The investigators are investigating the tolerability of Heparin Sodium (porcine) administered
topically via a nasal spray. This agent is being investigated as a potential prophylactic
treatment to prevent infection by SARS(severe acute respiratory syndrome)-CoV-2, the novel
coronavirus that causes COVID-19. Heparin Sodium (porcine) is an FDA-approved anticoagulant
drug administered by injection. Recent work from multiple groups have found that heparin can
prevent the infection of cells by SARS-CoV-2, indicating a possible use as a topical
anti-viral. Numerous studies in both rodent models and humans have shown that heparin
administered via a pulmonary or intranasal route enters the blood stream in negligible
amounts, suggesting intranasal administration of heparin should be safe even at very large
doses. Data from mouse models indicate that repeated daily nasal administration of heparin
had no adverse effects in mice over a two week period (including weight loss, nose bleeds,
loss of sense of smell, nasal discharge, or decreased blood clotting time). However, no data
of repeated nasal administration of heparin in humans is available.
The investigators will test nasal administration of FDA-approved heparin sodium (porcine),
originally formulated for injection. The formulations the investigators will be testing
consist of heparin, sodium chloride, and 1% benzyl alcohol as a preservative bottled in a
nasal sprayer dispensing 0.1 mL(millilitres) per spray. The investigation is planned in two
phases. A single-dose phase will test the acute tolerability of the drug. In this phase,
subjects will be administered 0.1 mL of Heparin Sodium in each nostril formulated at one of
two doses: Day 1 will test a formulation of 5000 U(units)/mL, and Day 2 will test a
formulation of 10000 U(units) /mL. After each dose, subjects will be tested for systemic
exposure via blood aPTT tests and platelet count, as well as for local topical toxicity via
examination for epistaxis and anosmia, along with any other adverse events. In the chronic
phase, subjects will be administered the highest dose that was tolerated in the acute phase
daily for fourteen days. Subjects will be tested for aPTT and platelet count, as well as
epistaxis, anosmia and any other adverse events.