COVID19(COVID19_BMT)NCT04349540
Role of Immune and Inflammatory Response in Recipients of Allogeneic Haematopoietic Stem Cell Transplantation (SCT) Affected by Severe COVID19
An observational study of COVID19, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 months and older
- Conditions the study is for
- COVID19
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2020to 15 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patinets who develop severe COVID19 infection (defined as requiring oxygen support) after having received an allogeneic stem cell transplantation
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Great Ormond Street Hospital NHS Foundation Trust
London, WC1N 3 JH
About this study
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
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.
Read the 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.
- Conditions
- COVID19
- Being tested
- no intervention
- Keywords
- HSCT
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of inflammatory/immunological biomarkers <72 hours after development of oxygen requirement
Measured: 72 hrs
Secondary outcomes (4)
Overall survival at 30 and 100 days after development of oxygen requirement
Measured: day +30 and +100
Comparison of 30 and 100 day survival in SCT patients who are vs are not ongoing immunosuppression
Measured: Day +30 and +100
Proportion of patients requiring mechanical ventilation
Measured: Day +30
Incidence of secondary HLH (as defined by HS score)
Measured: Day +30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start15 Apr 2020
- Primary completion15 Oct 2020 (estimated)
- Study completion15 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349540
- Sponsor's protocol ID
- 20BO08
- Acronym
- (COVID19_BMT)
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04349540
- Acronym / sponsor ID
- (COVID19_BMT) / 20BO08
- Conditions
- COVID19
- Keywords
- HSCT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Apr 2020 (actual)
- Primary completion
- 15 Oct 2020 (estimated)
- Study completion
- 15 Jan 2021 (estimated)
- First posted
- 16 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patinets who develop severe COVID19 infection (defined as requiring oxygen support) after having received an allogeneic stem cell transplantation
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionno intervention | Other | – |
Primary outcome
Comparison of inflammatory/immunological biomarkers <72 hours after development of oxygen requirement
Time frame: 72 hrs
4 secondary outcomes
Overall survival at 30 and 100 days after development of oxygen requirement
Time frame: 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
Proportion of patients requiring mechanical ventilation
Time frame: Day +30
Incidence of secondary HLH (as defined by HS score)
Time frame: Day +30
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID19, run by Great Ormond Street Hospital for Children NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of inflammatory/immunological biomarkers <72 hours after development of oxygen requirement (time frame: 72 hrs). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2020.