COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04465513

Malkanthi Evans, PhD

mevans@kgkscience.com

2020-07-10

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria: 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

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.

2

Hofseth Biocare ASA

18

75

Brazil;Canada;Hungary;Mexico;Serbia

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

14

Proportion of patients requiring mechanical ventilator until end of study (Day 28)

None

Not reported

[{"arm_notes": "", "treatment_id": 517, "treatment_name": "Fish oil", "treatment_type": "Vitamins and dietary supplements", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]