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

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 : Not yet recruiting
First Posted : July 10, 2020
Last Update Posted : July 10, 2020
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 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.

Condition or disease Intervention/treatment Phase
Asthma; Eosinophilic 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 : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 31, 2020
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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. Oxygenation requirements during hospital stay (oxygen saturation rates) [ Time Frame: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline ]
    Oxygen saturation rates (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

  2. Oxygenation requirements during hospital stay (supplemental Oxygen) [ Time Frame: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline ]
    Requirement for supplemental oxygen (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)

  3. Oxygenation requirements during hospital stay (ventilator support) [ Time Frame: On day of discharge if earlier than 28 days from baseline, then 28 days from baseline ]
    Requirement for advanced ventilator support (Best Standard of Care treatment (BSC) plus CARDIO vs. BSC alone)


Secondary Outcome Measures :
  1. Clinical improvement [ Time Frame: Day 10, Day 14, from baseline, Day 28 from baseline 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, from baseline, Day 28 from baseline 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. Serial chest CT or X-ray findings [ Time Frame: Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge ]
    Serial chest CT or X-ray findings for the CARDIO softgel + BSC group will be compared with those of the BSC group.

  4. Time to clinical recovery [ Time Frame: Day 28 from baseline or day of discharge ]
    This is defined as sustained normalization of fever, respiratory rate, oxygen saturation, and alleviation of cough for at least 72 hours

  5. Time to improvement in oxygenation for at least 48 hours [ Time Frame: Day 28 from baseline or day of discharge ]
    increase in SpO2/FiO2 of 50 mmHg or greater compared to the nadir SpO2/FiO2

  6. Hospitalization period [ Time Frame: Day 28 from baseline or day of discharge ]
    The number of days from hospital admission to hospital discharge

  7. Amount of time on Ventilator [ Time Frame: Day 28 from baseline or day of discharge ]
    The total number of days on ventilator

  8. Intensive Care stay [ Time Frame: Day 28 from baseline or day of discharge ]
    number of days in intensive care unit (ICU)

  9. Quality of life (QoL) [ Time Frame: Day1, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge ]
    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

  10. All-cause mortality [ Time Frame: Day 28 from baseline or day of discharge ]
    Death due to COVID-19 and other reasons

  11. Temperature measurements [ Time Frame: Day 28 from baseline or day of discharge ]
    Body temperatures

  12. Oxygen saturation measurements [ Time Frame: Day 28 from baseline or day of discharge ]
    measured using a pulse oximetry device, which is a non-invasive method to measure arterial oxygen saturation level.

  13. COVID-19 QoL measurements [ Time Frame: Day 28 from baseline or day of discharge ]
    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: During 15 days of supplementation or until day of discharge and during home follow up ]
    Incidence of pre-emergent and post-emergent adverse events (AEs) and serious adverse events (SAEs)

  2. Blood pressure [ Time Frame: From baseline to 28 days thereafter ]
    systolic and diastolic

  3. Heart rate [ Time Frame: Everyday From baseline to 28 days thereafter ]
    Heart rate values for the CARDIO softgel + BSC group will be compared with those of the BSC group using

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

  5. Body mass Index (BMI) [ Time Frame: Day 0, Day 10, Day 14, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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: Daily From baseline to 28 days thereafter ]
    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: Daily From baseline to 28 days thereafter ]
    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: Daily From baseline to 28 days thereafter ]
    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, from baseline, Day 28 from baseline or day of discharge ]
    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: Baseline only ]
    CRP value only taken at baseline for every participant



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. Former smoker, defined as anyone who has stopped smoking for 3 months prior to enrollment and who had smoked at least 100 cigarettes in their lifetime and/or patients with steroid-resistant asthma
  2. Patients with signs and symptoms corresponding to COVID-19 viral infection admitted to hospital and who have been initiated with BSC treatment
  3. Secondary laboratory confirmation of COVID-19 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. Mild to moderate disease (National Early Warning Score of ≤ 6)
  5. Males and females between 18 and 75 years of age, inclusive
  6. BMI between 18.5 to 34.9 kg/m2, inclusive
  7. Absolute neutrophil count (ANC) ≥ 0.6 ×109 cells/L
  8. 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 baseline 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
  9. Willingness to complete assessments, questionnaires and records associated with the study
  10. 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. Current use of antiretroviral agents
  5. Individuals with requirement of supplemental oxygen to maintain oxygen saturations >94%
  6. Individuals with uncontrolled hypotension (systolic blood pressure < 90 mmHg) or need for vasopressor/inotropic medication
  7. Individuals with renal impairment (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)
  8. Individuals with gastrointestinal symptoms that require hospitalization (e.g. severe nausea, vomiting, diarrhea or/and abdominal pain)
  9. 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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Canada, Ontario
KGK Science Inc.
London, Ontario, Canada, N6A 5R8
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 10, 2020
Last Verified: July 2020
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
Additional relevant MeSH terms:
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Asthma
Pulmonary Eosinophilia
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hypereosinophilic Syndrome
Eosinophilia
Leukocyte Disorders
Hematologic Diseases