Mechanisms of Multi-organ Failure in COVID-19

NCT04399603 | Recruiting

• 1 other identifier: 283783
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

In the United Kingdom, there are currently 138,000 confirmed patients with coronavirus, causing 18,738 deaths. Whilst the disease may be mild in the majority of patients, a significant proportion of patients require intensive care therapy and a ventilator due to lung injury. In addition to lung injury/failure (acute respiratory distress syndrome (ARDS)), around 50% of patients admitted to intensive care develop acute kidney injury (AKI) (requiring advanced support via haemofiltration) and multi-organ failure. It is unclear why patients suffering from COVID-19 develop such severe lung injury (requiring life support or ventilation) or indeed why patients develop other organ dysfunction such as kidney injury. The investigators hypothesis that this may due to an over-reaction of the immune system particularly in the lungs. This then results in the release of various mediators and biological messengers which can be pushed into the blood bloodstream (exacerbated by positive pressure generated by the ventilator). These mediators then travel, via the blood, to other organs such as the kidney where they cause inflammation and injury of cells, resulting in organ failure. The investigators would like to apply their well-established laboratory methods to further the scientific community's knowledge of this severe and deadly viral condition and we hope that this would lead to the development of medication that would treat this deadly virus.

Conditions

COVID

Outcome Measures

Primary Outcomes (3)

• Variation in inflammatory mediators in patients with multi-organ failure suffering from COVID-19

  This will involve measurement of microvesicles in blood (numbers of MVs per µL)

  18 months

• Variation in inflammatory mediators in patients with multi-organ failure suffering from COVID-19

  This will involve measurement of microvesicles in bronchoalveolar lavage fluid (numbers of MVs per µL)

  18 months

• Variation in inflammatory mediators in patients with multi-organ failure suffering from COVID-19

  This will involve measurement of microvesicles in urine (numbers of MVs per µL)

  18 months

Secondary Outcomes (3)

• Correlation of inflammatory mediators in the bronchoalveolar lavage fluid with extent of lung injury (e.g. based upon oxygen requirement)

  18 months

• Correlation of circulating inflammatory mediators with renal and cardiovascular markers

  18 months

• Assess the role of inflammatory mediators obtained from patients in the development of renal injury using in vitro

  18 months

Study Arms (2)

COVID critically unwell patients

Non-Covid critically unwell Patietns

Other: no intervention-mechanistic study

Interventions

no intervention-mechanistic study OTHER

no intervention-mechanistic study

Non-Covid critically unwell Patietns

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Critically unwell patients requiring organ support

You may qualify if:

• Male and female patients aged 18-90 years;
• Patients diagnosed with COVID-19 and without COVID-19 (control purposes);
• Patients who have developed evidence of organ injury failure (requiring oxygen).

You may not qualify if:

• Patients who are under the age of 18;
• Refusal to consent/gain assent;
• Presence of an advanced directive to withhold or to withdraw life-sustaining treatment;
• Moribund patient likely to die within 24 hours.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Chelsea and Westminster Hospital NHS Foundation Trust

London, United Kingdom

RECRUITING

Imperial College NHS Trust

London, United Kingdom

RECRUITING

Study Design

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

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: May 22, 2020
• Study Start: June 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)