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Washed Microbiota Transplantation for Patients With 2019-nCoV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251767
Recruitment Status : Withdrawn (Follow new disciplines on disease control from government)
First Posted : February 5, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Faming Zhang, The Second Hospital of Nanjing Medical University

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE February 5, 2020
Last Update Posted Date March 17, 2020
Estimated Study Start Date  ICMJE February 5, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 31, 2020)
Number of participants with improvement from severe type to common type [ Time Frame: 2 weeks ]
Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following): (1) Respiratory distress,respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%;(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following): (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Washed Microbiota Transplantation for Patients With 2019-nCoV Infection
Official Title  ICMJE Washed Microbiota Transplantation for Patients With 2019-nCoV Infection: a Randomized, Double-blind, Placebo-controlled Study
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE COVID-19 Complicated With Refractory Intestinal Infections
Intervention  ICMJE
  • Other: washed microbiota transplantation

    Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral.

    Dose and frequency: 5u, once.

    Other Names:
    • microbiota transplantation
    • fecal microbiota transplantation
  • Other: placebo

    Placebo (edible suspension of the same color as the washed microbiota suspension,5u) administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.

    Dose and frequency: 5u, once.

    Other Name: edible suspension
Study Arms  ICMJE
  • Experimental: Observational group
    5u washed microbiota suspension administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
    Intervention: Other: washed microbiota transplantation
  • Placebo Comparator: Control group
    5 u placebo (edible suspension of the same color as the washed microbiota suspension) administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
    Intervention: Other: placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 13, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: January 31, 2020)
40
Estimated Study Completion Date  ICMJE April 30, 2020
Estimated Primary Completion Date April 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 14-70 years old
  2. 2019 novel coronavirus pneumonia (severe type)
  3. Subjects voluntarily participate in the clinical trial and sign the informed consent

Exclusion Criteria:

  1. Disturbance of consciousness
  2. Difficulty swallowing and frequent vomiting
  3. Patients requiring blood transfusion
  4. Pulmonary abscess, hepatitis, cirrhosis, tuberculosis, emphysema and pulmonary infarction
  5. Fungal and other identified pathogens infection
  6. Heart failure existed before diagnosis of novel coronavirus infection
  7. Liver function: alanine aminotransferase > 500 U/L
  8. Patients requiring hemodialysis
  9. Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases
  10. Other conditions that the investigator considers ineligible for clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 14 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04251767
Other Study ID Numbers  ICMJE WMT-YJ-202001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Faming Zhang, The Second Hospital of Nanjing Medical University
Study Sponsor  ICMJE The Second Hospital of Nanjing Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Faming Zhang, MD; PHD The Second Hospital of Nanjing Medical University
PRS Account The Second Hospital of Nanjing Medical University
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP