Inhibition of Bradykinin in COVID-19 Infection With Icatibant

NCT05407597 | Completed Phase 2 DMC

• 2 other identifiers: 21036JK-AS2021-005851-35
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

SARS CoV 2 Infection

Keywords

Bradykinin; Alveolar-arterial gradient; Interleukin-6 (IL-6)

Outcome Measures

Primary Outcomes (1)

• Change in Oxygenation

  Alveolar-arterial gradient (Arterial blood gas sampling and FIO2 measurement)

  Baseline and 3 hours after study drug administration

Secondary Outcomes (3)

• Change in Blood pressure

  Baseline and 3 hours after study drug administration

• Change in mean arterial pressure (MAP)

  Baseline and 3 hours after study drug administration

• Change in heart rate

  Baseline and 3 hours after study drug administration

Other Outcomes (3)

• Change in interleukin-6 levels

  Baseline and 3 hours after study drug administration

• Change in retinal vessel size (As measured by optical coherence tomography)

  Baseline and 3 hours after study drug administration

• Oxygen requirements and saturations 24 hours post study drug

  Approximately 24 hours after study drug administration

Study Arms (2)

Icatibant and Standard of care (SOC)

ACTIVE COMPARATOR

Icatibant will be given as a single, subcutaneous injection

Drug: Icatibant

0.9% Sodium Chloride and Standard of care (SOC)

PLACEBO COMPARATOR

Placebo will be given as a single, subcutaneous injection

Drug: 0.9% Sodium Chloride Injection

Interventions

Icatibant DRUG

Solution for injection, 30mg (3mls) administered as a single subcutaneous injection SARS CoV-2 patients will receive all supportive treatment and medications that are used as standard of care including but not limited to Dexamethasone, Remdesivir, Tocilizumab and antibiotics.

Icatibant and Standard of care (SOC)

0.9% Sodium Chloride Injection DRUG

Solution for injection (3mls) administered as a single subcutaneous injection SARS CoV-2 patients will receive all supportive treatment and medications that are used as standard of care including but not limited to Dexamethasone, Remdesivir, Tocilizumab and antibiotics.

0.9% Sodium Chloride and Standard of care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years.
• Documented evidence of COVID-19 and symptom onset of 7 days or less
• Acute hypoxia which will be defined as either low resting saturations \<94% or supplementary oxygen to maintain oxygen saturations at \>94%

You may not qualify if:

• Patients known to be pregnant or breastfeeding.
• Patients with unstable ischaemic heart disease or acute stroke
• Patients enrolled in other clinical trials of an investigational medicine within the previous 28 day period
• Patients who refuse to have blood samples taken.
• Known hypersensitivity to Icatibant
• 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).
• Patients with chronic heart or lung disease whose oxygen levels are reduced, but are unchanged from baseline

Sponsors & Collaborators

• Belfast Health and Social Care Trust: lead
• Queen's University, Belfast: collaborator

Study Sites (1)

Mater Infirmorum Hospital

Belfast, Antrim, BT14 6AB, United Kingdom

Location

Related Publications (1)

• Bailey M, Linden D, Earley O, Guo Parke H, McAuley DF, Peto T, Taggart C, Kidney J. Inhibition of bradykinin in SARS-CoV-2 infection: a randomised, double-blind trial of icatibant compared with placebo (ICASARS). BMJ Open. 2023 Nov 30;13(11):e074726. doi: 10.1136/bmjopen-2023-074726.

  PMID: 38035747 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

icatibant; Sodium Chloride

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Joe Kidney, MD

  Belfast Health and Social Care Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Patients and investigators will be blinded to treatment allocation. An unblinded research nurse will administer the study medication.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomly allocated to receive either Icatibant (30mg) or 0.9% Sodium Chloride (3mls)

Study Record Dates

• First Submitted: May 11, 2022
• First Posted: June 7, 2022
• Study Start: May 16, 2022
• Primary Completion: June 9, 2023
• Study Completion: July 7, 2023
• Last Updated: September 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)