NCT04824222

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Medical University of Warsaw · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Interventions

Type	Name	Description
DRUG	Human fecal microbiota, MBiotix HBI	The FMT will be administered orally in double cover, gastro-resistant, enteric release capsules in 60g dose (about 30-50 frozen capsules).
DRUG	Placebo	Double cover, gastro-resistant, enteric release capsules with lactose (about 30-50 frozen capsules)
DRUG	SOC	The standard COVID 19 pharmacological treatment

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-07-01
• Completion: 2022-12-01
• First posted: 2021-04-01
• Last updated: 2021-04-01