Intranasal LMWH against COVID-19

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 34

Inclusion Criteria

In order to be eligible for participation, a participant must:
- be able to provide written informed consent (Verbal informed consent or deferred informed concent will be used for the initial screening visit, where written informed consent will be obtained).
- be physically healthy (as defined by not suffering from any illness or disease obstructing general daily functioning)
- be aged between 18 – 65 years
- be sufficiently well versed in the Dutch language, subject to the opinion of the Investigator

Exclusion Criteria

If any of the following apply to someone wishing to participate, he/she is rendered ineligible for participation, a participant:
- is unlikely to comply with study procedures, as deemed by the recruiting research doctor/nurse
- has mental disorders that in the view of the investigator would interfere with adherence to study procedures or might impair a decision to participate in the study
- has a known allergy or intolerance to LWWH or heparine-related products, as well as a medical history of heparine inducted thrombocytopenia (HIT).
- has any relevant clinical medical condition that is in the opinion of the investigator to make a volunteer unsuitable for participation in the study (under which underlying haematological disorders or bleeding disorder.
- has (anamnestic) evidence of a respiratory infection in the 4 weeks prior to enrolment.
- has a tympanic temperature exceeding 38,5 degrees Celsius during the screening and clinical visits.
- has frequent nosebleeds (>1/ month).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary endpoints: We investigated whether inhalation of enoxaparin by human study participants blocks binding of SARS-CoV-2 to human nasal epithelial cells. Binding of both SARS-CoV-2 pseudovirus (pg/mL) and the authentic virus, hCoV-19/Italy (TCID/ml) to nasal epithelial cells obtained from volunteers after their nasal cavity was exposed to either LMWH enoxaparin or placebo (saline NaCl 0,9%). <br>Pseudovirus binding was detected by p24 ELISA whereas authentic SARS-CoV-2 binding was detected by RT-PCR measurement of ORF1b/GAPDH. <br><br>Timepoints: Virusbinding happens on the same day as cells are obtained from study participants to ensure maximum viability of cells, virus exposure happens for 4 hours at 4C after which all cells are lysed to prevent further infection.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints: We characterized the nasal cell populations and the effect on inhalation on lymphocyte influx, as well as on expression of ACE-2 and heparan sulfates. We investigated the effectiveness of inhalation of enoxaparin by comparing inhalation with in vitro addition of enoxaparin prior to SARS-CoV-2 binding.<br><br>Timepoints: Phenotyping happens the same day that cells are obtained from study participants to ensure maximum viability of cells.