Inhibition of Bradykinin in COVID-19 Infection With Icatibant

• Status: Recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

There is excess accumulation of bradykinin during symptomatic SARS CoV-2 lung infection. Bradykinin causes oedema in the lung, with reduced oxygen. It also causes vasodilation, hypotension and cytokine release.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Belfast Health and Social Care Trust
• Collaborator: Queen's University, Belfast
• Treatments: Icatibant

Criteria

Inclusion Criteria:

1. Age >18 years.

2. Documented evidence of COVID-19 and symptom onset of 7 days or less

3. Acute hypoxia which will be defined as either low resting saturations <94% or supplementary oxygen to maintain oxygen saturations at >94%

Exclusion Criteria:

1. Patients known to be pregnant or breastfeeding.

2. Patients with unstable ischaemic heart disease or acute stroke

3. Patients enrolled in other clinical trials of an investigational medicine within the previous 28 day period

4. Patients who refuse to have blood samples taken.

5. Known hypersensitivity to Icatibant

6. Patients who at time of consent are likely to require imminent non-invasive/ invasive ventilatory support or patients already established on continuous positive airway pressure (CPAP).

7. Patients with chronic heart or lung disease whose oxygen levels are reduced, but are unchanged from baseline