COVID-19
Conditions
Interventions
Intervention medication: 4500IE enoxaparin (in 300uL solution)
Control medication: NaCl 0,9% (in 300uL water)
Sponsors
ZonMW
Eligibility
Inclusion criteria
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
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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%). Pseudovirus binding was detected by p24 ELISA whereas authentic SARS-CoV-2 binding was detected by RT-PCR measurement of ORF1b/GAPDH. 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
| Measure | Time frame |
|---|---|
| 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. Timepoints: Phenotyping happens the same day that cells are obtained from study participants to ensure maximum viability of cells. | — |
Contacts
Public ContactKillian Vlaming
Academic Medical Centre Amsterdam
Outcome results
None listed