COVID-19 Complicated With Refractory Intestinal Infections Clinical Trial
Official title:
Washed Microbiota Transplantation for Patients With 2019-nCoV Infection: a Randomized, Double-blind, Placebo-controlled Study
Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.
An ongoing outbreak of 2019 novel coronavirus was reported in Wuhan, China. 2019-nCoV has
caused a cluster of pneumonia cases, and posed continuing epidemic threat to China and even
global health. Unfortunately, there is currently no specific effective treatment for the
viral infection and the related serious complications. It is in urgent need to find a new
specific effective treatment for the 2019-nCoV infection. According to Declaration of
Helsinki and International Ethical Guidelines for Health-related Research Involving Humans,
the desperately ill patients with 2019-nCov infection during disease outbreaks have a moral
right to try unvalidated medical interventions (UMIs) and that it is therefore unethical to
restrict access to UMIs to the clinical trial context.
There is a vital link between the intestinal tract and respiratory tract, which was
exemplified by intestinal complications during respiratory disease and vice versa. Some of
these patients can develop secondary bacterial infections and antibiotic-associated diarrhea
(AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in
critically ill patients with AAD demonstrated the important clinical benefits and safety of
WMT. Additionally, the recent animal study provided direct evidence supporting that
antibiotics could decrease gut microbiota and the lung stromal interferon signature and
facilitate early influenza virus replication in lung epithelia. Importantly, the above
antibiotics caused negative effects can be reversed by fecal microbiota transplantation (FMT)
which suggested that FMT might be able to induce a significant improvement in the respiratory
virus infection. Another evidence is that the microbiota could confer protection against
certain virus infection such as influenza virus and respiratory syncytial virus by priming
the immune response to viral evasion. The above results suggested that FMT might be a new
therapeutic option for the treatment of virus-related pneumonia. The methodology of FMT
recently was coined as WMT, which is dependent on the automatic facilities and washing
process in a laboratory room. Patients underwent WMT with the decreased rate of adverse
events and unchanged clinical efficacy in ulcerative colitis and Crohn's disease. This
clinical trial aims to evaluate the outcome of WMT combining with standard therapy for
patients with novel coronavirus pneumonia, especially for those patients with
dysbiosis-related conditions.
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