Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.04 |
| D018352 | Coronavirus Infections NIH | 0.04 |
| Name (Synonyms) | Correlation |
|---|
Navigate: Correlations HPO
There is one clinical trial.
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.
Description: A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin
Measure: activated partial thromboplastin time (aPTT), acute phase Time: Day 0 through Day 2, acute phaseDescription: A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin
Measure: activated partial thromboplastin time (aPTT), chronic phase Time: Day 1 through Day 15, chronic phaseDescription: Indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin
Measure: platelet count, acute phase Time: Day 0 through Day 2, acute phaseDescription: Indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin
Measure: platelet count, chronic phase Time: Day 1 through Day 15, chronic phaseDescription: Blood coming from the nose
Measure: Number of incidents of epistaxis, acute phase Time: Day 0 through Day 2, acute phaseDescription: Blood coming from the nose
Measure: Number of incidents of epistaxis, chronic phase Time: Day 1 through Day 15, chronic phaseDescription: Other non-specified adverse effects observed in the clinic or self-reported
Measure: Other adverse effects, acute phase Time: Day 0 through Day 2, acute phaseDescription: Other non-specified adverse effects observed in the clinic or self-reported
Measure: Other adverse effects, chronic phase Time: Day 1 through Day 15, chronic phaseAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports