Status:
COMPLETED
Investigation of the Efficacy of CARDIO Softgels PLUS Best-standard-of-care in the Recovery of Patients With COVID-19
Lead Sponsor:
Hofseth Biocare ASA
Collaborating Sponsors:
KGK Science Inc.
Conditions:
COVID
Covid-19
Eligibility:
All Genders
18-75 years
Phase:
NA
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 m...
Detailed Description
SARS-CoV-2, a plus-sense single-stranded RNA virus, is the etiologic agent of COVID-19. After an incubation period, which typically lasts for 5-6 days. COVID-19 patients present with a mild illness th...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2021
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04465513
Start Date
August 31 2020
End Date
October 4 2021
Last Update
October 5 2021
Active Locations (8)
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1
Hospital Universitario Cassiano Antonio de Morais
Vitória, Espírito Santo, Brazil, 29041-295
2
- Instituto de Pesquisa Clínica de Campinas
Campinas, Brazil, 13060-080
3
Instituto Santa Marta de Ensino e Pesquisa
Taguatinga, Brazil, 72025-072
4
KGK Science Inc.
London, Ontario, Canada, N6A 5R8