Role of Immune and Inflammatory Response in Recipients of Allogeneic Haematopoietic Stem Cell Transplantation (SCT) Affected by Severe COVID19 ((COVID19_BMT))

A Prospective Non Interventional Study to Evaluate the Role of Immune and Inflammatory Response in Recipients of Allogeneic Haematopoietic Stem Cell Transplantation (SCT) Affected by Severe COVID19 Infection

COVID19 pandemic currently represents a public health emergency. Based on current data, 15% of the affected individuals will develop a severe form of the disease requiring admission to hospital and respiratory support. Data show that age and cardiovascular pre-existing comorbidities predict a poorer outcome. Some evidence suggests that a subset of patients with poorer outcome present with a cytokine mediated inflammatory response and with a secondary HLH like clinical phenotype. No data are so far available with regard to the risk of severe COVID19 disease in the post stem cell transplantation setting. Recipients of allogeneic stem cell transplantation are by definition immunologically dysregulated and could potentially present with a unique immune-inflammatory response to COVID 19 infection. Moreover, the immunosuppression used to prevent/treat GVHD may also impact clinical progression and it is possible that because of their immunological defects, SCT patients could potentially have prolonged carriage of the virus and hence act as "super spreaders".

The present study aims at documenting clinical and biological characteristics, including immunological profiling, of allogeneic stem cell transplant recipients presenting with severe COVID 19 infection and its impact on patients survival. This work may provide the scientific basis for targeted therapy with biological agents in this patient group.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The transplant teams in each participating site will be identifying and approaching eligible patients. Adult and paediatric patients with a history of allogeneic stem cell transplantation who are admitted to hospital with a proven severe COVID19 infection will be eligible for the study. Within 72 hrs of admission, a 10 ml clotted blood (5 mls for pts below 15 kg weight) will be collected and serum frozen at -80 C. This sample will be sent with a 10ml blood sample (5 mls for pts below 15 kg weight) in EDTA to the Immunology Laboratories at Great Ormond Street Hospital (GOSH) in London for centralized cytokine and lymphocyte subset analysis. The sample will be divided into 2 aliquots, one being analyzed directly, the second one being frozen for further assays as developed. Other immunological and biochemical parameters will be tested locally and results with local reference ranges will be collected for the purpose of the current study.

In case the patient deteriorates further from the respiratory perspective requiring either CPAP or mechanical ventilation, a second 5 ml serum sample may be collected, frozen at -80 C and sent to GOSH for repeated cytokine analysis.

HScore will be calculated as per published data but bone marrow aspiration will be optional in calculating the scoring given the expected acute clinical situation of the patient. (Fardet et al, Arthritis Rheumatol 2014).

Transplant research team members will collect demographic and clinical characteristics at the time samples are sent to GOS. Blood results, data on clinical course, therapy (including biological agents) and outcome data will be collected with a follow up survey 30 and 100 days after start of supplemental oxygen therapy for COVID19 infection.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • London, United Kingdom, WC1N 3 JH
        • Great Ormond Street Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

all patinets who develop severe COVID19 infection (defined as requiring oxygen support) after having received an allogeneic stem cell transplantation

Description

Inclusion Criteria:

  1. Adult and paediatric patents (any age) who have received allogeneic stem cell transplantation AND
  2. Proven COVID19 infection as documented by PCR testing of nasal/ throat swab or NPA AND
  3. Severe COVID 19 infection as defined by need for supplemental oxygen

Exclusion Criteria:

  1. Patients beyond the first 72 hours of developing oxygen requirement or
  2. Patients who have received cytokine targeting treatment before blood sampling or
  3. Patients with a mild/moderate COVID19 infection (ie no need for supplementary oxygen)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of inflammatory/immunological biomarkers <72 hours after development of oxygen requirement
Time Frame: 72 hrs
72 hrs

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival at 30 and 100 days after development of oxygen requirement
Time Frame: day +30 and +100
day +30 and +100
Comparison of 30 and 100 day survival in SCT patients who are vs are not ongoing immunosuppression
Time Frame: Day +30 and +100
Day +30 and +100
Proportion of patients requiring mechanical ventilation
Time Frame: Day +30
Day +30
Incidence of secondary HLH (as defined by HS score)
Time Frame: Day +30
Day +30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2020

Primary Completion (ANTICIPATED)

October 15, 2020

Study Completion (ANTICIPATED)

January 15, 2021

Study Registration Dates

First Submitted

April 14, 2020

First Submitted That Met QC Criteria

April 14, 2020

First Posted (ACTUAL)

April 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 14, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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