Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Other |
Adverse Events |
Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs) during the 28 days of supplementation or until day of discharge and during home follow up |
Day 0 and up to day 28 |
|
Other |
Blood pressure |
Systolic and diastolic blood pressure values for the CARDIO softgel + BSC group will be compared with those of the BSC group during the 28-day supplementation period or until day of discharge and during home follow up |
Day 0 and up to day 28 |
|
Other |
Heart rate |
Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group during the 28-day supplementation period or until day of discharge and during home follow up |
Day 0 and up to day 28 |
|
Other |
Abnormality in laboratory tests |
Frequency of clinically significant laboratory abnormalities at Day 28 or day of discharge |
Day 28 or Day of discharge |
|
Other |
Body mass Index (BMI) |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Complete blood count (CBC) |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Aspartate transaminase (AST) |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Alanine transaminase (ALT) |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Alkaline phosphatase (ALP) |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Bilirubin |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Sodium ion |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Potassium ion |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Chloride ion |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Creatinine |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
eGFR |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
HbA1c |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
Glucose |
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. |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Other |
C-Reactive protein (CRP) |
Changes in CRP from screening |
Day 0, Day 10, Day 14, and Day 28 from baseline |
|
Primary |
Proportion of patients requiring mechanical ventilator until end of study (Day 28) |
Proportion of patients requiring mechanical ventilator until end-of-study, when comparing Best Standard of Care treatment (BSC) plus CARDIO unrefined salmon oil vs. BSC alone |
Day 28 |
|
Secondary |
Clinical improvement |
Clinical improvement assessed by the National Early Warning Score (NEWS) at Day 10, Day 14, Day 28 or day of discharge. 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 |
Day 10, Day 14, Day 28, or Day of discharge |
|
Secondary |
Clinical status |
Clinical status assessed by the WHO Ordinal Scale for Clinical Improvement at Day 10, Day 14, Day 28 or day of discharge. 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 |
Day 10, Day 14, Day 28, or Day of discharge |
|
Secondary |
Time to clinical recovery |
Time to clinical recovery, defined as normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough, sustained for at least 72 hours, at Day 28 or day of discharge |
Day 28 or Day of discharge |
|
Secondary |
Time to improvement in oxygenation for at least 48 hours |
Time to improvement in oxygenation for at least 48 hours, defined by an increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2, at Day 28 or day of discharge |
Day 28 or Day of discharge |
|
Secondary |
Quality of life (QoL) |
Quality of life assessed by the COVID-19 QoL questionnaire at Day 0, Day 10, Day 14, and Day 28. 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. |
Day 0, Day 10, Day 14, and Day 28 |
|
Secondary |
All-cause mortality |
Death due to COVID-19 and other reasons |
Day 28 |
|
Secondary |
Duration of mechanical ventilator use until end-of-study (Day 28) |
The difference between BSC plus CARDIO vs. BSC alone on duration of mechanical ventilator use until end-of-study |
Day 28 |
|
Secondary |
Oxygenation requirements assessed by oxygen saturation rates based on number of oxygenation free days during hospital stay |
Oxygenation requirements during hospital stay, on day of discharge if prior to Day 28 and on Day 28, assessed by oxygen saturation rates based on number of oxygenation free days during hospital stay |
During hospital stay, on day of discharge if prior to Day 28, and on Day 28 |
|
Secondary |
Oxygenation requirements assessed by oxygen saturation rates based on incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices |
Oxygenation requirements during hospital stay, on day of discharge if prior to Day 28 and on Day 28, assessed by oxygen saturation rates based on incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices |
During hospital stay, on day of discharge if prior to Day 28, and on Day 28 |
|
Secondary |
Oxygenation requirements assessed by oxygen saturation rates based on duration of new oxygen use, non-invasive ventilation or high flow oxygen devices |
Oxygenation requirements during hospital stay, on day of discharge if prior to Day 28 and on Day 28, assessed by oxygen saturation rates based on duration of new oxygen use, non-invasive ventilation or high flow oxygen devices |
During hospital stay, on day of discharge if prior to Day 28, and on Day 28 |
|
Secondary |
Serial chest CT or X-ray findings |
Serial chest CT or X-ray findings at Day 10, Day 28 or day of discharge |
Day 10 and Day 28 or Day of discharge |
|
Secondary |
The number of days from hospital admission to hospital discharge |
The difference between BSC plus CARDIO vs. BSC alone on the number of days from hospital admission to hospital discharge |
Up to Day 28 |
|
Secondary |
The total number of days on ventilator at Day 28 or day of discharge |
The difference between BSC plus CARDIO vs. BSC alone on the total number of days on ventilator at Day 28 or day of discharge |
Day 28 or Day of discharge |
|
Secondary |
The number of days in intensive care unit (ICU) at Day 28 or day of discharge |
The difference between BSC plus CARDIO vs. BSC alone on the number of days in intensive care unit (ICU) at Day 28 or day of discharge |
Day 28 or Day of discharge |
|
Secondary |
Temperature measurements after discharge and to end of study (Day 28) |
The difference between BSC plus CARDIO vs. BSC alone on body temperature measurements after discharge and to end of study (Day 28) |
Day 28 and after discharge |
|
Secondary |
Oxygen saturation measurements after discharge and to end of study (Day 28) |
The difference between BSC plus CARDIO vs. BSC alone on oxygen saturation measurements after discharge and to end of study (Day 28). Oxygen saturation saturation measurements recorded using a pulse oximeter. |
Day 28 and after discharge |
|
Secondary |
COVID-19 QoL measurements after discharge and to end of study (Day 28) |
The difference between BSC plus CARDIO vs. BSC alone on COVID-19 QoL measurements after discharge and to end of study (Day 28). Quality of life 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. |
Day 28 and after discharge |
|