Antisense Therapy to Block the Kallikrein-kinin Pathway in COVID-19
Status:
Active, not recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
Up to 1/3 of all patients infected with COVID-19 can develop complications that require
hospitalization. Severe pneumonia associated with acute respiratory distress syndrome (ARDS)
is the most threatening and feared complication of COVID-19 infection, with mortality rates
close to 50% in some groups.
Autopsies between these severe cases reveal severe capillary involvement, with signs of
intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal
tissue repair. The available evidence suggests that abnormal activation or imbalance in the
counter-regulation of the kallikrein-kinin system may play a central role in a positive
feedback cycle, leading to consequent diffuse microangiopathy. Blockade of the
kallikrein-kinin system can therefore prevent deterioration of lung function by reducing
inflammation, edema and microthrombosis.
The objective of this phase IIb study is to assess the preliminary effects on the oxygenation
parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients
with moderate to severe COVID-19.
Phase:
Phase 2
Details
Lead Sponsor:
Hospital do Coracao
Collaborators:
Hospital Moinhos de Vento Ionis Pharmaceuticals, Inc.