Covid19Phase 3FeMToCOVIDNCT04824222

The Impact of Fecal Microbiota Transplantation as an Immunomodulation on the Risk Reduction of COVID-19 Disease Progression With Escalating Cytokine Storm and Inflammatory Parameters

A Phase 3 study testing Human fecal microbiota, MBiotix HBI and SOC in people with Covid19, run by Medical University of Warsaw.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: Human fecal microbiota, MBiotix HBI and SOC
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 366 participants
Where: No sites listed yet
Study dates: Apr 2021to Dec 2022
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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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

Who cannot join

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.

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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.

Trial locations and contacts

No sites are listed yet.

Jarosław Biliński, MD, PhD contact

0048225992818

jaroslaw.bilinski@gmail.com

About this study

Official title: Two-stage Study: Phase II/III - With a Pilot Safety Assessment in an Open-label Study and Phase III - a Multicentre, Randomized, Double-blind, Placebo-controlled Evaluation of the Effect of Fecal Microbiota Transplantation as an Immunomodulation, in Addition to Standard Therapy, on the Risk Reduction of COVID19 Disease Progression With Escalating Cytokine Storm and Inflammation

The gut microbiota provides an intestinal biological barrier against pathogens and has a pivotal role in the maintenance of intestinal homeostasis and modulation of the host immune system. The gut microbiota in a dysbiotic state has increasingly been implicated in the pathogenesis and progression of numerous diseases. However, whether dysbiosis reflects changes caused by the disease itself, or should be considered as a driving step in the pathogenesis, is not always understood. Dysbiosis results in the disturbance of several metabolic pathways that influence immunological and mechanical processes both in and outside the intestine, and it impairs colonization resistance. These processes may be reverted by fecal microbiota transplantation (FMT). FMT is a type of treatment that relies on transferring the microbiota that targets and corrects intestinal dysbiosis. FMT is based on collecting stool from healthy donors and - after preparation - administering the material to an individual with a specific disease.

In summary, a subset of the symptoms associated with COVID-19 during the initial phase are intestinal complications, such as vomiting or diarrhea. Detecting these symptoms might not only lead to slowdown in transmission but also open the door to novel treatments that could reduce the severity of COVID-19.There is a positive correlation between severity of patient condition and level of proinflammatory cytokines (cytokine storm) in group of patients with COVID 19. Though numerous studies have been published on FMT for the treatment of certain diseases, there are only scarce studies on FMT for the treatment of SARS-CoV-2. Antiviral mechanism depended on the gut-lung axis was intimately proved in case of flu virus. The same dependency is observed in SARS CoV2 as well. That seems, good condition of intestinal microbiota could impact on antiviral effects and inhibits replication of virus. This leads to inhibit progress of inflammatory process in lung tissue. Silencing of inflammatory process through reestablish right influence of gut-lung axis could be fundamental meaning in arresting of cytokines storm and development of ARDS in patients with COVID-19.

The scientist rationale definitely argue a clear need to studies of gut wellbeing in COVID 19 and using FMT to reduce development of COVID 19. According to our knowledge FeMToCOVID will be the first clinical trial with using of FMT in COVID 19. We postulate FMT in the beginning of cytokine storm during CIVUD-19 may act as an immunomodulation and stop the progression of the disease.

Conditions: Covid19
Being tested: Human fecal microbiota, MBiotix HBI, Placebo, SOC
Keywords: COVID 19, FMT, fecal microbiota transplantation, MBiotix HBI, gut-lung axis
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Human fecal microbiota, MBiotix HBIDrug
Also called MBiotix HBI
The FMT will be administered orally in double cover, gastro-resistant, enteric release capsules in 60g dose (about 30-50 frozen capsules).
PlaceboDrug
Double cover, gastro-resistant, enteric release capsules with lactose (about 30-50 frozen capsules)
SOCDrug
The standard COVID 19 pharmacological treatment

Study groups in NCT04824222
Study group	Role	What they receive
A - SOC+IMP	Experimental	The FMT (fecal microbiota transplantation) will be administered along with the standard COVID 19 pharmacological treatment (SOC- Standard of care). The FMT will be administered orally in one dose - in double cover, gastro-resistant, enteric release capsules in 60g dose (about 30-50 frozen capsules). Receives: Drug: Human fecal microbiota, MBiotix HBI; Drug: SOC
B - SOC+placebo	Placebo comparator	Using standard COVID 19 pharmacological treatment (SOC- Standard of care). The placebo will be administered orally in one dose - in double cover, gastro-resistant, enteric release capsules with lactose (about 30-50 frozen capsules). Receives: Drug: Placebo; Drug: SOC

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of adverse events after administration of IMP in the phase II/III
The incidence of adverse events up to day 30 after administration of the product in the safety pilot group
Measured: 30 days
Percentage of patients requiring escalation of oxygen therapy in non-invasive and invasive methods in phase III
Percentage of patients in the study and control groups requiring escalation of oxygen therapy in non-invasive methods (increasing FiO2 and / or the use of HFNOT and / or other non-invasive methods, e.g. CPAP) and / or invasive ventilation, ventilator therapy and / or hospitalization in the intensive care unit (corresponding to disease exacerbation at grade 5-7 on the COVID-19 Performance Status scale)
Measured: 100 days

Secondary outcomes (13)

Mortality during hospitalization, up to 14, 30, 60 and 100 days of observation in the study and control groups,
Measured: 14, 30, 60, 100 days
The number of complications secondary to COVID-19 (bacterial, fungal infections, sepsis, septic shock, multi-organ failure) by the 30th day of observation;
Measured: 30 days
COVID-19 Performance Status score during hospitalization from randomization to discharge from hospital or death, and to day 14 and 30 of observation in the study and control groups
Measured: 14, 30 days
The maximum degree of COVID-19 disease severity assessed in the COVID-19 Performance Status scale during hospitalization (until discharge from hospital or death)
Measured: until discharge or death
NEWS (National Early Warning Score) 2 scores during hospitalization from randomization to discharge from hospital or death in the study and control groups
Measured: until discharge or death
Assessment of the number of patients who were not able to take all capsules despite the lack of swallowing disorders in the initial evaluation,
Measured: hospitalization
The number of days with fever (temperature above 38.0°C) up to the 30th day of observation in the study and control groups,
Measured: 30 days
Number of hospitalization days up to the 30th day of observation in the study and control groups
Measured: 30 days
Number of days of stay in the intensive care unit until the 30th day of observation in the study and control groups
Measured: 30 days
Number of days of mechanical ventilation in convalescents up to the 30th day of observation in the study and control groups (if applicable)
Measured: 30 days
The number of days of non-invasive ventilation in convalescents up to the 30th day of observation in the study and control groups (if applicable)
Measured: 30 days
Number of days of passive oxygen therapy in convalescents up to the 30th day of observation in the study and control groups (if applicable)
Measured: 30 days
Safety of treatment up to day 100 of follow-up in the study and control and pilot groups (type, frequency, severity of adverse events [AE])
Measured: 100 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2021Dec 2022

First posted1 Apr 2021
Study startApr 2021 (estimated)
Primary completionJul 2022 (estimated)
Study completionDec 2022 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Covid19Studies of the same condition, open and under way.
More trials run by Medical University of WarsawThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Phase II/III : 20 subjects - standard of care (SOC) + FMT capsules Phase III : 173 subjects - arm with SOC + FMT capsules 173 subjects - arm with SOC + Placebo capsules
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 366 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04824222
Sponsor's protocol ID: FeMToCOVID
Other IDs: 2020-003915-84
Acronym: FeMToCOVID
Status last verified: Mar 2021
First submitted: 26 Mar 2021
Last updated: 1 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Jarosław Biliński, MD, PhD

0048225992818

jaroslaw.bilinski@gmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Two-stage Study: Phase II/III - With a Pilot Safety Assessment in an Open-label Study and Phase III - a Multicentre, Randomized, Double-blind, Placebo-controlled Evaluation of the Effect of Fecal Microbiota Transplantation as an Immunomodulation, in Addition to Standard Therapy, on the Risk Reduction of COVID19 Disease Progression With Escalating Cytokine Storm and Inflammation
ClinicalTrials.gov ID: NCT04824222
Acronym / sponsor ID: FeMToCOVID / FeMToCOVID
Conditions: Covid19
Keywords: COVID 19, FMT, fecal microbiota transplantation, MBiotix HBI, gut-lung axis
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 366 participants (estimated)
Lead sponsor: Medical University of WarsawUniversity, hospital or other
Collaborators: Human Biome S.A.
Study start: Apr 2021 (estimated)
Primary completion: Jul 2022 (estimated)
Study completion: Dec 2022 (estimated)
First posted: 1 Apr 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Phase II/III : 20 subjects - standard of care (SOC) + FMT capsules Phase III : 173 subjects - arm with SOC + FMT capsules 173 subjects - arm with SOC + Placebo capsules

Arm	Type	Receives
A - SOC+IMP	Experimental	Drug: Human fecal microbiota, MBiotix HBI, Drug: SOCThe FMT (fecal microbiota transplantation) will be administered along with the standard COVID 19 pharmacological treatment (SOC- Standard of care). The FMT will be administered orally in one dose - in double cover, gastro-resistant, enteric release capsules in 60g dose (about 30-50 frozen capsules).
B - SOC+placebo	Placebo comparator	Drug: Placebo, Drug: SOCUsing standard COVID 19 pharmacological treatment (SOC- Standard of care). The placebo will be administered orally in one dose - in double cover, gastro-resistant, enteric release capsules with lactose (about 30-50 frozen capsules).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

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.

Key exclusion criteria (31 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Human fecal microbiota, MBiotix HBIAlso: MBiotix HBIThe FMT will be administered orally in double cover, gastro-resistant, enteric release capsules in 60g dose (about 30-50 frozen capsules).	Drug	A - SOC+IMP
PlaceboDouble cover, gastro-resistant, enteric release capsules with lactose (about 30-50 frozen capsules)	Drug	B - SOC+placebo
SOCThe standard COVID 19 pharmacological treatment	Drug	A - SOC+IMP, B - SOC+placebo

Primary outcome

Incidence of adverse events after administration of IMP in the phase II/III
Time frame: 30 days
The incidence of adverse events up to day 30 after administration of the product in the safety pilot group
Percentage of patients requiring escalation of oxygen therapy in non-invasive and invasive methods in phase III
Time frame: 100 days
Percentage of patients in the study and control groups requiring escalation of oxygen therapy in non-invasive methods (increasing FiO2 and / or the use of HFNOT and / or other non-invasive methods, e.g. CPAP) and / or invasive ventilation, ventilator therapy and / or hospitalization in the intensive care unit (corresponding to disease exacerbation at grade 5-7 on the COVID-19 Performance Status scale)

13 secondary outcomes

Mortality during hospitalization, up to 14, 30, 60 and 100 days of observation in the study and control groups,
Time frame: 14, 30, 60, 100 days
The number of complications secondary to COVID-19 (bacterial, fungal infections, sepsis, septic shock, multi-organ failure) by the 30th day of observation;
Time frame: 30 days
COVID-19 Performance Status score during hospitalization from randomization to discharge from hospital or death, and to day 14 and 30 of observation in the study and control groups
Time frame: 14, 30 days
The maximum degree of COVID-19 disease severity assessed in the COVID-19 Performance Status scale during hospitalization (until discharge from hospital or death)
Time frame: until discharge or death
NEWS (National Early Warning Score) 2 scores during hospitalization from randomization to discharge from hospital or death in the study and control groups
Time frame: until discharge or death
Assessment of the number of patients who were not able to take all capsules despite the lack of swallowing disorders in the initial evaluation,
Time frame: hospitalization
The number of days with fever (temperature above 38.0°C) up to the 30th day of observation in the study and control groups,
Time frame: 30 days
Number of hospitalization days up to the 30th day of observation in the study and control groups
Time frame: 30 days
Number of days of stay in the intensive care unit until the 30th day of observation in the study and control groups
Time frame: 30 days
Number of days of mechanical ventilation in convalescents up to the 30th day of observation in the study and control groups (if applicable)
Time frame: 30 days
The number of days of non-invasive ventilation in convalescents up to the 30th day of observation in the study and control groups (if applicable)
Time frame: 30 days
Number of days of passive oxygen therapy in convalescents up to the 30th day of observation in the study and control groups (if applicable)
Time frame: 30 days
Safety of treatment up to day 100 of follow-up in the study and control and pilot groups (type, frequency, severity of adverse events [AE])
Time frame: 100 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jarosław Biliński, MD, PhD contact

0048225992818

jaroslaw.bilinski@gmail.com

Jarosław Biliński, MD, PhD principal investigator

Medical University of Warsaw

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Human fecal microbiota, MBiotix HBI and SOC in people with Covid19, run by Medical University of Warsaw.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jarosław Biliński, MD, PhD (0048225992818, jaroslaw.bilinski@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events after administration of IMP in the phase II/III (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04824222.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.