Covid19Early Phase 1NCT04490239
Intranasal Heparin Tolerability Study
A Early Phase 1 study testing Intranasal heparin sodium (porcine) in people with Covid19, run by Joshua Sharp at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Intranasal heparin sodium (porcine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2020to 18 Nov 2020
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Normal, healthy adults aged 18 to 65 years
Who cannot join
- Allergy to Heparin
- Currently taking any prescription blood thinners or anti-coagulants, or currently taking any intranasal medication
- Known history of anemia, thrombocytopenia, or other blood disorder
- Autoimmune disorders
- Known history of Neurologic/Psychiatric disorders
- Report of an active infection
- Subject is pregnant or breast-feeding, or is expecting to conceive during the study.
- NOTE: Subjects will be instructed to abstain from alcohol for the duration of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Mississippi National Center for Natural Products Research
University, Mississippi, 38677-1848
About this study
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.
Read the detailed description
Study Objectives
This exploratory clinical trial is designed to assess tolerability of increasing doses of intranasally administered heparin sodium in saline solution. Baseline values for aPTT and complete blood count will be obtained from six subjects. Heparin will be administered in increasing concentrations using one 0.1 mL(millilitre) spray per nostril (0.2 ml total) on a daily basis. Major signs of toxicity will be clinically relevant changes in aPTT time, clinically relevant decrease in platelet count, signs of anosmia 30 minutes after administration, or epistaxis. Dosing will start at 1000 units of heparin administered (500 units in each nostril) and then escalated to 2000 units. Should a clinically relevant aPTT prolongation (>50% increase from subject baseline) or decrease in platelet count (below clinical lab normal limit) be observed at either dose, the study will be halted and a series of lower doses evaluated.
Study Overview
Description of Design of Study
This study is a single center, prospective, Phase 0 exploratory tolerability trial. A total of 6 healthy subjects (3 M and 3 F) will be enrolled into the study. This study will evaluate the acute and multi-day (14 days) tolerability of intranasally administered heparin.
Test Article
Investigational Product
The study will assess the single and multi-dose tolerability of intranasal administration of an aliquot of an FDA-approved heparin sodium injection (5,000 USP units/mL or 10,000 USP units/mL) to deliver 1000U (units) or 2000U of heparin sodium. Doses will be prepared and administered as follows:
1000 U = (2 x 0.1 mL(milliliter) of 5000U(units)/mL or one spray of 500 U in each nostril) 2000 U = (2 x 0.1 mL of 10000U/mL or one spray of 1000 U in each nostril)
The test article will be administered by transferring (4 mL) of sterile heparin sodium injection (5,000 USP units/mL or 10,000 USP units/mL) at ambient room temperature into intranasal spray bottles, one for each individual subject.
The test article will be administered within 4 weeks of preparation, and the remainder discarded after study completion.
Supplier The test article (Heparin Sodium USP) will be obtained from appropriate commercial sources.
Safety Assessments
Safety assessments will be completed as part of this single and multi-dose, pharmacokinetic study. Safety will be assessed prior to test article administration and at 24 post dose, in the acute phase. For safety assessments during the chronic phase, safety assessments will be assessed prior to test article administration , day 14 and day 15-post study. Test subject will be called every three (3) days for updates and subjective reports (adverse events), during 14 day, daily dose phase. Subject safety will be assessed by monitoring adverse events, clinical laboratory tests, vital signs, and physical examinations.
Laboratory parameters will be evaluated during screening and daily, to include the following:
- Complete Blood Count (WBC, RBC(red blood cell count), Hematocrit, Hemoglobin, MCV (mean corpuscular volume), Platelet Count)
- PT(prothrombin time)/INR (international normalized ratio) Baseline and post study
- Serum/Urine hCG ( human chorionic gonadotropin)baseline and predose
- Activated Partial Thromboplastin Time (aPTT)
Clinical Adverse Events
Clinical Adverse Events will be monitored throughout the study. However, such events are not anticipated during this trial due to the low systemic exposure of the test article being administered. However, local side effects of intranasal heparin, such as epistaxis or nasal congestion may result.
For any abnormal lab values, test subjects will be evaluated for any sign and symptoms, and labs will be redrawn, until stabilized or returned to baseline. Subjects will be referred to the primary physician for any continued care required.
- Conditions
- Covid19
- Being tested
- Intranasal heparin sodium (porcine)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal heparin sodium (porcine)Drug
Also called NDC (National Drug Code) 0409-2721-30, NDC 0409-2723-01
Intranasal heparin sodium
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL.
Acute phase:
On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects.
Chronic phase:
The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records. Receives: Drug: Intranasal heparin sodium (porcine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 1000 U intranasal dose of heparin
Measured: 24 hours after a 1000 U intranasal dose of heparin
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 2000 U intranasal dose of heparin
Measured: 24 hours after 2000 U dose intranasal heparin
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained immediately after the 14 consecutive day of daily 2000 U dose of intranasal heparin
Measured: Day 14, chronic phase
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained 24 hours after the 14 consecutive day of daily 2000 U dose of intranasal heparin
Measured: 24 hours after the last 2000 U dose of the chronic phase
Percent Change in Platelet Count From Pre-dose Baseline
Indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase.
Measured: Pre-dose baseline, Day 14 chronic phase
Number of Incidents of Epistaxis, Acute Phase
Number of incidents of blood coming from the nose during the acute phase
Measured: Day 0 through Day 2, acute phase
Number of Incidents of Epistaxis, Chronic Phase
Blood coming from the nose or pink tinged nasal secretions
Measured: Day 1 through Day 15, chronic phase
Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14
Abnormally low platelet counts indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase.
Measured: Day 14, Chronic Phase
Secondary outcomes (2)
Other Adverse Effects, Acute Phase
Reports of mild, short-lived nasal irritation immediately after administration including mild burning sensation
Measured: Day 0 through Day 2, acute phase
Other Adverse Effects, Chronic Phase
Reports of mild, short-lived nasal irritation immediately after administration including mild burning sensation, itchiness or sneezing
Measured: Day 1 through Day 15, chronic phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start9 Oct 2020
- Primary completion18 Nov 2020
- Study completion18 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- This study will evaluate the acute and multi-day (14 days) tolerability of intranasally administered heparin. Two doses will be tested in the acute phase: 1000 U/day, then 2000 U/day. In the multi-day phase, the highest tolerated dose from the acute phase will be tested over a 14-day period of daily self-administration.
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Sharp
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Sharp, University of Mississippi, Oxford
- Investigators
- Bill Gurley, PhD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04490239
- Sponsor's protocol ID
- Intranasal Heparin
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2020
- Last updated
- 30 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported, after deidentification
Publications
Tandon R, Sharp JS, Zhang F, Pomin VH, Ashpole NM, Mitra D, Jin W, Liu H, Sharma P, Linhardt RJ. Effective Inhibition of SARS-CoV-2 Entry by Heparin and Enoxaparin Derivatives. bioRxiv [Preprint]. 2020 Jul 28:2020.06.08.140236. doi: 10.1101/2020.06.08.140236.
PubMed 32577638
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Heparin Tolerability Study
- ClinicalTrials.gov ID
- NCT04490239
- Acronym / sponsor ID
- Intranasal Heparin
- Conditions
- Covid19
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Joshua SharpUniversity, hospital or other
- Study start
- 9 Oct 2020 (actual)
- Primary completion
- 18 Nov 2020 (actual)
- Study completion
- 18 Nov 2020 (actual)
- First posted
- 29 Jul 2020 (actual)
- Results
- Posted 28 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study Objectives
This exploratory clinical trial is designed to assess tolerability of increasing doses of intranasally administered heparin sodium in saline solution. Baseline values for aPTT and complete blood count will be obtained from six subjects. Heparin will be administered in increasing concentrations using one 0.1 mL(millilitre) spray per nostril (0.2 ml total) on a daily basis. Major signs of toxicity will be clinically relevant changes in aPTT time, clinically relevant decrease in platelet count, signs of anosmia 30 minutes after administration, or epistaxis. Dosing will start at 1000 units of heparin administered (500 units in each nostril) and then escalated to 2000 units. Should a clinically relevant aPTT prolongation (>50% increase from subject baseline) or decrease in platelet count (below clinical lab normal limit) be observed at either dose, the study will be halted and a series of lower doses evaluated.
Study Overview
Description of Design of Study
This study is a single center, prospective, Phase 0 exploratory tolerability trial. A total of 6 healthy subjects (3 M and 3 F) will be enrolled into the study. This study will evaluate the acute and multi-day (14 days) tolerability of intranasally administered heparin.
Test Article
Investigational Product
The study will assess the single and multi-dose tolerability of intranasal administration of an aliquot of an FDA-approved heparin sodium injection (5,000 USP units/mL or 10,000 USP units/mL) to deliver 1000U (units) or 2000U of heparin sodium. Doses will be prepared and administered as follows:
1000 U = (2 x 0.1 mL(milliliter) of 5000U(units)/mL or one spray of 500 U in each nostril) 2000 U = (2 x 0.1 mL of 10000U/mL or one spray of 1000 U in each nostril)
The test article will be administered by transferring (4 mL) of sterile heparin sodium injection (5,000 USP units/mL or 10,000 USP units/mL) at ambient room temperature into intranasal spray bottles, one for each individual subject.
The test article will be administered within 4 weeks of preparation, and the remainder discarded after study completion.
Supplier The test article (Heparin Sodium USP) will be obtained from appropriate commercial sources.
Safety Assessments
Safety assessments will be completed as part of this single and multi-dose, pharmacokinetic study. Safety will be assessed prior to test article administration and at 24 post dose, in the acute phase. For safety assessments during the chronic phase, safety assessments will be assessed prior to test article administration , day 14 and day 15-post study. Test subject will be called every three (3) days for updates and subjective reports (adverse events), during 14 day, daily dose phase. Subject safety will be assessed by monitoring adverse events, clinical laboratory tests, vital signs, and physical examinations.
Laboratory parameters will be evaluated during screening and daily, to include the following:
- Complete Blood Count (WBC, RBC(red blood cell count), Hematocrit, Hemoglobin, MCV (mean corpuscular volume), Platelet Count)
- PT(prothrombin time)/INR (international normalized ratio) Baseline and post study
- Serum/Urine hCG ( human chorionic gonadotropin)baseline and predose
- Activated Partial Thromboplastin Time (aPTT)
Clinical Adverse Events
Clinical Adverse Events will be monitored throughout the study. However, such events are not anticipated during this trial due to the low systemic exposure of the test article being administered. However, local side effects of intranasal heparin, such as epistaxis or nasal congestion may result.
For any abnormal lab values, test subjects will be evaluated for any sign and symptoms, and labs will be redrawn, until stabilized or returned to baseline. Subjects will be referred to the primary physician for any continued care required.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study will evaluate the acute and multi-day (14 days) tolerability of intranasally administered heparin. Two doses will be tested in the acute phase: 1000 U/day, then 2000 U/day. In the multi-day phase, the highest tolerated dose from the acute phase will be tested over a 14-day period of daily self-administration.
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Intranasal heparin sodium (porcine)Subjects will be administered heparin sodium (porcine) bottled in a nasal sprayer with a volume per spray of 0.1 mL. Acute phase: On day 1, each subject will be administered 0.1 mL per nostril of 5000 U/mL heparin sodium (porcine), for a total dose of 1000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects. On day 2, each subject will be administered 0.1 mL per nostril of 10000 U/mL heparin sodium (porcine), for a total dose of 2000 U. Vital signs, blood work, and follow-up clinical observation will be used to detect adverse effects. Chronic phase: The highest acute dose that has no impact on aPTT or INR will be used for the chronic phase of this study. Each subject will be administered a daily dose for fourteen days. The first and last dose will be administered in the clinic; all other doses will be self-administered by subjects at home at the same time of day using a dosing diary to keep records. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Normal, healthy adults aged 18 to 65 years
Key exclusion criteria (8 listed)
- Allergy to Heparin
- Currently taking any prescription blood thinners or anti-coagulants, or currently taking any intranasal medication
- Known history of anemia, thrombocytopenia, or other blood disorder
- Autoimmune disorders
- Known history of Neurologic/Psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal heparin sodium (porcine)Also: NDC (National Drug Code) 0409-2721-30, NDC 0409-2723-01Intranasal heparin sodium | Drug | Experimental Arm |
Primary outcome
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1
Time frame: 24 hours after a 1000 U intranasal dose of heparin
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 1000 U intranasal dose of heparin
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 2
Time frame: 24 hours after 2000 U dose intranasal heparin
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin collected 24 hours after a 2000 U intranasal dose of heparin
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 14
Time frame: Day 14, chronic phase
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained immediately after the 14 consecutive day of daily 2000 U dose of intranasal heparin
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Chronic Phase Day 15
Time frame: 24 hours after the last 2000 U dose of the chronic phase
A measurement of blood clotting ability; tests for systemic bioavailability of intranasal heparin obtained 24 hours after the 14 consecutive day of daily 2000 U dose of intranasal heparin
Percent Change in Platelet Count From Pre-dose Baseline
Time frame: Pre-dose baseline, Day 14 chronic phase
Indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase.
Number of Incidents of Epistaxis, Acute Phase
Time frame: Day 0 through Day 2, acute phase
Number of incidents of blood coming from the nose during the acute phase
Number of Incidents of Epistaxis, Chronic Phase
Time frame: Day 1 through Day 15, chronic phase
Blood coming from the nose or pink tinged nasal secretions
Number of Participants With Normal or Abnormal Platelet Counts, Chronic Phase Day 14
Time frame: Day 14, Chronic Phase
Abnormally low platelet counts indicative of heparin-induced thrombocytopenia, a serious adverse side effect of systemically bioavailable heparin, measured immediately after the last 2000 U intranasal dose of the chronic phase.
2 secondary outcomes
Other Adverse Effects, Acute Phase
Time frame: Day 0 through Day 2, acute phase
Other Adverse Effects, Chronic Phase
Time frame: Day 1 through Day 15, chronic phase
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32577638Tandon R, Sharp JS, Zhang F, Pomin VH, Ashpole NM, Mitra D, Jin W, Liu H, Sharma P, Linhardt RJ. Effective Inhibition of SARS-CoV-2 Entry by Heparin and Enoxaparin Derivatives. bioRxiv [Preprint]. 2020 Jul 28:2020.06.08.140236. doi: 10.1101/2020.06.08.140236.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bill Gurley, PhD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Intranasal heparin sodium (porcine) in people with Covid19, run by Joshua Sharp at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Normal or Abnormal Activated Partial Thromboplastin Time (aPTT), Acute Phase Day 1 (time frame: 24 hours after a 1000 U intranasal dose of heparin). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04490239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021; AzTrials last refreshed its copy on 30 Oct 2026.