NCT04251767

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

February 5, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

January 30, 2020

Last Update Submit

March 13, 2020

Conditions

COVID-19 Complicated With Refractory Intestinal Infections

Keywords

COVID-19SARS-CoV-22019-nCoVFecal Microbiota TransplantationWashed Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

  • Number of participants with improvement from severe type to common type

    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.

    2 weeks

Study Arms (2)

Observational group

EXPERIMENTAL

5u washed microbiota suspension administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.

Other: washed microbiota transplantation

Control group

PLACEBO COMPARATOR

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.

Other: placebo

Interventions

washed microbiota transplantationOTHER

Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5u, once.

Also known as: microbiota transplantation, fecal microbiota transplantation
Observational group
placeboOTHER

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.

Also known as: edible suspension
Control group

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • novel coronavirus pneumonia (severe type)
  • Subjects voluntarily participate in the clinical trial and sign the informed consent

You may not qualify if:

  • Disturbance of consciousness
  • Difficulty swallowing and frequent vomiting
  • Patients requiring blood transfusion
  • Pulmonary abscess, hepatitis, cirrhosis, tuberculosis, emphysema and pulmonary infarction
  • Fungal and other identified pathogens infection
  • Heart failure existed before diagnosis of novel coronavirus infection
  • Liver function: alanine aminotransferase \> 500 U/L
  • Patients requiring hemodialysis
  • Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases
  • Other conditions that the investigator considers ineligible for clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Related Publications (11)

  • Bradley KC, Finsterbusch K, Schnepf D, Crotta S, Llorian M, Davidson S, Fuchs SY, Staeheli P, Wack A. Microbiota-Driven Tonic Interferon Signals in Lung Stromal Cells Protect from Influenza Virus Infection. Cell Rep. 2019 Jul 2;28(1):245-256.e4. doi: 10.1016/j.celrep.2019.05.105.

    PMID: 31269444BACKGROUND

  • Dai M, Liu Y, Chen W, Buch H, Shan Y, Chang L, Bai Y, Shen C, Zhang X, Huo Y, Huang D, Yang Z, Hu Z, He X, Pan J, Hu L, Pan X, Wu X, Deng B, Li Z, Cui B, Zhang F. Rescue fecal microbiota transplantation for antibiotic-associated diarrhea in critically ill patients. Crit Care. 2019 Oct 21;23(1):324. doi: 10.1186/s13054-019-2604-5.

    PMID: 31639033BACKGROUND

  • Ding X, Li Q, Li P, Zhang T, Cui B, Ji G, Lu X, Zhang F. Long-Term Safety and Efficacy of Fecal Microbiota Transplant in Active Ulcerative Colitis. Drug Saf. 2019 Jul;42(7):869-880. doi: 10.1007/s40264-019-00809-2.

    PMID: 30972640BACKGROUND

  • Dominguez-Diaz C, Garcia-Orozco A, Riera-Leal A, Padilla-Arellano JR, Fafutis-Morris M. Microbiota and Its Role on Viral Evasion: Is It With Us or Against Us? Front Cell Infect Microbiol. 2019 Jul 18;9:256. doi: 10.3389/fcimb.2019.00256. eCollection 2019.

    PMID: 31380299BACKGROUND

  • Ekbom A, Brandt L, Granath F, Lofdahl CG, Egesten A. Increased risk of both ulcerative colitis and Crohn's disease in a population suffering from COPD. Lung. 2008 May-Jun;186(3):167-172. doi: 10.1007/s00408-008-9080-z. Epub 2008 Mar 11.

    PMID: 18330638BACKGROUND

  • Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24.

    PMID: 31986264BACKGROUND

  • London AJ. Social value, clinical equipoise, and research in a public health emergency. Bioethics. 2019 Mar;33(3):326-334. doi: 10.1111/bioe.12467. Epub 2018 Jul 27.

    PMID: 30051635BACKGROUND

  • Marsland BJ, Trompette A, Gollwitzer ES. The Gut-Lung Axis in Respiratory Disease. Ann Am Thorac Soc. 2015 Nov;12 Suppl 2:S150-6. doi: 10.1513/AnnalsATS.201503-133AW.

    PMID: 26595731BACKGROUND

  • Ng SC, Kamm MA, Yeoh YK, Chan PKS, Zuo T, Tang W, Sood A, Andoh A, Ohmiya N, Zhou Y, Ooi CJ, Mahachai V, Wu CY, Zhang F, Sugano K, Chan FKL. Scientific frontiers in faecal microbiota transplantation: joint document of Asia-Pacific Association of Gastroenterology (APAGE) and Asia-Pacific Society for Digestive Endoscopy (APSDE). Gut. 2020 Jan;69(1):83-91. doi: 10.1136/gutjnl-2019-319407. Epub 2019 Oct 14.

    PMID: 31611298BACKGROUND

  • Wang H, Cui B, Li Q, Ding X, Li P, Zhang T, Yang X, Ji G, Zhang F. The Safety of Fecal Microbiota Transplantation for Crohn's Disease: Findings from A Long-Term Study. Adv Ther. 2018 Nov;35(11):1935-1944. doi: 10.1007/s12325-018-0800-3. Epub 2018 Oct 16.

    PMID: 30328062BACKGROUND

  • Zhang T, Lu G, Zhao Z, Liu Y, Shen Q, Li P, Chen Y, Yin H, Wang H, Marcella C, Cui B, Cheng L, Ji G, Zhang F. Washed microbiota transplantation vs. manual fecal microbiota transplantation: clinical findings, animal studies and in vitro screening. Protein Cell. 2020 Apr;11(4):251-266. doi: 10.1007/s13238-019-00684-8. Epub 2020 Jan 9.

    PMID: 31919742BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • Faming Zhang, MD; PHD

    The Second Hospital of Nanjing Medical University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Medical Center for Digestive Diseases

Study Record Dates

First Submitted

January 30, 2020

First Posted

February 5, 2020

Study Start

February 5, 2020

Primary Completion

April 30, 2020

Study Completion

April 30, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)