COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04824222

Jarosław Biliński, MD, PhD

jaroslaw.bilinski@gmail.com

2021-04-01

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: subject has signed informed consent form and is able to understand the purpose and procedures required for the study and is willing to participate in the study. male or female in aged 18 and older. expected survival time, not taking into account sarscov2 infection, is at least 6 months. diagnosis of covid 19 disease confirmed by sarscov2 pcr test (the validity of test 7 days before the start of screening). hospitalization due to covid 19 disease or disease with accompanied covid 19. any of the following: use of oxygen therapy or oxygen therapy and remdesivir or use of oxygen therapy and convalescent plasma or use of oxygen therapy and remdesivir and convalescents plasma or no necessity of using oxygen therapy but necessity of using remdesivir or convalescents plasma or remdesivir and convalescents plasma (which corresponds to the disease severity of 4-6 points in covid 19 performance status scale). initially escalated inflammatory process, defined as compliance at least 2 parameters from group "a", during 24 hours before including patient to the study or at least one parameter from group "b". group "a": plasma amyloid a to lymphocyte count ratio is greater than 100 (saa/l>100) saa >100mg/l leukocytosis (wbc) over 10 k/ul with absolute lymphopenia under 1,0 k/ul crp >100 mg/l and absolute lymphopenia il-6 >25 pg/ml inflammatory changes in lung assessed based on high resolution computed tomography (hrct) at least 2 points in covid-ct scale. group "b": inflammatory process progression during the hospitalization (optimally during 2 days and maximum during 7 days) compared to starting tests: increase of plasma amyloid a (saa) to lymphocyte count ratio (saa/l) by at least 25% compared to initial result (at least a day before) increase of saa concentration by at least 25% compared to initial result (at least a day before) decline of absolute lymphocyte count in peripheral blood by at least 25% compared to the initial result (from one day ago) increase of crp by at least 50% compared to initial result (at least a day before) increase of il-6 by at least 25% compared to initial result (at least a day before) progression of lung changes in ct compared to initial picture (assessed in covid-ct scale; at least a day before) decline of pao2/fio2 by at least 100 mmhg, but not lower than 200 mmhg

age < 18 years old. inability to obtain informed consent. patient's impaired consciousness in opinion of investigator. swallowing difficulties before sars-cov 2 infection or related to sasrs-cov 2 infection (eg. caused by dyspnea). severe food allergy. at least 7 points in covid-19 performance status. patients, who need blood transfusion in the day of study inclusion. significant intestinal passage disturbance, eg. bowel irritation, bowel obstruction, after bowel or stomach resection etc. diagnosed before covid 19 diagnosis. stoma, perforation or abscess located in gastrointestinal tract area in the past. clinical significant systemic or localised infections, other than covid 19, eg. lung abscess, pleural abscess, hepatitis, tuberculosis, sepsis ect. severe cardiac failure (nyha iii or more) before covid 19 diagnosis. significant higher liver parameters: alanine aminotransferase or aspartate aminotransferase > 500 u/l. important primary or secondary immune dysfunction - eg. aids, severe neutropenia (neutrophiles < 0,5k/ul), inborn immunodeficiency, myelosuppression after chemotherapy etc. necessity of systemic antibiotic therapy in time of screening or inclusion to study. female in reproductive age with positive pregnancy test during screening. breast-feeding female. female after menopause: after an ovariohysterectomy confirmed ovaries inactivity menopause defined as at least 12 months after last menstruation or fsh > 40 iu/l. patients in severe systemic condition, it means comply at least on of the following: need mechanical ventilation ratio of pao2/fio2 lower than 200 mmhg need the vasopressors, because of the shock unconscious patients taking any experimental medication, except remdesivir and convalescents plasma or medication in other clinical trial within 30 days or if the time is shorter than 5 half-lifes, depended which time will be longer before day "0" human immunodeficiency virus infection, active hepatitis b or c virus infection, fresh infection of cmv, ebv or influenza virus. the co-existence of severe systemic disorder, which in opinion of investigator can endanger significant medication interactions or inability to follow protocol lactose intolerance. the inability to administration testing capsule. other, conditions unexpected in protocol, which in opinion of investigator considers excluding from study.

2

Medical University of Warsaw

18

100

None

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

366

Incidence of adverse events after administration of IMP in the phase II/III;Percentage of patients requiring escalation of oxygen therapy in non-invasive and invasive methods in phase III

None

Phase 3

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