Efficacy and Safety of Washed Microbiota Transplantation to Treat Patients with Mild-to-Severe COVID-19 and Suspected of Having Gut Microbiota Dysbiosis: Study Protocol for a Randomized Controlled Trial.

OBJECTIVE: Coronavirus disease 2019 (COVID-19) is often accompanied by gastrointestinal symptoms, which are related to gut microbiota dysbiosis (GMD). Whether washed microbiota transplantation (WMT) is an effective treatment for COVID-19 patients suspected of having GMD by restoring the gut microbiota is unknown. This study is designed to explore the efficacy and safety of WMT in COVID-19 patients suspected of having GMD. METHODS: This is a randomized, multicenter, single-blind prospective study. COVID-19 patients suspected of having GMD will be randomly divided to receive routine treatment only or to receive routine treatment and WMT. The frequency of WMT will be once a day for three consecutive days. Laboratory and imaging examinations will be performed at admission, 1 and 2 weeks after treatment, and on the day of discharge. Then a telephone follow-up will be conducted at 1st week, 2nd week, and 6th month after discharge. The clinical efficacy and safety of WMT in COVD-19 patients suspected of having GMD and the effects of WMT on the organ function, homeostasis, inflammatory response, intestinal mucosal barrier function, and immunity of the patients will be evaluated. RESULTS: By following the proposed protocol, WMT is expected to be efficacious and safe for the treatment of COVID-19 patients suspected of having GMD, and the therapeutic effect is expected to be associated with improvement of the intestinal mucosal barrier function, inflammatory response, and immunity. CONCLUSION: The findings from this study may offer a new approach for the prevention and treatment of COVID-19 patients suspected of having GMD.

Treatment of COVID-19 patients suspected with gut microbiota dysbiosis with washed microbiota transplantation: study protocol for a randomized controlled trial (preprint)

BACKGROUND: Coronavirus disease 2019 (COVID-19) is often accompanied by gastrointestinal symptoms, which is related to gut microbiota dysbiosis (GMD). Whether washed microbiota transplantation (WMT) is effective in COVID-19 patients suspected with GMD by restoring gut microbiota is unknown. This study is designed to explore the efficacy and safety of WMT in COVID-19 patients suspected with GMD.METHODS: COVID-19 patients suspected with GMD will be randomly divided to receive routine treatment (group A) or receive routine treatment and WMT (group B). The frequency of WMT will be once a day for three consecutive days. Nucleic acid test, imaging examination, and tests related to organ functions, homeostasis, inflammatory response, intestinal barrier function and immunity will be performed at admission, 1, and 2 weeks after treatment and on the day of discharge. The clinical efficacy and safety of WMT in COVD-19 suspected with GMD and the effects of WMT on the organ function, homeostasis, inflammatory response, intestinal barrier function and immunity of the patients will be evaluated. The primary outcome will be the clinical efficacy, as reflected by the SARS-Cov-2 infection status, gastrointestinal symptoms and the recovery of the disease. The secondary outcomes will be the effects of WMT on the organ function, homeostasis, inflammatory response, intestinal barrier function and immunity of the patients, as well as occurrence of adverse events during WMT.DISCUSSION: In the proposed protocol, WMT is expected to be efficacious and safe for the treatment of COVID-19 patients suspected with GMD, and the therapeutic effect is expected to be associated with the improvement of intestinal barrier function, inflammatory response and immunity. Findings from this study may open up a new way for the prevention and treatment of COVID-19 suspected with GMD.TRIAL REGISTRATION: Chinese Clinical Trial Registry – URL: http://www.chictr.org.cn/index.aspx. Registration number: ChiCTR2000032737. Registered 9 May 2020.

Aerodynamic Characteristics and RNA Concentration of SARS-CoV-2 Aerosol in Wuhan Hospitals during COVID-19 Outbreak (preprint)

BackgroundThe ongoing outbreak of COVID-19 has spread rapidly and sparked global concern. While the transmission of SARS-CoV-2 through human respiratory droplets and contact with infected persons is clear, the aerosol transmission of SARS-CoV-2 has been little studied. MethodsThirty-five aerosol samples of three different types (total suspended particle, size segregated and deposition aerosol) were collected in Patient Areas (PAA) and Medical Staff Areas (MSA) of Renmin Hospital of Wuhan University (Renmin) and Wuchang Fangcang Field Hospital (Fangcang), and Public Areas (PUA) in Wuhan, China during COVID-19 outbreak. A robust droplet digital polymerase chain reaction (ddPCR) method was employed to quantitate the viral SARS-CoV-2 RNA genome and determine aerosol RNA concentration. ResultsThe ICU, CCU and general patient rooms inside Renmin, patient hall inside Fangcang had undetectable or low airborne SARS-CoV-2 concentration but deposition samples inside ICU and air sample in Fangcang patient toilet tested positive. The airborne SARS-CoV-2 in Fangcang MSA had bimodal distribution with higher concentration than those in Renmin during the outbreak but turned negative after patients number reduced and rigorous sanitization implemented. PUA had undetectable airborne SARS-CoV-2 concentration but obviously increased with accumulating crowd flow. ConclusionsRoom ventilation, open space, proper use and disinfection of toilet can effectively limit aerosol transmission of SARS-CoV-2. Gathering of crowds with asymptomatic carriers is a potential source of airborne SARS-CoV-2. The virus aerosol deposition on protective apparel or floor surface and their subsequent resuspension is a potential transmission pathway and effective sanitization is critical in minimizing aerosol transmission of SARS-CoV-2.