COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04682041

Güerri Fernández R

None

2020-12-23

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

inclusion criteria: subject is ≥18 years of age. male or female. females of childbearing (reproductive) potential must have a negative urine pregnancy test at screening. subject with diagnosis of covid-19 based on + rna or immunoglobulin m (igm) test or compatible clinical presentation* who: is being discharged from the emergency department without hospitalization, or is admitted to the hospital or was previously hospitalized and still in the hospital, does not require invasive mechanical ventilation and does not require management in the intensive care unit. inpatients can be enrolled in the study at any time of their hospitalization, if they comply with the inclusion criteria. (*)compatible clinical presentation will consider compatible symptoms (cough, fever, myalgia, dyspnea, ageusia / anosmia) and examination of general condition, heart rate and respiratory rate, oxygen saturation, cardiopulmonary auscultation, compatible radiology. ability to consume enteragam. subject or surrogate decision maker is capable of understanding the requirements of the study, understands the language of the informed consent form, and is capable and willing to sign the informed consent form.

female subjects who are pregnant or breast-feeding. subject is enrolled in another randomized clinical trial. subject is taking anti-il-6 treatment (e.g. tocilizumab), anti-il-1 treatment (e.g. canakinumab, anakinra), or other biologic immunomodulators or immunosuppressant drugs. note: topical/inhaled immunomodulators and corticosteroids are not restricted. subject has immediate need for gi surgery or intervention for active gi bleeding, pancreatitis, peritonitis, intestinal obstruction, or intra-abdominal abscess. subject has active inflammatory bowel disease (e.g., ulcerative colitis, crohn's disease, or celiac disease), gi malignancy, gi obstruction, pancreatitis, gastroparesis, carcinoid syndrome, amyloidosis, ileus, or cholelithiasis. subject has active gastric ulcer, duodenal ulcer, diverticulitis, colitis, enteritis, infectious gastroenteritis, or gi neoplasm, other than benign polyps. subject has a history of allergy or intolerance to beef or to any ingredient in the product. subject has active drug or alcohol abuse that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. history of uncontrolled psychiatric disorders (includes significant depression or suicidal ideation), that in the opinion of the investigator may interfere with the subject's ability to comply with this protocol. in the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours.

2

Entera Health, Inc

18

100

Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

200

Change in plasma IL-6 levels;COVID-19 disease progression by Week 2

None

Not reported

[{"arm_notes": "10.0 g, containing 5.0 g of serum-derived bovine immunoglobulin/protein isolate (SBI) BID (every 12 hours) for 2 weeks ", "treatment_id": 229, "treatment_name": "Bovine plasma-derived immunoglobulin concentrate", "treatment_type": "Immunoglobulins", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]