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

NCT04349540 | Unknown

• 1 other identifier: 20BO08
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID19

Keywords

HSCT

Outcome Measures

Primary Outcomes (1)

• Comparison of inflammatory/immunological biomarkers <72 hours after development of oxygen requirement

  72 hrs

Secondary Outcomes (4)

• Overall survival at 30 and 100 days after development of oxygen requirement

  day +30 and +100

• Comparison of 30 and 100 day survival in SCT patients who are vs are not ongoing immunosuppression

  Day +30 and +100

• Proportion of patients requiring mechanical ventilation

  Day +30

• Incidence of secondary HLH (as defined by HS score)

  Day +30

Interventions

no intervention OTHER

no intervention

Eligibility Criteria

• Age: 3 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital NHS Foundation Trust

London, WC1N 3 JH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood samples

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: April 15, 2020
• Primary Completion: October 15, 2020
• Study Completion: January 15, 2021
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)