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

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ClinicalTrials.gov Identifier: NCT04349540
Recruitment Status : Active, not recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Information provided by (Responsible Party):
Great Ormond Street Hospital for Children NHS Foundation Trust

Brief Summary:

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.


Condition or disease Intervention/treatment
COVID19 Other: no intervention

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.

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : April 15, 2020
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : January 15, 2021

Intervention Details:
  • Other: no intervention
    no intervention


Primary Outcome Measures :
  1. Comparison of inflammatory/immunological biomarkers <72 hours after development of oxygen requirement [ Time Frame: 72 hrs ]

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

Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04349540


Locations
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United Kingdom
Great Ormond Street Hospital NHS Foundation Trust
London, United Kingdom, WC1N 3 JH
Sponsors and Collaborators
Great Ormond Street Hospital for Children NHS Foundation Trust
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Responsible Party: Great Ormond Street Hospital for Children NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04349540    
Other Study ID Numbers: 20BO08
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: April 16, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Great Ormond Street Hospital for Children NHS Foundation Trust:
HSCT