Covid19Phase 1/2EnHanCedNCT04743011

Enriched Heparin Anti COVID-19 Trial

A Phase 1/2 study testing Heparin sodium in people with Covid19, run by UPECLIN HC FM Botucatu Unesp at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Covid19
What is being tested?: Heparin sodium
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 2 sitesBrazil
Study dates: 1 Jun 2021to 31 Dec 2021
Phase: Phase 1/2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Signature and agreement to the Free Consent Form;
Both sexes, of any ethnic origin, aged between 18 and 90 years;
COVID-19 infected patients diagnosed by RT-PCR (reverse-transcriptase polymerase chain reaction) or with a strong suspicion of COVID-19 by clinical evaluation through compatible clinical and radiological findings;
Time of disease evolution less than 10 days;
Radiological diagnosis of grade 2A pneumonia, with gas exchange ratio > 200 on blood gas analysis (paO2 / pFiO2), characterizing mild hypoxemia;
Indication of hospital treatment regime, provided that the period of hospitalization before inclusion is not more than 24 hours;
Need for supplemental oxygen therapy (O2) less than 5L / min.

Who cannot join

No agreement to the terms of this study;
Moderate or severe respiratory failure requiring admission to the ICU and the need for invasive mechanical ventilation or non-invasive ventilation (NIV) with positive pressure;
Pregnancy or puerperium;
Patients with hematological diseases, coagulation disorders, use of anticoagulants, previous heparin-induced allergy or thrombocytopenia, thrombocytopenia with a count of fewer than 50,000 platelets / mm3;
COVID-19 not confirmed by RT-PCR within 72 hours of inclusion in the study.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites

School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil
Botucatu, São Paulo, 18607030
Hospital das Clinicas de Boucatu
Botucatu, São Paulo, 18618970

Other trials in Brazil

About this study

Official title: Nebulized Enriched Heparin to Treat no Critical Patients With Sars-Cov-2 - Triple Blind Clinical Trial

Coronavirus 19 (COVID-19) is a viral respiratory disease that was identified in December 2019 after the first cases in China, spreading rapidly until reaching pandemic status, causing the collapse of numerous health systems and strong economic and social impact. By the end of April 2020, 3.08 million cases, and more than 214 thousand deaths were already recorded. The treatment so far has not been established and there are several clinical trials testing known drugs that have antiviral activity in vitro, due to the urgency that the global situation imposes. Medicines with specific actions can take years to be discovered, while a vaccine also takes a long time. Recently, it has been shown that the worsening of Coronavirus infection may be related to the formation of micro clots in blood vessels and anticoagulants have been used as adjuvants in the treatment. This study is justified by conducting a pilot study that showed an in vitro antiviral action (anti-COVID-19) of high molecular weight heparin. Methods: A phase I / II clinical trial will be conducted. 40 participants will be included in two arms. Participants allocated to Group 1 (control) will receive inhalation with 0.9% saline applied 4/4 hours, for 7 days. Participants allocated to Group 2 (intervention) will receive high molecular weight inhaled heparin (250ug / mL 0.9% SF), at a 4/4 hour dose, for 7 days. The outcomes of interest will be safety (absence of moderate or serious adverse events) and effectiveness (measured in a score of 7 points, with 1 absence of limitations and 7, death). Expected results: The development of a new therapeutic option for COVID-19 is expected, with the possibility of use in other serious coronavirus diseases, to be subsequently tested in phase III studies.

Read the detailed description

In view of the enormous health, financial and social crisis resulting of the pandemic caused by SARS-Cov-2, it is justified to urgently conduct tests with possible antiviral drugs. The high molecular weight heparin (HMWH) (heparin enriched by ultrafiltration process) proposed by this study, has a potential inhibition activity over viral replication, demonstrated by preliminary in vitro tests, carried out in a model established in partnership with the Laboratory of Clinical and Molecular Virology (LVCM) of the Institute of Biomedical Sciences of the University of São Paulo (ICB-USP).

Along with the findings in the literature, such as the study carried out by Phelps, M.K. et al (2020), among others, the use of inhaled heparin presents adequate levels of safety to be used in a clinical trial. Taking into account that the dose of high molecular weight heparin (enriched by this study team) with antiviral activity in vitro is much lower than the doses currently presented in published clinical trials using inhaled UFH, we have the safety premise to carry out this study. The intentions of this study differ from what has been presented in the world literature so far, as it does not aim to induce anticoagulation, nor to effectively inhibit the formation of pulmonary fibrin, but rather, to act as an inhibitor of viral replication.

Also, as characteristics of the product to be tested, this heparin (HMWH) is presented in a buffered solution free of low-sulfated low-weight molecules, which is obtained in a sterile environment through ultrafiltration of the unfractionated solution of porcine origin available in Brazil (Hemofol - Cristália) using Centriprep-10kDa® centrifuge filter (Millipore ™) used as recommended by the manufacturer.

The high molecular weight heparin (HMWH) - enriched heparin - had two process patents filed, one under the description "HIGH MOLECULAR WEIGHT DEFINITION HEPARINE DEVELOPMENT PROCESS", BR 102014027804-4 A2 - granted by the Instituto Nacional de Propriedade Industrial (INPI) and another with the description "COMPOSITION OF HIGH MOLECULAR WEIGHT NON-FRACTIONAL HEPARINE FOR ANTIVIRAL ACTION ", BR 102020 011964-8 - deposited at INPI.

Conditions: Covid19
Being tested: Heparin sodium, Placebo
Keywords: COVID-19, Heparin, Antiviral Agents, Blood Coagulation, Clinical Protocols
Medical subject headings: COVID-19, Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Heparin sodiumDrug
Also called Hepamax S BLAU
Nebulized inhalation of 5 mL of a solution containing high molecular weight heparin - enriched heparin - 2.5mg/mL and 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)
PlaceboDrug
Also called Saline solution 0.9%, Physiological solution 0.9%
Nebulized inhalation of 5 mL of 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)

Study groups in NCT04743011
Study group	Role	What they receive
Placebo	Placebo comparator	Participants will receive inhalation with 5mL 0.9% saline solution (placebo), 4/4h, during the day period (5 doses). Receives: Drug: Placebo
Heparin sodium	Active comparator	Participants will receive inhalation with 5mL 0.9% saline solution + 2,5mg of high molecular weight heparin - enriched heparin, 4/4h, during the day period (5 doses). Receives: Drug: Heparin sodium

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Activated Partial Thromboplastin Time (APTT) > 1.5 Seconds
Safety-related to the use of high molecular weight heparin inhaled in patients with SARS-COV-2 through the assessment of hemorrhagic events of any nature, alteration of the coagulogram that indicates an APTT ratio > 1.5 or heparin-induced thrombocytopenia.
In Brazilian standards, the APTT is measured in seconds and compared to a laboratory control for a ratio, which is used as a measurement.
Measured: Immediately or up to 8 days after starting treatment
Number of Participants With a Negative Viral Load in Nasal Swab Reverse Transcription Polymerase Chain Reaction (RT-PCR).
Effectiveness related to the proposed treatment, based on the analysis of the viral load of SARS-COV-2 virus in the participants through a sequential assessment of the viral load in nasal swab RT-PCR.
The measurement consists in patients that tested negative for any viral load at the end of the treatment.
Measured: Immediately or up to 8 days after starting treatment

Secondary outcomes (8)

Number of Participants That Develop Renal Failure
Worsening of clinical parameters characterized by renal failure through measurement of urea and creatinine;
Measured: Immediately or up to 8 days after starting treatment
Number of Participants That Develop Major Cardiovascular Events
Worsening of clinical parameters characterized by major cardiovascular events (pulmonary embolism, acute myocardial infarction)
Measured: Immediately or up to 8 days after starting treatment
Number of Participants That Develop Deep Vein Thrombosis (DVT)
Worsening of clinical parameters characterized by deep vein thrombosis (DVT);
Measured: Immediately or up to 8 days after starting treatment
Number of Participants That Develop Pancreatitis
Worsening of clinical parameters characterized by pancreatitis through measurement of amylase (> 200 U/L);
Measured: Immediately or up to 8 days after starting treatment
Number of Deaths Among Participants
Worsening of clinical parameters characterized by death;
Measured: Immediately or up to 8 days after starting treatment
Number of Participants With Increased C Reactive Protein Test
Worsening of laboratory parameters measured by increase in C reactive protein test (>3.00mg/L);
Measured: Immediately or up to 8 days after starting treatment
Number of Participants With Deterioration of Arterial Blood Gas paO2/pFiO2 Ratio
Worsening of laboratory parameters measured by alterations in arterial blood gas measured by paO2/pFiO2 < 200;
Measured: Immediately or up to 8 days after starting treatment
Number of Participants With Increased Pulmonary Area Compromised (%)
Worsening of tomographic parameters measured by the pulmonary area compromised by the infection and/or inflammation.
Measured: Immediately or up to 8 days after starting treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 202131 Dec 2021

First posted8 Feb 2021
Study start1 Jun 2021
Primary completion30 Nov 2021
Study completion31 Dec 2021

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 (2)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: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants allocated to Group 1 (control) will receive inhalation with 0.9% saline solution applied 4/4 hours, for 7 days. Participants allocated to Group 2 (intervention) will receive high molecular weight inhaled heparin (2,5mg / mL 0.9% SF), at a 4/4 hour dose, for 7 days.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04743011
Sponsor's protocol ID: UPECLIN-MB-2
Acronym: EnHanCed
Status last verified: Oct 2024
First submitted: 3 Feb 2021
Last updated: 15 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: There is a plan to make IPD and related data dictionaries available

Publications

Phelps MK, Olson LM, Patel MAVB, Thompson MJ, Murphy CV. Nebulized Heparin for Adult Patients With Smoke Inhalation Injury: A Review of the Literature. J Pharm Technol. 2020 Aug;36(4):130-140. doi: 10.1177/8755122520925774. Epub 2020 Jun 1.
PubMed 34752548
Ramos da Silva Grillo VT, Bertanha M, da Silva Rodrigues L, de Lima MA, Mellucci Filho PL, Rahal Guaragna Machado R, Durigon EL, Dias Sertorio N, de Assis Golim M, Moroz A, Marques Braz AM, de Moraes LN, Leite MA, Bonciani Nader H, de Campos GC, Rodrigues Guzzo Carvalho C, Florenca Cardoso F, Magro AJ, Caputo Nunes H, Tommasini Grotto RM, de Cassia Alvarado R, de Moura Campos Pardini MI, Lima Sobreira M, da Costa EAPN, Naime Barbosa A, Fortaleza CMCB. Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial. Sci Rep. 2024 Aug 27;14(1):19902. doi: 10.1038/s41598-024-70064-8.
PubMed 39191809

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Nebulized Enriched Heparin to Treat no Critical Patients With Sars-Cov-2 - Triple Blind Clinical Trial
ClinicalTrials.gov ID: NCT04743011
Acronym / sponsor ID: EnHanCed / UPECLIN-MB-2
Conditions: Covid19
Keywords: COVID-19, Heparin, Antiviral Agents, Blood Coagulation, Clinical Protocols
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: UPECLIN HC FM Botucatu UnespUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 30 Nov 2021 (actual)
Study completion: 31 Dec 2021 (actual)
First posted: 8 Feb 2021 (actual)
Results: Posted 15 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Participants allocated to Group 1 (control) will receive inhalation with 0.9% saline solution applied 4/4 hours, for 7 days. Participants allocated to Group 2 (intervention) will receive high molecular weight inhaled heparin (2,5mg / mL 0.9% SF), at a 4/4 hour dose, for 7 days.

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants will receive inhalation with 5mL 0.9% saline solution (placebo), 4/4h, during the day period (5 doses).
Heparin sodium	Active comparator	Drug: Heparin sodiumParticipants will receive inhalation with 5mL 0.9% saline solution + 2,5mg of high molecular weight heparin - enriched heparin, 4/4h, during the day period (5 doses).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Signature and agreement to the Free Consent Form;
Both sexes, of any ethnic origin, aged between 18 and 90 years;
COVID-19 infected patients diagnosed by RT-PCR (reverse-transcriptase polymerase chain reaction) or with a strong suspicion of COVID-19 by clinical evaluation through compatible clinical and radiological findings;
Time of disease evolution less than 10 days;
Radiological diagnosis of grade 2A pneumonia, with gas exchange ratio > 200 on blood gas analysis (paO2 / pFiO2), characterizing mild hypoxemia;

Key exclusion criteria (5 listed)

No agreement to the terms of this study;
Moderate or severe respiratory failure requiring admission to the ICU and the need for invasive mechanical ventilation or non-invasive ventilation (NIV) with positive pressure;
Pregnancy or puerperium;
Patients with hematological diseases, coagulation disorders, use of anticoagulants, previous heparin-induced allergy or thrombocytopenia, thrombocytopenia with a count of fewer than 50,000 platelets / mm3;
COVID-19 not confirmed by RT-PCR within 72 hours of inclusion in the study.

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
Heparin sodiumAlso: Hepamax S BLAUNebulized inhalation of 5 mL of a solution containing high molecular weight heparin - enriched heparin - 2.5mg/mL and 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)	Drug	Heparin sodium
PlaceboAlso: Saline solution 0.9%, Physiological solution 0.9%Nebulized inhalation of 5 mL of 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)	Drug	Placebo

Primary outcome

Change in Activated Partial Thromboplastin Time (APTT) > 1.5 Seconds
Time frame: Immediately or up to 8 days after starting treatment
Safety-related to the use of high molecular weight heparin inhaled in patients with SARS-COV-2 through the assessment of hemorrhagic events of any nature, alteration of the coagulogram that indicates an APTT ratio > 1.5 or heparin-induced thrombocytopenia. In Brazilian standards, the APTT is measured in seconds and compared to a laboratory control for a ratio, which is used as a measurement.
Number of Participants With a Negative Viral Load in Nasal Swab Reverse Transcription Polymerase Chain Reaction (RT-PCR).
Time frame: Immediately or up to 8 days after starting treatment
Effectiveness related to the proposed treatment, based on the analysis of the viral load of SARS-COV-2 virus in the participants through a sequential assessment of the viral load in nasal swab RT-PCR. The measurement consists in patients that tested negative for any viral load at the end of the treatment.

8 secondary outcomes

Number of Participants That Develop Renal Failure
Time frame: Immediately or up to 8 days after starting treatment
Number of Participants That Develop Major Cardiovascular Events
Time frame: Immediately or up to 8 days after starting treatment
Number of Participants That Develop Deep Vein Thrombosis (DVT)
Time frame: Immediately or up to 8 days after starting treatment
Number of Participants That Develop Pancreatitis
Time frame: Immediately or up to 8 days after starting treatment
Number of Deaths Among Participants
Time frame: Immediately or up to 8 days after starting treatment
Number of Participants With Increased C Reactive Protein Test
Time frame: Immediately or up to 8 days after starting treatment
Number of Participants With Deterioration of Arterial Blood Gas paO2/pFiO2 Ratio
Time frame: Immediately or up to 8 days after starting treatment
Number of Participants With Increased Pulmonary Area Compromised (%)
Time frame: Immediately or up to 8 days after starting treatment

Results and safety

Results posted to the registry on 15 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	14	14
Heparin Sodium	13	13

Primary outcome: Change in Activated Partial Thromboplastin Time (APTT) > 1.5 Seconds

Time frame: Immediately or up to 8 days after starting treatment. Mean (Full Range). Unit: ratio

Measure	Placebo n = 14	Heparin Sodium n = 13
Value	0.95 (0.74 to 1.37)	1.10 (0.88 to 1.45)

Primary outcome: Number of Participants With a Negative Viral Load in Nasal Swab Reverse Transcription Polymerase Chain Reaction (RT-PCR).

Time frame: Immediately or up to 8 days after starting treatment. Count of participants. Unit: Participants

Measure	Placebo n = 14	Heparin Sodium n = 13
Value	8	8

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: No adverse effects were reported during the time frame of 7 days in which the groups were monitored.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Heparin Sodium	0 of 13 (0%)	0 of 13 (0%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 34752548Phelps MK, Olson LM, Patel MAVB, Thompson MJ, Murphy CV. Nebulized Heparin for Adult Patients With Smoke Inhalation Injury: A Review of the Literature. J Pharm Technol. 2020 Aug;36(4):130-140. doi: 10.1177/8755122520925774. Epub 2020 Jun 1.
Derived from this study: PubMed 39191809Ramos da Silva Grillo VT, Bertanha M, da Silva Rodrigues L, de Lima MA, Mellucci Filho PL, Rahal Guaragna Machado R, Durigon EL, Dias Sertorio N, de Assis Golim M, Moroz A, Marques Braz AM, de Moraes LN, Leite MA, Bonciani Nader H, de Campos GC, Rodrigues Guzzo Carvalho C, Florenca Cardoso F, Magro AJ, Caputo Nunes H, Tommasini Grotto RM, de Cassia Alvarado R, de Moura Campos Pardini MI, Lima Sobreira M, da Costa EAPN, Naime Barbosa A, Fortaleza CMCB. Nebulized enriched heparin improves respiratory parameters in patients with COVID-19: a phase I/II randomized and triple-blind clinical trial. Sci Rep. 2024 Aug 27;14(1):19902. doi: 10.1038/s41598-024-70064-8.
Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available

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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.

Matheus Bertanha, PhD principal investigator

São Paulo State University (Unesp)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Heparin sodium in people with Covid19, run by UPECLIN HC FM Botucatu Unesp at 2 sites in Brazil.

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 7 inclusion and 5 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 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Oct 2024). 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?

Change in Activated Partial Thromboplastin Time (APTT) > 1.5 Seconds (time frame: Immediately or up to 8 days after starting treatment). The study lists 2 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 NCT04743011, which also lists 2 linked publications.

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 15 Oct 2024.