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Enriched Heparin Anti COVID-19 Trial (EnHanCed)

2021년 9월 27일 업데이트: Matheus Bertanha, PhD, UPECLIN HC FM Botucatu Unesp

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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (예상)

50

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 브라질
    • SP
      • Botucatu, SP, 브라질, 18607030
        • 아직 모집하지 않음
        • School of Medicine at Botucatu- Paulista State University- UNESP, São Paulo, Brazil
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Matheus Bertanha, PhD
    • Sao Paulo
      • Botucatu, Sao Paulo, 브라질, 18618970
        • 모병
        • Hospital das Clinicas de Boucatu
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Matheus Bertanha, Ph.D.
        • 부수사관:
          • Pedro L Mellucci Filho, M.D.
        • 부수사관:
          • Vinicius R Grillo, M.D.
        • 부수사관:
          • Nathalia D Sertorio, M.D.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
위약 비교기: Placebo
Participants will receive inhalation with 5mL 0.9% saline solution (placebo), 4/4h, during the day period (5 doses).
의약품: Placebo
Nebulized inhalation of 5 mL of 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)
다른 이름들:
  • 식염수 0.9%
  • Physiological solution 0.9%
활성 비교기: Heparin sodium
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).
의약품: Heparin sodium
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)
다른 이름들:
  • Hepamax S BLAU

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in activated partial thromboplastin time (APTT) > 1.5
기간: 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 increase in APTT> 1.5, heparin-induced thrombocytopenia.
Immediately or up to 8 days after starting treatment
Viral load in nasal swab reverse transcription polymerase chain reaction (RT-PCR).
기간: 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.
Immediately or up to 8 days after starting treatment

2차 결과 측정

결과 측정
측정값 설명
기간
Number of participants needing supplemental oxygen therapy
기간: Immediately or up to 8 days after starting treatment
Worsening of respiratory parameters measured by the need for supplemental oxygen therapy at greater doses than 5L/min;
Immediately or up to 8 days after starting treatment
Number of participants needing mechanical pulmonary ventilation
기간: Immediately or up to 8 days after starting treatment
Worsening of respiratory parameters measured by the need of definitive airway assisted pulmonary ventilation;
Immediately or up to 8 days after starting treatment
Number of hospitalization days
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by a prolonged hospital stay;
Immediately or up to 8 days after starting treatment
Number of participants that develop renal failure
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by renal failure through measurement of urea and creatinine;
Immediately or up to 8 days after starting treatment
Number of participants that develop major cardiovascular events
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by major cardiovascular events (pulmonary embolism, acute myocardial infarction)
Immediately or up to 8 days after starting treatment
Number of participants transferred to the intensive care unit (ICU)
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by need for Intensive Care Unit (ICU) treatment;
Immediately or up to 8 days after starting treatment
Number of participants presenting secondary pulmonary bacterial infections
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by presentation of secondary pulmonary bacterial infections (pneumonia);
Immediately or up to 8 days after starting treatment
Number of participants that develop deep vein thrombosis (DVT)
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by deep vein thrombosis (DVT);
Immediately or up to 8 days after starting treatment
Number of participants that develop pancreatitis
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by pancreatitis through measurement of amylase (> 200 U/L);
Immediately or up to 8 days after starting treatment
Number of participants that need corticosteroid therapy
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by need for hydrocortisone, dexamethasone or other corticosteroids due to inflammatory pulmonary disease;
Immediately or up to 8 days after starting treatment
Number of deaths among participants
기간: Immediately or up to 8 days after starting treatment
Worsening of clinical parameters characterized by death;
Immediately or up to 8 days after starting treatment
Number of participants with increased white blood cell count
기간: Immediately or up to 8 days after starting treatment
Worsening of laboratory parameters measured by increased white blood cell count (>10.000 cells/mm³);
Immediately or up to 8 days after starting treatment
Number of participants with increased C reactive protein test
기간: Immediately or up to 8 days after starting treatment
Worsening of laboratory parameters measured by increase in C reactive protein test (>3.00mg/L);
Immediately or up to 8 days after starting treatment
Number of participants with deterioration of arterial blood gas paO2/pFiO2 ratio
기간: Immediately or up to 8 days after starting treatment
Worsening of laboratory parameters measured by alterations in arterial blood gas measured by paO2/pFiO2 < 200;
Immediately or up to 8 days after starting treatment
Number of participants with altered sodium
기간: Immediately or up to 8 days after starting treatment
Worsening of laboratory parameters measured by alterations in sodium (< 135mEq/L or > 145mEq/L)
Immediately or up to 8 days after starting treatment
Number of participants with altered potassium
기간: Immediately or up to 8 days after starting treatment
Worsening of laboratory parameters measured by alterations in potassium (< 3,5mEq/L or > 5,5mEq/L);
Immediately or up to 8 days after starting treatment
Number of participants with increased pulmonary area compromised (%)
기간: Immediately or up to 8 days after starting treatment
Worsening of tomographic parameters measured by the pulmonary area compromised by the infection and/or inflammation.
Immediately or up to 8 days after starting treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

UPECLIN HC FM Botucatu Unesp

수사관

  • 수석 연구원: Matheus Bertanha, PhD, São Paulo State University (Unesp)

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2021년 6월 1일

기본 완료 (예상)

2021년 11월 30일

연구 완료 (예상)

2021년 12월 31일

연구 등록 날짜

최초 제출

2021년 2월 3일

QC 기준을 충족하는 최초 제출

2021년 2월 5일

처음 게시됨 (실제)

2021년 2월 8일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 9월 29일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 9월 27일

마지막으로 확인됨

2021년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • UPECLIN-MB-2

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

There is a plan to make IPD and related data dictionaries available

IPD 공유 기간

The summary data will be published or made available 6 months after publication.

IPD 공유 액세스 기준

Epidemiological data, clinical data, and patient evolution will be shared during the study only for researchers who request access to the data. Access requests will be analyzed by the main researcher, and they will only be released for scientific purposes.

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • 수액
  • ICF
  • CSR

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

코로나19에 대한 임상 시험

Placebo에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Slovenia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다