COVID-19Phase 1/2COVID_LANNCT04422509
Lanadelumab for Treatment of COVID-19 Disease
A Phase 1/2 study testing lanadelumab and regular care in people with COVID-19, run by Radboud University Medical Center at 4 sites in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- lanadelumab and regular care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 4 sitesNetherlands
- Study dates
- 30 Oct 2020to 30 Apr 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient is SARS-COV2 positive (PCR)
- Without oxygen a saturation below 90%
- At least 3L/min oxygen dependent
- Patient is 16 years and older
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
Netherlands4 sites
Amsterdam UMC
Amsterdam
Rijnstate hospital
Arnhem
Radboudumc
Nijmegen
UMC Utrecht
Utrecht
About this study
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.
- Conditions
- COVID-19
- Being tested
- lanadelumab, regular care
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lanadelumabBiological
single dose, or two doses administered iv
regular careOther
no lanadelumab administration, treated according to regular care
| Study group | Role | What they receive |
|---|---|---|
| lanadelumab | Experimental | 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). Receives: Biological: lanadelumab |
| controls | Other | 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. Receives: Other: regular care |
What is being measured
The primary outcome is the main question the study is designed to answer.
oxygen
oxygen use in L/min
Measured: 2 weeks
Secondary outcomes (1)
adverse events
adverse events after lanadelumab administration
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start30 Oct 2020
- Primary completion25 Feb 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controls will get standard of care and historical controls will be matched to the patients included
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04422509
- Sponsor's protocol ID
- UMCN-AKF20.04
- Acronym
- COVID_LAN
- Status last verified
- Jul 2021
- First submitted
- 3 Jun 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: this has not yet been decided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lanadelumab for Treatment of COVID-19 Disease
- ClinicalTrials.gov ID
- NCT04422509
- Acronym / sponsor ID
- COVID_LAN / UMCN-AKF20.04
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- controls will get standard of care and historical controls will be matched to the patients included
| Arm | Type | Receives |
|---|---|---|
| lanadelumab | Experimental | Biological: lanadelumab20 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). |
| controls | Other | Other: regular care20 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patient is SARS-COV2 positive (PCR)
- Without oxygen a saturation below 90%
- At least 3L/min oxygen dependent
- Patient is 16 years and older
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lanadelumabsingle dose, or two doses administered iv | Biological | lanadelumab |
| regular careno lanadelumab administration, treated according to regular care | Other | controls |
Primary outcome
oxygen
Time frame: 2 weeks
oxygen use in L/min
1 secondary outcome
adverse events
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: Undecided. this has not yet been decided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lanadelumab and regular care in people with COVID-19, run by Radboud University Medical Center at 4 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxygen (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.