Status:
COMPLETED
Evaluating the Impact of EnteraGam In People With COVID-19
Lead Sponsor:
Entera Health, Inc
Collaborating Sponsors:
Lemus Buhils, SL
Clinical Research Unit, IMIM (Hospital del Mar Medical Research Institute)
Conditions:
Covid19
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Background: Coronavirus Disease 2019 (COVID-19), caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), emerged as a potentially life-threatening disease in Wuhan, China, at the end ...
Detailed Description
Subject population: Outpatient and inpatient male and non-pregnant females ≥18 years old, diagnosed with COVID-19 in the emergency department or admitted to the hospital but not requiring invasive me...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04682041
Start Date
December 22 2020
End Date
February 21 2022
Last Update
April 20 2023
Active Locations (1)
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1
Hospital del Mar
Barcelona, Spain, 08003