Covid 19 Research using Clinical Trials (Home Page)
HP:0002099: AsthmaHPO
Developed by Shray Alag
Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (16)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug2481 | Tezepelumab Wiki | 0.50 |
| drug232 | Asthma reliever therapies Wiki | 0.50 |
| drug517 | Canakinumab Injection 600mg Wiki | 0.50 |
| drug1519 | Montelukast Oral Granules Wiki | 0.50 |
| drug334 | Best Standard of Care + CARDIO Wiki | 0.50 |
| drug516 | Canakinumab Injection 300mg Wiki | 0.50 |
| drug796 | Dupilumab (SAR231893/REGN668) Wiki | 0.50 |
| drug519 | Cannabidiol Wiki | 0.50 |
| drug333 | Best Standard of Care Wiki | 0.50 |
| drug521 | Caption AI Wiki | 0.50 |
| drug231 | Asthma controller therapies (incl. prednisone/prednisolone) Wiki | 0.50 |
| drug520 | Capillary and salivary sampling Wiki | 0.50 |
| drug1738 | PLACEBO Wiki | 0.35 |
| drug2441 | Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling. Wiki | 0.35 |
| drug1860 | Placebos Wiki | 0.12 |
| drug1822 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (11)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D001249 | Asthma NIH | 1.00 |
| D001982 | Bronchial Diseases NIH | 0.50 |
| D006969 | Hypersensitivity, Immediate NIH | 0.50 |
| D012130 | Respiratory Hypersensitivity NIH | 0.50 |
| D011657 | Pulmonary Eosinophilia NIH | 0.50 |
| D006967 | Hypersensitivity, NIH | 0.29 |
| D007154 | Immune System Diseases NIH | 0.20 |
| D008173 | Lung Diseases, Obstructive NIH | 0.17 |
| D008171 | Lung Diseases, NIH | 0.13 |
| D012140 | Respiratory Tract Diseases NIH | 0.12 |
| D007249 | Inflammation NIH | 0.10 |
Correlated HPO Terms (3)
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012393 | Allergy HPO | 0.29 |
| HP:0006536 | Pulmonary obstruction HPO | 0.17 |
| HP:0002088 | Abnormal lung morphology HPO | 0.13 |
There are 4 clinical trials
Clinical Trials
1 Pragmatic RCT of High-dose Oral Montelukast for Moderate and Severe Pediatric Acute Asthma Exacerbations
Objective: To determine the extent to which high-dose (30mg) oral montelukast, added to standard treatment in children with moderate and severe acute exacerbations improves outcomes. Central Hypothesis: High-dose oral montelukast, added to standard treatment in children aged 5 to 17 years with moderate and severe acute asthma exacerbations, rapidly improves lung function, clinical severity, hospitalization rate and 72-hour symptom burden. Secondary Hypotheses: 1. There are greater effects of high-dose oral montelukast on lung function and on the secondary outcomes in the presence of respiratory viral detection or leukotriene-mediated inflammation; and 2. There is an interaction between viral detection and urinary leukotriene 4 level with treatment-response. Design: A two-arm, parallel randomized controlled trial of high-dose oral montelukast versus identical placebo, as add-on to standard treatment of systemic corticosteroid (SCS) and inhaled short-acting Beta-2-agonist (SABA), in children aged 5 to 17 years with moderate and severe acute asthma exacerbations. Intervention: High-dose oral montelukast added to standard treatment as one treatment-allocation arm, in comparison with standard treatment as the 2nd treatment-allocation arm. Primary and Important Secondary Endpoints: For the Primary Aim, the primary outcome measure to be compared between arms will be change of %-predicted airway resistance by impulse oscillometry (IOS) at 5Hz (%R5) at 2 hours after treatment initiation. Secondary outcomes will include improvement of %-predicted FEV1 (%FEV1), clinical severity measured using the validated Acute Asthma Intensity Research Score (AAIRS), hospitalization rate, and 72 hour symptom burden using the Pediatric Asthma Caregiver Diary (PACD). For the Secondary Aim, the investigators will determine (1) The effects of high-dose oral montelukast on lung function and on our secondary outcomes in the presence of nasal viruses and of greater leukotriene-mediated inflammation; and (2) The degree of interaction between viral detection and urinary leukotriene E4 (LTE4) level with treatment-response. Laboratory evaluations: The primary outcome (change of %R5) and select secondary outcomes (%FEV1, AAIRS, LTE4) will be measured before and again at 2 hours after treatment initiation. The other secondary outcomes will be measured at the time of hospitalization decision-making by the clinical team (hospitalization rate) or at 72-hours after treatment initiation (PACD).
NCT03277170 Asthma; Status Asthma in Children Asthma Acute Asthma Attack Acute Asthma Exacerbation Drug: Montelukast Oral Granules MeSH:Asthma
HPO:Asthma
Primary Outcomes
Description: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometrypost montelukast or control administration
Measure: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry Time: Before and 2-hours after treatment with montelukast or placebo
Secondary Outcomes
Description: Change of percent-predicted forced expiratory volume in 1-second (FEV1)
Measure: Change of percent-predicted forced expiratory volume in 1-second (FEV1) Time: Before and 2-hours after treatment with montelukast or placebo
Description: Change of the Acute Asthma Intensity Research Score (AAIRS)
Measure: Change of the Acute Asthma Intensity Research Score (AAIRS) Time: Before and 2-hours after treatment with montelukast or placebo
Description: Leukotriene E4 (LTE4)
Measure: Leukotriene E4 (LTE4) Time: Before treatment with montelukast or placebo
Description: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)
Measure: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD) Time: Before and at 72-hours after treatment with montelukast or placebo
Description: Hospitalization rate
Measure: Hospitalization rate Time: 8-hours after treatment with montelukast or placebo
2 One Year Study to Evaluate the Long-term Safety and Tolerability of Dupilumab in Pediatric Patients With Asthma Who Participated in a Previous Dupilumab Asthma Clinical Study
Primary Outcomes
Description: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometrypost montelukast or control administration
Measure: Change of percent-predicted airway resistance at 5Hz (%R5) by impulse oscillometry Time: Before and 2-hours after treatment with montelukast or placeboSecondary Outcomes
Description: Change of percent-predicted forced expiratory volume in 1-second (FEV1)
Measure: Change of percent-predicted forced expiratory volume in 1-second (FEV1) Time: Before and 2-hours after treatment with montelukast or placeboDescription: Change of the Acute Asthma Intensity Research Score (AAIRS)
Measure: Change of the Acute Asthma Intensity Research Score (AAIRS) Time: Before and 2-hours after treatment with montelukast or placeboDescription: Leukotriene E4 (LTE4)
Measure: Leukotriene E4 (LTE4) Time: Before treatment with montelukast or placeboDescription: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD)
Measure: 72-hours symptom burden measured using the pediatric asthma caregiver diary (PACD) Time: Before and at 72-hours after treatment with montelukast or placeboDescription: Hospitalization rate
Measure: Hospitalization rate Time: 8-hours after treatment with montelukast or placeboPrimary Objective: To evaluate the long-term safety and tolerability of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. Secondary Objectives: - To evaluate the long-term efficacy of dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study. - To evaluate dupilumab in pediatric patients with asthma who participated in a previous dupilumab asthma clinical study with regard to: - Systemic exposure. - Anti-drug antibodies (ADAs). - Biomarkers.
NCT03560466 Asthma Drug: Dupilumab (SAR231893/REGN668) Drug: Asthma controller therapies (incl. prednisone/prednisolone) Drug: Asthma reliever therapies MeSH:Asthma
HPO:Asthma
Primary Outcomes
Description: The number (n) and percentage (%) of patients experiencing any TEAE
Measure: Treatment-emergent adverse events (TEAEs) Time: From Day 1 up to Week 64
Secondary Outcomes
Description: Annualized rate of severe asthma exacerbation events, during the treatment period
Measure: Severe asthma exacerbation events Time: From Day 1 up to Week 52
Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
Measure: Change in % predicted FEV1 Time: From Day 1 up to Week 64
Description: Change in absolute FEV1 - Clinically significant changes from baseline
Measure: Change in absolute FEV1 Time: From Day 1 up to Week 64
Description: Change in forced vital capacity (FVC)
Measure: Change in FVC Time: From Day 1 up to Week 64
Description: Change in forced expiratory flow (FEF) 25-75%
Measure: Change in FEF Time: From Day 1 up to Week 64
Description: Serum dupilumab concentrations - Changes from first dupilumab injection
Measure: Assessment of dupilumab concentration Time: From Day 1 up to Week 64
Description: Titers of Anti-dupilumab antibodies
Measure: Assessment of immunogenicity Time: From Day 1 up to Week 64
Description: Blood: Eosinophil count
Measure: Assessment of blood Eosinophil count Time: From Day 1 up to Week 64
Description: Serum: total IgE
Measure: Assessment of total immunoglobulin E (IgE) Time: From Day 1 up to Week 64
3 A Phase 2, Randomized, Double-blind, Parallel Group, Placebo Controlled Study to Evaluate the Effect of Tezepelumab on Airway Inflammation in Adults With Inadequately Controlled Asthma on Inhaled Corticosteroids and at Least One Additional Asthma Controller (CASCADE)
Primary Outcomes
Description: The number (n) and percentage (%) of patients experiencing any TEAE
Measure: Treatment-emergent adverse events (TEAEs) Time: From Day 1 up to Week 64Secondary Outcomes
Description: Annualized rate of severe asthma exacerbation events, during the treatment period
Measure: Severe asthma exacerbation events Time: From Day 1 up to Week 52Description: Change in percentage (%) predicted forced expiratory volume in 1 second (FEV1) - Clinically significant changes from baseline
Measure: Change in % predicted FEV1 Time: From Day 1 up to Week 64Description: Change in absolute FEV1 - Clinically significant changes from baseline
Measure: Change in absolute FEV1 Time: From Day 1 up to Week 64Description: Change in forced vital capacity (FVC)
Measure: Change in FVC Time: From Day 1 up to Week 64Description: Change in forced expiratory flow (FEF) 25-75%
Measure: Change in FEF Time: From Day 1 up to Week 64Description: Serum dupilumab concentrations - Changes from first dupilumab injection
Measure: Assessment of dupilumab concentration Time: From Day 1 up to Week 64Description: Titers of Anti-dupilumab antibodies
Measure: Assessment of immunogenicity Time: From Day 1 up to Week 64Description: Blood: Eosinophil count
Measure: Assessment of blood Eosinophil count Time: From Day 1 up to Week 64Description: Serum: total IgE
Measure: Assessment of total immunoglobulin E (IgE) Time: From Day 1 up to Week 64A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in adults with inadequately controlled asthma.
NCT03688074 Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Biological: Tezepelumab Other: Placebo MeSH:Asthma Lung Diseases Lung Diseases, Obstructive Bronchial Diseases Respiratory Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Inflammation Respiratory Tract Diseases Immune System Diseases
HPO:Abnormal lung morphology Allergy Asthma Pulmonary obstruction
Primary Outcomes
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Secondary Outcomes
Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.
4 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
Primary Outcomes
Description: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies.
Measure: The change from baseline in number of airway submucosal inflammatory cells/mm2 of bronchoscopic biopsies. Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Secondary Outcomes
Description: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in reticular basement membrane (RBM) thickness from baseline, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in % airway epithelial integrity from baseline determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.Description: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies
Measure: The change in number of airway submucosal inflammatory cells per mm2 from baseline, across the spectrum of T2 status, determined by microscopic evaluation of bronchoscopic biopsies Time: Baseline, End of Treatment (EoT). The EoT will be performed at Week 28 for the majority of subjects but may be performed at later timepoints for some subjects (Week 32, etc.) due to up to 6 additional doses added during the Covid-19 pandemic.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
HP:0002099: Asthma
Genes 152
RSPH1 DOCK8 NKX2-1 CBL TNF SPAG1 FOXJ1 MCIDAS LIG4 AFF4 GAS2L2 LMX1B SCN4A DNAH1 TET2 CCDC151 ARL6 DNAL1 SCGB3A2 ALMS1 FOXH1 CCL11 CCDC28B ADRB2 COMT CDON SHH CFAP221 SDHD PEX5 GRHL2 DNAAF1 GP1BA RPGR RSPH9 STK36 JMJD1C PTGER2 DNAH9 TBCK COX4I2 OFD1 LRBA RSPH4A DNAH5 HIRA IL4R RREB1 STXBP1 NME8 GAS8 COL5A1 TTC12 NEK9 NSUN2 CFTR MUC7 IDS PGM3 GLI2 CCDC65 DOCK8 CFAP298 RUNX1 GTF2H5 TBX1 PLCG2 NOD2 CFAP300 TBX21 PLA2G7 ALOX5 ZIC2 DNAI1 PTCH1 MTOR DNAJB13 TRAIP SPEF2 SRSF2 CCDC40 ALMS1 ZMYND10 BBS1 COL1A1 SIX3 GAS1 SIK3 IL13 NODAL CCDC39 ARMC4 TALDO1 GP1BB TTC25 DNAAF2 ELOVL4 DNAI2 ARVCF DDX41 NKX2-1 TBX1 NFKB2 DRC1 FCGR2A DISP1 NEK10 USP7 TGIF1 SPINK5 RSPH3 LRRC6 CARMIL2 HLA-G LIFR DNAAF5 CCNO CDSN COL5A2 TGFB1 GP9 FLG PLA2G7 HYDIN DNAAF6 SEC24C CASP8 SUFU CCDC114 CCDC103 ASXL1 LRRC56 PEPD SPINK5 FGF8 DNAAF4 HNMT BCL11B CCDC151 ERCC2 DLL1 MS4A2 GP1BB DNAAF3 CARD11 UFD1 RIC1 ADA TDGF1 PGM3 FGFR1 DNAH11
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