Enriched heparin for the treatment of COVID-19

Inhalational high molecular weight heparin for the treatment of Sars-CoV-2

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-7y8j2bs

Enrollment

Unknown

Registered

2021-02-10

Start date

2021-06-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infections

Interventions

Participants will be divided into 2 groups randomized 1:1, randomly. In this way, they will receive a sequential inclusion number from an electronically drawn number table and will receive the propose

RT-PCR for COVID-19 (visits 1,3, 6, 8, 9)

Computed tomography of the chest for pulmonary evaluation (visits 1 and 9)

Complete blood cell count (visits 1,3, 6, 8, 9)

D-dimer (visits 1,3, 6, 8, 9)

Complete coagulogram (visits 1,3, 6, 8, 9)

Urea and creatinine (visits 1,3, 6, 8, 9)

Fasted blood glucose (visits 1,3, 6, 8, 9)

C-reactive protein (CRP) (visits 1,3, 6, 8, 9)

Arterial blood gas analysis (visits 1.3, 6, 8, 9)

Amylase (visits 1,3, 6, 8, 9).

23279

26532

11241

33872

23484

1798

22178

11957

10505

Eligibility

Age

18 Years to 90 Years

Inclusion criteria

Inclusion criteria: Sign and agree to the Informed Consent Form; Both sexes, of any ethnic origin, aged between 18 and 90 years; COVID-19 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; 4. Time of disease evolution less than 10 days; 5. Radiological diagnosis of pneumonia grade 2 A, with gas exchange ratio> 200 on blood gas analysis (paO2 / pFiO2), characterizing mild hypoxemia; 6. Indication of hospital treatment regime, provided that the period of hospitalization before inclusion is not more than 24 hours; 7. Need for supplemental oxygen therapy (O2) less than 5L / min.

Exclusion criteria

Exclusion criteria: Do not agree with the terms of the study; Moderate or severe respiratory failure requiring admission to the Intensive Care Unit (ICU) with the need for invasive mechanical ventilation or non-invasive ventilation with positive pressure (NIV); Pregnancy or puerperium; People with hematological diseases, coagulation disorders, use of anticoagulants; previous heparin-induced allergy or thrombocytopenia, thrombocytopenia with a count of less than 50.000 platelets / mm3; No diagnostic confirmation of COVID-19 by RT-PCR within 72 hours of inclusion in the study.

Design outcomes

Primary

Measure	Time frame
Safety: related to the use of inhalational high molecular weight heparin in patients with SARS-COV-2 through the assessment of hemorrhagic events of any nature, alteration of the coagulogram that indicates an increase in Activated Partial Thromboplastin Time (APTT)> 1, 5 and heparin-induced thrombocytopenia.;Efficacy: relative to the proposed treatment, through the analysis of the viral load of the SARS-COV-2 virus in the participants treated by the sequential evaluation of the viral load in RT-PCR of nasal Swab.	—

Measure

Time frame

Safety: related to the use of inhalational high molecular weight heparin in patients with SARS-COV-2 through the assessment of hemorrhagic events of any nature, alteration of the coagulogram that indicates an increase in Activated Partial Thromboplastin Time (APTT)> 1, 5 and heparin-induced thrombocytopenia.;Efficacy: relative to the proposed treatment, through the analysis of the viral load of the SARS-COV-2 virus in the participants treated by the sequential evaluation of the viral load in RT-PCR of nasal Swab.

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Secondary

Measure	Time frame
Worsening of respiratory parameters measured by the need for supplemental oxygen therapy at greater doses than 5L/min;;Worsening of respiratory parameters measured by the need of definitive airway assisted pulmonary ventilation;;Worsening of clinical parameters characterized by a prolonged hospital stay;;Worsening of clinical parameters characterized by renal failure through measurement of urea and creatinine;;Worsening of clinical parameters characterized by major cardiovascular events (pulmonary embolism, acute myocardial infarction);;Worsening of clinical parameters characterized by need for Intensive Care Unit (ICU) treatment;;Worsening of clinical parameters characterized by presentation of secondary pulmonary bacterial infections (pneumonia);;Worsening of clinical parameters characterized by deep vein thrombosis (DVT);;Worsening of clinical parameters characterized by pancreatitis through measurement of amylase (> 200 U/L);;Worsening of clinical parameters characterized by need for hydrocortisone, dexamethasone or other corticosteroids due to inflammatory pulmonary disease;;Worsening of clinical parameters characterized by death;;Worsening of laboratory parameters measured by increased white blood cell count (>10.000 cells/mm³);;Worsening of laboratory parameters measured by increase in C reactive protein test (>3.00mg/L);;Worsening of laboratory parameters measured by alterations in arterial blood gas measured by paO2/pFiO2 145mEq/L);;Worsening of laboratory parameters measured by alterations in potassium ( 5,5mEq/L);;Worsening of tomographic parameters measured by the pulmonary area compromised by the infection and/or inflammation.	—

Measure

Time frame

Worsening of respiratory parameters measured by the need for supplemental oxygen therapy at greater doses than 5L/min;;Worsening of respiratory parameters measured by the need of definitive airway assisted pulmonary ventilation;;Worsening of clinical parameters characterized by a prolonged hospital stay;;Worsening of clinical parameters characterized by renal failure through measurement of urea and creatinine;;Worsening of clinical parameters characterized by major cardiovascular events (pulmonary embolism, acute myocardial infarction);;Worsening of clinical parameters characterized by need for Intensive Care Unit (ICU) treatment;;Worsening of clinical parameters characterized by presentation of secondary pulmonary bacterial infections (pneumonia);;Worsening of clinical parameters characterized by deep vein thrombosis (DVT);;Worsening of clinical parameters characterized by pancreatitis through measurement of amylase (> 200 U/L);;Worsening of clinical parameters characterized by need for hydrocortisone, dexamethasone or other corticosteroids due to inflammatory pulmonary disease;;Worsening of clinical parameters characterized by death;;Worsening of laboratory parameters measured by increased white blood cell count (>10.000 cells/mm³);;Worsening of laboratory parameters measured by increase in C reactive protein test (>3.00mg/L);;Worsening of laboratory parameters measured by alterations in arterial blood gas measured by paO2/pFiO2 145mEq/L);;Worsening of laboratory parameters measured by alterations in potassium ( 5,5mEq/L);;Worsening of tomographic parameters measured by the pulmonary area compromised by the infection and/or inflammation.

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Countries

Brazil

Contacts

Public ContactAdriano Maeda

adriano.maeda@gmail.com+55 41 22101490

Outcome results

None listed

Source: REBEC (via WHO ICTRP)