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

NCT04465513 | Completed

• 1 other identifier: 20CCHH
• Study Type: interventional
• Target: 14
• Locations: 5 countries
• Sites: 8

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.

Conditions

COVID; Covid-19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Clinical improvement

  Day 10, Day 14, Day 28, or Day of discharge

• Clinical status

  Day 10, Day 14, Day 28, or Day of discharge

• Time to clinical recovery

  Day 28 or Day of discharge

• Time to improvement in oxygenation for at least 48 hours

  Day 28 or Day of discharge

• Quality of life (QoL)

  Day 0, Day 10, Day 14, and Day 28

Other Outcomes (18)

• Adverse Events

  Day 0 and up to day 28

• Blood pressure

  Day 0 and up to day 28

• Heart rate

  Day 0 and up to day 28

Study Arms (2)

Best Standard of Care + CARDIO

ACTIVE COMPARATOR

Combination of CARDIO and Best Standard of Care

Dietary Supplement: Best Standard of Care + CARDIO

Best Standard of Care

PLACEBO COMPARATOR

Placebo and Best Standard of Care

Dietary Supplement: Best Standard of Care

Interventions

Best Standard of Care + CARDIO DIETARY_SUPPLEMENT

Combination of dietary supplement with clinical care

Best Standard of Care + CARDIO

Best Standard of Care DIETARY_SUPPLEMENT

Combination of placebo with clinical care

Best Standard of Care

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with signs and symptoms corresponding to COVID-19 viral infection and:
• 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
• 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
• Males and females between 18 and 75 years of age, inclusive
• 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
• Willingness to complete assessments, questionnaires and records associated with the study
• Provided voluntary, written, informed consent to participate in the study

You may not qualify if:

• Women who are pregnant, breast feeding, or planning to become pregnant during the study
• Inability to take medications orally
• Individuals with a known fish allergy or hypersensitivity reaction
• Individuals with uncontrolled hypotension (systolic blood pressure \< 90 mmHg) or need for vasopressor/inotropic medication
• 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)
• 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.

Sponsors & Collaborators

• Hofseth Biocare ASA: lead
• KGK Science Inc.: collaborator

Study Sites (8)

Hospital Universitario Cassiano Antonio de Morais

Vitória, Espírito Santo, 29041-295, Brazil

Location

- Instituto de Pesquisa Clínica de Campinas

Campinas, 13060-080, Brazil

Location

Instituto Santa Marta de Ensino e Pesquisa

Taguatinga, 72025-072, Brazil

Location

KGK Science Inc.

London, Ontario, N6A 5R8, Canada

Location

Markhot Ferenc Oktatókórház és Rendelőintézet, Eger

Eger, 3300, Hungary

Location

Albert Schweitzer Kórház-Rendelőintézet, Hatvan

Hatvan, 3000, Hungary

Location

The American British Cowdray Medical Center I.A.P.

Mexico City, 01120, Mexico

Location

General Hospital Paracin

Paraćin, 35250, Serbia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 10, 2020
• Study Start: August 31, 2020
• Primary Completion: October 4, 2021
• Study Completion: October 4, 2021
• Last Updated: October 5, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); SE (1); BR (3); HU (2); CA (1)