratory abnormalities.
Measure: Abnormality in laboratory tests Time: Day 28 from baseline or day of dischargeDescription: 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.
Measure: Body mass Index (BMI) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Complete blood count (CBC) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Aspartate transaminase (AST) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Alanine transaminase (ALT) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Alkaline phosphatase (ALP) Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Bilirubin Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Sodium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Potassium ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Chloride ion Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: 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.
Measure: Creatinine Time: Daily From baseline to 28 days thereafterDescription: 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.
Measure: eGFR Time: Daily From baseline to 28 days thereafterDescription: 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.
Measure: HbA1c Time: Daily From baseline to 28 days thereafterDescription: 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.
Measure: Glucose Time: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of dischargeDescription: CRP value only taken at baseline for every participant
Measure: C-Reactive protein (CRP) Time: Baseline only