Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE (ACTIV-4A)

April 7, 2024 updated by: Matthew Neal MD

A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19

This is a randomized, open label, adaptive platform trial to compare the effectiveness of antithrombotic and additional strategies for prevention of adverse outcomes in COVID-19 positive inpatients

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The severe acute respiratory syndrome coronavirus 2, which causes the highly contagious coronavirus disease 2019 (COVID-19), has resulted in a global pandemic.

The clinical spectrum of COVID-19 infection is broad, encompassing asymptomatic infection, mild upper respiratory tract illness, and severe viral pneumonia with respiratory failure and death. The risk of thrombotic complications is increased, even as compared to other viral respiratory illnesses, such as influenza. A pro-inflammatory cytokine response as well as induction of procoagulant factors associated with COVID-19 has been proposed to contribute to thrombosis as well as plaque rupture through local inflammation. Patients with COVID-19 are at increased risk for arterial and vein thromboembolism, with high rates observed despite thromboprophylaxis. Autopsy reports have noted micro and macro vascular thrombosis across multiple organ beds consistent with an early hypercoagulable state.

Notably, in COVID-19, data in the U.K. and U.S. document that infection and outcomes of infection are worse in African and Hispanic descent persons than in other groups. The reasons for this are uncertain.

Viral Infection and Thrombosis A large body of literature links inflammation and coagulation; altered hemostasis is a known complication of respiratory viral infections. Procoagulant markers are severely elevated in viral infections. Specifically, proinflammatory cytokines in viral infections upregulate expression of tissue factor, markers of thrombin generation, platelet activation, and down-regulate natural anticoagulant proteins C and S.

Studies have demonstrated significant risk of deep venous thrombosis (DVT), pulmonary embolism (PE), and myocardial infarction (MI) associated with viral respiratory infections. In a series of patients with fatal influenza H1N1, 75% had pulmonary thrombi on autopsy (a rate considerably higher than reported on autopsy studies among the general intensive care unit population). Incidence ratio for acute myocardial infarction in the context of Influenza A is over 10. Severe acute respiratory syndrome coronavirus-1 (SARS CoV-1) and influenza have been associated with disseminated intravascular coagulation (DIC), endothelial damage, DVT, PE, and large artery ischemic stroke. Patients with Influenza H1N1 and acute respiratory distress syndrome (ARDS) had a 23.3-fold higher risk for pulmonary embolism, and a 17.9-fold increased risk for deep vein thrombosis. Compared to those treated with systemic anticoagulation, those without treatment were 33 times more likely to suffer a VTE.

Thrombosis, both microvascular and macrovascular, is a prominent feature in multiple organs at autopsy in fatal cases of COVID-19. Thrombosis may thus contribute to respiratory failure, renal failure, and hepatic injury in COVID-19. The number of megakaryocytes in tissues is higher than in other forms of ARDS, and thrombi are platelet-rich based on specific staining. Thrombotic stroke has been reported in young COVID-19 patients with no cardiovascular risk factors. Both arterial and venous thrombotic events have been seen in increasing numbers of hospitalized patients infected with COVID-19. The incidence of thrombosis has ranged from 10 to 30% in hospitalized patients; however, this varies by type of thrombosis captured (arterial or vein) and severity of illness (ICU level care, requiring mechanical ventilation, etc.).

Additional treatment strategies Data from the multiplatform randomized controlled trial (mpRCT) demonstrated that (1) therapeutic dose anticoagulation with heparin was not beneficial in improving clinical outcomes compared to standard of care prophylactic dose heparin in severely ill (ICU level of care) patients, and (2) therapeutic dose anticoagulation with heparin was beneficial in improving organ support free days compared to standard of care prophylactic dose heparin in moderately ill (hospitalized and not requiring organ support) patients. However, there remains significant residual risk for adverse clinical outcomes and excess mortality for severely ill as well as moderately ill patients.

Antithrombotic regimens that are shown to be efficacious will be combined in clinical practice with other agents to treat COVID-19 hospitalized patients. This adaptive platform trial will test other promising agents when added to proven therapies, such as heparin. The rationale and risks for each agent will be included in the arm-specific appendix. Two specific agents to be added as arms, effective October 2021, include the P-selectin inhibitor, Crizanlizumab as well as SGLT2 inhibitors. P-selectin may play a proximal role in the inflammatory and thrombotic cascade in patients with COVID-19 and P-selectin inhibition may be a effective in preventing downstream sequelae. In addition, SGLT-2 inhibitors have been shown to decrease capillary leak and may promote vascular integrity in COVID-19.

This platform trial will have multiple arms, which may be dropped or added as the platform trial progresses. Sample size will be flexible: the trial will be stopped for efficacy or futility based on pre-determined statistical thresholds as defined in the arm-specific appendices. Each arm will have an adaptive component for determinations of futility or success.

Randomization assignments are at the participant level, stratified by enrolling site and by ICU level of care vs non-ICU level of care and/or other arm-specific criteria.

Study Type

Interventional

Enrollment (Actual)

3239

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
      • Braganca Paulista, Brazil
        • Hospital Universitario Sao Francisco de Assis
      • Porto Alegre, Brazil
        • União Brasileira de Educação e Assistência - Hospital São Lucas da PUCRS
      • Salvador, Brazil
        • Centro de Estudos Clínicos do Hospital Cárdio Pulmonar
      • São José do Rio Preto, Brazil
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
      • São Paulo, Brazil
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, Brazil
        • Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da USP-InCor-HCFMUSP
  • Italy
      • Caserta, Italy
        • Azienda Ospedaliero Sant Anna e San Sebastiano
      • Cotignola, Italy
        • Maria Cecilia Hospital , Cotignola, Ravenna
      • Ferrara, Italy
        • Università degli Studi di Ferrara, Ferrara
      • Firenze, Italy
        • Azienda Ospedaliero -Universitaria Careggi
      • Napoli, Italy
        • Policlinico di Napoli, Napoli
      • Palermo, Italy
        • AOU Policlinico di Palermo, Palermo
      • Sanremo, Italy
        • ASL-1 Imperiese, Sanremo
  • Spain
      • A Coruna, Spain
        • Hospital Universitario A Coruña
      • Almeria, Spain
        • Hospital Virgen del Mar
      • Lleida, Spain
        • Hospital Arnau de Vilanova
      • Madrid, Spain
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Universitario Ramon y Cajal
      • Salamanca, Spain
        • Hospital Clinico Universitario de Salamanca
      • Santiago de Compostela, Spain
        • Hospital Clinico Universitario de Santiago de Compostela
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama
    • Arizona
      • Tucson, Arizona, United States, 85719
        • University of Arizona
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Fontana, California, United States, 92335
        • Kaiser Permanente Fontana
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles
      • Los Angeles, California, United States, 90048
        • Smidt Heart Institute at Cedars-Sinai
      • San Diego, California, United States, 92103
        • UC San Diego Hillcrest
      • San Francisco, California, United States, 94110
        • Zuckerberg San Francisco General Hospital
      • San Francisco, California, United States, 94143
        • UCSF San Francisco
      • San Francisco, California, United States, 94410
        • Zuckerberg San Francisco General Hospital
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
    • Colorado
      • Denver, Colorado, United States, 80401
        • Denver Health and Hospital Authority
      • Grand Junction, Colorado, United States, 81501
        • St. Mary's Hospital & Regional Medical Center
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital and Medical Center
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida
      • Jacksonville, Florida, United States, 32216
        • Memorial Hospital
      • Tampa, Florida, United States, 33613
        • AdventHealth Tampa
    • Georgia
      • Atlanta, Georgia, United States, 30310
        • Morehouse School of Medicine
      • Atlanta, Georgia, United States, 30308
        • Emory
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Queens Medical Center
    • Illinois
      • Belleville, Illinois, United States, 62226
        • Memorial Hospital
      • Chicago, Illinois, United States, 60612
        • Cook County Health
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago Health (UIH)
      • Evergreen Park, Illinois, United States, 60805
        • OSF Little Company of Mary Medical Center (OSF LCM)
    • Iowa
      • Indianapolis, Iowa, United States, 46202
        • Indiana University Health Methodist Hospital
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Kansas University Medical Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University
      • Brighton, Massachusetts, United States, 02135
        • St Elizabeth's Medical Center
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
      • Worcester, Massachusetts, United States, 01655
        • University of Massachusetts
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Hennepin County Medical Center
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine, ACCS Research
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • University Medical Center of Southern Nevada
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Health
      • Englewood, New Jersey, United States, 07631
        • Englewood Health
      • Morristown, New Jersey, United States, 07960
        • Atlantic Health System
      • Newark, New Jersey, United States, 07103
        • Rutgers New Jersey Medical School
      • Pomona, New Jersey, United States, 08240
        • Atlanticare Regional Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Bronx, New York, United States, 10461
        • Montefiore Medical Center
      • Bronx, New York, United States, 10461
        • Jacobi Medical Center
      • Buffalo, New York, United States, 14220
        • Mercy Hospital Buffalo
      • New York, New York, United States, 10016
        • NYU Langone
      • New York, New York, United States, 10029
        • Mt. Sinai Hospital
      • New York, New York, United States, 10010
        • VA New York Harbor Healthcare System
      • Syracuse, New York, United States, 13210
        • SUNY Upstate University Hospital
      • Valhalla, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27704
        • Duke University Hospital
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest
    • Ohio
      • Akron, Ohio, United States, 44307
        • Cleveland Clinic Akron General
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
      • Cleveland, Ohio, United States, 44109
        • The MetroHealth System
      • Columbus, Ohio, United States, 43210
        • Ohio State Universtiy Wexner Medical Center
      • Toledo, Ohio, United States, 43608
        • Mercy Health St Vincent Medical Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Ascension St. John Clinical Research Institute
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health and Science University
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Research
      • Doylestown, Pennsylvania, United States, 18901
        • Doylestown Cardiology Associates
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S. Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15260
        • UPMC Presbyterian
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon and HCA Research Institute
      • Nashville, Tennessee, United States, 37207
        • Skyline Medical Center
    • Texas
      • Austin, Texas, United States, 78701
        • University of Texas at Austin
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Fort Worth, Texas, United States, 76104
        • Medical City Ft Worth
      • Temple, Texas, United States, 76508
        • Baylor Scott and White Medical Center - Temple
    • Virginia
      • Richmond, Virginia, United States, 23229
        • HCA Henrico Doctors Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Hospital
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University CTR
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • University of Wisconsin Hospital; Meriter Hospital (UW affiliated)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • Hospitalized for COVID-19
  • Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
  • Expected to require hospitalization for > 72 hours

Exclusion Criteria:

  • Imminent death
  • Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization
  • Pregnancy

Inclusion Criteria for Arm E

Inclusion criteria contained in the master protocol in addition to the following:

Moderate illness severity - defined as non-ICU level of care at the time of randomization (not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO) OR Severe illness severity - defined as ICU level of care at the time of randomization (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)

For moderate illness severity, participants are required to meet one or more of the following risk criteria:

  1. Age ≥ 65 years or

  2. ≥2 of the following -

    • O2 supplementation > 2 liters per minute
    • BMI ≥ 35
    • GFR ≤ 60
    • History of Type 2 diabetes
    • History of heart failure (regardless of ejection fraction)
    • D dimer ≥ 2x the site's upper limit of normal (ULN)
    • Troponin ≥ 2x the site's ULN
    • BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
    • CRP ≥50 mg/L

Exclusion Criteria for Arm E

  • Exclusion criteria contained in the master protocol, and
  • Any condition that, in the opinion of the investigator, precludes the use of crizanlizumab such as uncontrolled bleeding or severe anemia (hemoglobin<4 g/dL)
  • Open label treatment with crizanlizumab within the past three months

Inclusion Criteria for Arm F

Inclusion criteria contained in the master protocol in addition to the following:

Moderate illness severity - defined as non-ICU level of care at the time of randomization (not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO)) OR Severe illness severity - defined as ICU level of care at the time of randomization (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)

For moderate illness severity, participants are required to meet one or more of the following risk criteria:

  1. Age ≥ 65 years or

  2. ≥2 of the following-

    • O2 supplementation > 2 liters per minute
    • BMI ≥ 35
    • GFR ≤ 60
    • History of Type 2 diabetes
    • History of heart failure (regardless of ejection fraction)
    • D dimer ≥ 2x the site's upper limit of normal (ULN)
    • Troponin ≥ 2x the site's ULN
    • BNP≥100 pg/mL or NT-proBNP≥300 pg/mL
    • CRP ≥50 mg/L

Exclusion Criteria for Arm F

In addition to the exclusion criteria noted in the master protocol, arm-specific exclusion criteria are as follows:

  • Known hypersensitivity to any SGLT2 inhibitors
  • Type 1 diabetes
  • History of diabetic ketoacidosis
  • eGFR <20 and/or requirement for renal replacement therapy

  • Open label treatment with any SGLT2 inhibitor

    • Based on a recommendation from the ACTIV4 DSMB on December 19, 2020, enrollment of patients requiring ICU level of care into the therapeutic anti-coagulation arm was stopped due to meeting a futility threshold and a potential for harm for this sub-group could not be excluded. Enrollment continues for moderately ill hospitalized COVID-19 patients.
    • Based on a recommendation from the ACTIV4 DSMB on June 18, 2021, enrollment of patients not requiring ICU level of care and randomized to P2Y12 or standard care was stopped due to meeting a futility threshold. Enrollment continues for severely ill (ICU level of care) hospitalized COVID-19 patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Therapeutic Dose Anticoagulation

increased dose of heparin above standard of care.

1.0 - This arm was stopped in severe patients in December 2020 and results are published in PMID: 34351722 (NEJM, August, 2021) (see reference section for citation). This arm was stopped for moderate patients in January 2021.
Drug: theraputic heparin
increased dose of heparin above standard of care.
Other Names:
  • Enoxaparin
  • Heparin
  • unfractionated heparin
  • Dalteparin
  • Tinzaparin
Other: Prophylactic Dose Anticoagulation

Heparin standard of care

1.0 - this arm was stopped for all patients in January, 2021 and results are published in PMID: 34351721 (NEJM, August, 2021) (see reference section for citation)
Drug: prophylactic heparin
standard of care dose of heparin
Other Names:
  • Heparin
  • enoxaparin
  • Tinzaparin
  • dalteparin
  • Fondparinux
Other: Therapeutic Dose Anticoagulation + P2Y12 inhibitor

increased dose of heparin above standard of care with an added P2Y12 inhibitor

This Arm enrolled moderate illness patients only. Enrollment of moderate illness patients in the trial was ended per DSMB on June 19, 2021 and results are published in PMID: PMID: 35040887 (JAMA, January, 2022) (see reference section for citation)
Drug: theraputic heparin
increased dose of heparin above standard of care.
Other Names:
  • Enoxaparin
  • Heparin
  • unfractionated heparin
  • Dalteparin
  • Tinzaparin
Drug: P2Y12
added P2Y12 inhibitor
Other Names:
  • Prasugrel
  • Clopidogrel
  • Ticagrelor
Other: Prophylactic Dose Anticoagulation + P2Y12 inhibitor

Heparin standard of care with an added P2Y12 inhibitor

This Arm enrolled severe illness patients only. Enrollment of severe illness patients in the trial was ended per DSMB in June 2022.
Drug: prophylactic heparin
standard of care dose of heparin
Other Names:
  • Heparin
  • enoxaparin
  • Tinzaparin
  • dalteparin
  • Fondparinux
Drug: P2Y12
added P2Y12 inhibitor
Other Names:
  • Prasugrel
  • Clopidogrel
  • Ticagrelor
Other: Standard of Care + Crizanlizumab

Standard of care plus crizanlizumab infusion

This arm will enroll moderate and severe illness patients

This arm was ended for all patients per the DSMB in September 2022.
Drug: Crizanlizumab Injection
crizanlizumab injection
Other: Standard of Care + SGLT2 inhibitor

Standard of care plus SGLT2 inhibitor

This arm will enroll moderate and severe illness patients

This arm was ended in March 2023
Drug: SGLT2 inhibitor
sglt2 inhibitor
Other Names:
  • dapagliflozin
  • empagliflozin
  • canagliflozin
  • ertugliflozin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
21 Day Organ Support (respiratory or vasopressor) Free Days
Time Frame: 21 days from study enrollment
which is defined as the number of days that a patient is alive and free of organ support through the first 21 days after trial entry. Organ Support is defined as receipt of non-invasive mechanical ventilation, high flow nasal canula oxygen, mechanical ventilation, or vasopressor therapy, with death at any time during the index hospitalization assigned -1 days.
21 days from study enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Endpoint all cause mortality
Time Frame: 28 days from study enrollment
Categorization of the primary endpoint into a three-level ordinal outcome (Death, invasive mechanical ventilation without death, neither invasive mechanical ventilation nor death)
28 days from study enrollment
Other Platform Secondary Endpoints of Morbidity and Hospitalization
Time Frame: 28 days from study enrollment
Categorization of the primary endpoint into a three-level ordinal outcome (Death, organ support (any respiratory or cardiovascular) without death, neither organ support nor death) (for moderate illness severity at enrollment)
28 days from study enrollment
Days free of death
Time Frame: 28 days from enrollment
Days free of death and respiratory and cardiovascular organ support and renal replacement therapy (RRT) during Index Hospitalization through Day 28.
28 days from enrollment
Death Composite
Time Frame: 28 days from enrollment
Composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke at hospital discharge or 28 days, whichever occurs first.
28 days from enrollment
Acute kidney injury
Time Frame: 90 days from enrollment
Individual endpoints comprising the primary and secondary endpoint components; death during hospitalization, WHO clinical scale and 90 day mortality
90 days from enrollment

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint of Major Bleeding
Time Frame: 28 days from study enrollment
Major bleeding (as defined by the ISTH)
28 days from study enrollment
Secondary Safety Endpoint of HIT
Time Frame: 28 days from study enrollment
Confirmed heparin induced thrombocytopenia (HIT)
28 days from study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Matthew Neal MD

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Scott Solomon, MD, Brigham and Women's Hospital
  • Principal Investigator: Mikhail Kosiborod, MD, Saint Lukes
  • Study Chair: MATTHEW D NEAL, MD, University of Pittsburgh
  • Study Chair: Judith Hochman, MD, New York University Grossman School of Medicine
  • Principal Investigator: Jeffrey Berger, MD, New York University Grossman School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2020

Primary Completion (Actual)

August 31, 2023

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 6, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 7, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACTIV-4 ACUTE
  • 1OT2HL156812-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be shared as per NIH guidelines.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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