Lanadelumab for Treatment of COVID-19 Disease (COVID_LAN)

Radboud University Medical Center

Status and phase: Completed; Phase 2; Phase 1

Conditions: COVID-19

Treatments: Other: regular care; Biological: lanadelumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04422509

UMCN-AKF20.04

Details and patient eligibility

About

So far little is very few drugs have demonstrated positive results for treatment of COVID19.

Recently the researchers have shown that the use of icatibant in COVID-19 results in a potent decrease in oxygen use. Yet the effect of the three dosages as according to the label dose was insufficient to maintain the clinical improvement in a small group of patients. The researchers argue that with the use of lanadelumab a more lasting effect can be reached due to its longer half life.

Enrollment: 43 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is SARS-COV2 positive (PCR)
• Without oxygen a saturation below 90%
• At least 3L/min oxygen dependent
• Patient is 16 years and older

Exclusion criteria

• Has previously participated in this study
• Acute myocardial or cerebral ischemic event at time of enrolment
• Receiving ACE or ARB inhibitor or comparable drugs that is specified as an intervention in this domain as a usual medication prior to this hospitalization will exclude a patient from receiving that agent
• A baseline alanine aminotransferase or an aspartate aminotransferase that is more than five times the upper limit of normal
• Patient is known hypersensitive to full human monoclonal antibodies
• Patient is pregnant or breast feeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

43 participants in 2 patient groups

lanadelumab

Experimental group

Description:

20 Patients will receive an intravenous dose of 300 mg lanadelumab on day 1, followed by a second dose of lanadelumab 300mg iv on day 4 (if needed).

Treatment:

Biological: lanadelumab

controls

Other group

Description:

20 patients will received standard of care In additiona, for every index patient we will match one historical controls. Controls will be matched based on age, bodyweight and gender.

Treatment:

Other: regular care