Inhalation of Low Molecular Weight Heparins as a prophylaxis to prevent SARS-CoV-2 infection

Inhalation of Low Molecular Weight Heparins as a prophylaxis to prevent SARS-CoV-2 infection - Nose-LMWH against COVID-19

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON50776

Enrollment

Registered

2020-11-20

Start date

2021-01-07

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

corona virus infection COVID-19

Interventions

370µL enoxaparin solution (Clexane Forte 150mg/ml) and saline (0.9%NaCl) applied with the MAD Nasal* Intranasal Mucosal Atomization Device will be administered in the left and right nasal cavity res

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy men and women between ages 18-65 with no medical history of immunodeficiencies or chronic illness.

Exclusion criteria

Exclusion criteria: COVID-19 in the volunteers medical history.

Design outcomes

Primary

Measure	Time frame
Primary endpoint: SARS-CoV-2 binding to the isolated cells will be measured by the SARS-CoV-2 binding assay to obtain a proof of concept that in vivo application of LMWH block virus binding. The amount of total virus bound to epithelial cells will be measured in pg/ml.	—

Secondary

Measure	Time frame
Secondary endpoint: Descriptive characterisation of immune activation of epithelial cells. Isolated epithelial cells will be stained for specific activation markers and cytokine in supernatant after culture will be measured. We do not expect any changes in activation markers/cytokines between the LMWH treated and saline treated group. Extension of the study (May 2021): Secondary endpoint: In addition to measuring binding using a pseudotyped virus (our primary endpoint), binding using the SARS-CoV-2 wildtype (WT) will be performed. This will be done to observe a truer virusbinding and block than can be achieved using the pseudotyped virus (as it*s a modified virus). Furthermore, given the large variability in obtained cells per volunteer, priority will be given to virusbinding using the pseudotyped virus, after which priority will fall to the wild type virus. Remaining cells will be stained for phenotyping, presence of ACE-2 and heparansulfates. After which activation markers will be observed.	—

Measure

Time frame

Secondary endpoint: Descriptive characterisation of immune activation of epithelial cells. Isolated epithelial cells will be stained for specific activation markers and cytokine in supernatant after culture will be measured. We do not expect any changes in activation markers/cytokines between the LMWH treated and saline treated group. Extension of the study (May 2021): Secondary endpoint: In addition to measuring binding using a pseudotyped virus (our primary endpoint), binding using the SARS-CoV-2 wildtype (WT) will be performed. This will be done to observe a truer virusbinding and block than can be achieved using the pseudotyped virus (as it*s a modified virus). Furthermore, given the large variability in obtained cells per volunteer, priority will be given to virusbinding using the pseudotyped virus, after which priority will fall to the wild type virus. Remaining cells will be stained for phenotyping, presence of ACE-2 and heparansulfates. After which activation markers will be observed.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)