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Investigation of the Efficacy of CARDIO Softgels PLUS Best-standard-of-care in the Recovery of Patients With COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04465513
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 6, 2021
Sponsor:
Collaborator:
KGK Science Inc.
Information provided by (Responsible Party):
Hofseth Biocare ASA

Brief Summary:
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 objective of this study is to investigate the safety and efficacy of CARDIO supplementation in the recovery of those with COVID-19 infection following the guidance from public health by reducing the need for mechanical respiratory support, alleviating respiratory symptoms and reducing mortality.

Condition or disease Intervention/treatment Phase
COVID Covid-19 Dietary Supplement: Best Standard of Care + CARDIO Dietary Supplement: Best Standard of Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Parallel Study to Investigate the Efficacy of CARDIO Softgels PLUS Best-standard-of-care in the Recovery of Patients With COVID-19 Who Are Hospitalized as Well as Patients Following the Guidance From Public Health
Actual Study Start Date : August 31, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Arm Intervention/treatment
Active Comparator: Best Standard of Care + CARDIO
Combination of CARDIO and Best Standard of Care
Dietary Supplement: Best Standard of Care + CARDIO
Combination of dietary supplement with clinical care

Placebo Comparator: Best Standard of Care
Placebo and Best Standard of Care
Dietary Supplement: Best Standard of Care
Combination of placebo with clinical care




Primary Outcome Measures :
  1. Proportion of patients requiring mechanical ventilator until end of study (Day 28) [ Time Frame: 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


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: Day 10, Day 14, Day 28, or Day of discharge ]
    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

  2. Clinical status [ Time Frame: Day 10, Day 14, Day 28, or Day of discharge ]
    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

  3. Time to clinical recovery [ Time Frame: Day 28 or Day of discharge ]
    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

  4. Time to improvement in oxygenation for at least 48 hours [ Time Frame: Day 28 or Day of discharge ]
    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

  5. Quality of life (QoL) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 ]
    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.

  6. All-cause mortality [ Time Frame: Day 28 ]
    Death due to COVID-19 and other reasons

  7. Duration of mechanical ventilator use until end-of-study (Day 28) [ Time Frame: Day 28 ]
    The difference between BSC plus CARDIO vs. BSC alone on duration of mechanical ventilator use until end-of-study

  8. Oxygenation requirements assessed by oxygen saturation rates based on number of oxygenation free days during hospital stay [ Time Frame: During hospital stay, on day of discharge if prior to Day 28, and on Day 28 ]
    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

  9. Oxygenation requirements assessed by oxygen saturation rates based on incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices [ Time Frame: During hospital stay, on day of discharge if prior to Day 28, and on Day 28 ]
    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

  10. Oxygenation requirements assessed by oxygen saturation rates based on duration of new oxygen use, non-invasive ventilation or high flow oxygen devices [ Time Frame: During hospital stay, on day of discharge if prior to Day 28, and on Day 28 ]
    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

  11. Serial chest CT or X-ray findings [ Time Frame: Day 10 and Day 28 or Day of discharge ]
    Serial chest CT or X-ray findings at Day 10, Day 28 or day of discharge

  12. The number of days from hospital admission to hospital discharge [ Time Frame: Up to Day 28 ]
    The difference between BSC plus CARDIO vs. BSC alone on the number of days from hospital admission to hospital discharge

  13. The total number of days on ventilator at Day 28 or day of discharge [ Time Frame: 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

  14. The number of days in intensive care unit (ICU) at Day 28 or day of discharge [ Time Frame: 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

  15. Temperature measurements after discharge and to end of study (Day 28) [ Time Frame: Day 28 and after discharge ]
    The difference between BSC plus CARDIO vs. BSC alone on body temperature measurements after discharge and to end of study (Day 28)

  16. Oxygen saturation measurements after discharge and to end of study (Day 28) [ Time Frame: Day 28 and after discharge ]
    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.

  17. COVID-19 QoL measurements after discharge and to end of study (Day 28) [ Time Frame: Day 28 and after discharge ]
    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.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: Day 0 and up to day 28 ]
    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

  2. Blood pressure [ Time Frame: Day 0 and up to day 28 ]
    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

  3. Heart rate [ Time Frame: Day 0 and up to day 28 ]
    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

  4. Abnormality in laboratory tests [ Time Frame: Day 28 or Day of discharge ]
    Frequency of clinically significant laboratory abnormalities at Day 28 or day of discharge

  5. Body mass Index (BMI) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  6. Complete blood count (CBC) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  7. Aspartate transaminase (AST) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  8. Alanine transaminase (ALT) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  9. Alkaline phosphatase (ALP) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  10. Bilirubin [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  11. Sodium ion [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  12. Potassium ion [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  13. Chloride ion [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  14. Creatinine [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  15. eGFR [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  16. HbA1c [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  17. Glucose [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    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.

  18. C-Reactive protein (CRP) [ Time Frame: Day 0, Day 10, Day 14, and Day 28 from baseline ]
    Changes in CRP from screening



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with signs and symptoms corresponding to COVID-19 viral infection and:
  2. Admitted to hospital and who have been initiated with BSC treatment with mild to moderate disease as defined by the National Institutes of Health (NIH) Treatment Guidelines
  3. Confirmation of COVID-19 infection This will be assessed by secondary laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) or comparable methodology used by the hospital from any diagnostic sampling - source for analysis and recovery
  4. Males and females between 18 and 75 years of age, inclusive
  5. Female patient is not of child-bearing potential, defined as females who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening

    Or,

    Females of child-bearing potential must have a negative urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:

    • Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
    • Double-barrier method
    • Intrauterine devices
    • Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
    • Vasectomy of partner at least 6 months prior to screening
  6. Willingness to complete assessments, questionnaires and records associated with the study
  7. Provided voluntary, written, informed consent to participate in the study

Exclusion Criteria:

  1. Women who are pregnant, breast feeding, or planning to become pregnant during the study
  2. Inability to take medications orally
  3. Individuals with a known fish allergy or hypersensitivity reaction
  4. Individuals with uncontrolled hypotension (systolic blood pressure < 90 mmHg) or need for vasopressor/inotropic medication
  5. Individuals with renal impairment This will be assessed by increase of creatinine by 50% from baseline, glomerular filtration rate reduction by >25% from baseline or urine output of <0.5 ml/kg for 6 hours)
  6. Individuals with gastrointestinal symptoms that require hospitalization (e.g. severe nausea, vomiting, diarrhea or/and abdominal pain) Any other condition, that, in the opinion of the QI, may adversely affect the patient's ability to complete the study or its measures or pose significant risk to the patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04465513


Contacts
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Contact: Malkanthi Evans, PhD 5194389374 ext 239 mevans@kgkscience.com
Contact: Andrew Charrette, MSc 5194389374 ext 232 acharrette@kgkscience.com

Locations
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Brazil
Hospital Universitario Cassiano Antonio de Morais Not yet recruiting
Vitória, Espírito Santo, Brazil, 29041-295
Contact: Tania Reuter       tania.reuter@ebserh.gov.br   
- Instituto de Pesquisa Clínica de Campinas Not yet recruiting
Campinas, Brazil, 13060-080
Contact: José F Saraiva       saraiva@ipecc.com.br   
Instituto Santa Marta de Ensino e Pesquisa Not yet recruiting
Taguatinga, Brazil, 72025-072
Contact: Isaac A Silva       isaacazevedosilva@gmail.com   
Canada, Ontario
KGK Science Inc. Recruiting
London, Ontario, Canada, N6A 5R8
Contact: Mal Evans, PhD    5194389374    mevans@kgkscience.com   
Hungary
Markhot Ferenc Oktatókórház és Rendelőintézet, Eger Not yet recruiting
Eger, Hungary, 3300
Contact: Péter Ilonczai, MD, PhD       ilonczaipeter@gmail.com   
Albert Schweitzer Kórház-Rendelőintézet, Hatvan Not yet recruiting
Hatvan, Hungary, 3000
Contact: Ákos Sarnyai, MD         
Contact       akos.sarnyai.md@gmail.com   
Mexico
The American British Cowdray Medical Center I.A.P. Not yet recruiting
Ciudad de México, Mexico, 01120
Contact: Benjamín V Acosta       benjamin_valente@hotmail.com   
Serbia
General Hospital Paracin Not yet recruiting
Paracin, Serbia, 35250
Contact: Mirjana Petrovic, MD       mirjana.petrovic24@gmail.com   
Sponsors and Collaborators
Hofseth Biocare ASA
KGK Science Inc.
Investigators
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Principal Investigator: David Crowley, MD KGK Science Inc.
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Responsible Party: Hofseth Biocare ASA
ClinicalTrials.gov Identifier: NCT04465513    
Other Study ID Numbers: 20CCHH
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 6, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No