<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04410328</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2020001469</org_study_id>
    <nct_id>NCT04410328</nct_id>
  </id_info>
  <brief_title>Aggrenox To Treat Acute Covid-19</brief_title>
  <acronym>ATTAC-19</acronym>
  <official_title>A Randomized Controlled Trial to Evaluate the Outcomes With Aggrenox in Patients With SARS-CoV-2 Infection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2&#xD;
      infection with symptoms consistent with COVID-19. An anticipated total of 132 participants&#xD;
      will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER&#xD;
      200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with&#xD;
      receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants&#xD;
      will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and&#xD;
      laboratory outcomes of all the participants enrolled in the study will be evaluated at the&#xD;
      end of the study to explore if there is any difference in the outcomes between 2 groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Purpose/Specific Aims: The purpose of this study is to explore the efficacy of Aggrenox in&#xD;
      patients with SARS-CoV-2 infection with symptoms consistent with COVID-19.&#xD;
&#xD;
      Among 132 SARS-CoV-2 patients (66 patients in each randomized arm), we will determine the&#xD;
      efficacy of Aggrenox on clinical outcomes.&#xD;
&#xD;
      Hypotheses / Research Question(s) Compared to standard care, the addition of Aggrenox&#xD;
      (Dipyridamole ER 200mg/ Aspirin 25mg), to standard care will result in improvement in the&#xD;
      composite COVID ordinal scale at day 15. Additionally, combined Aggrenox (Dipyridamole ER&#xD;
      200mg/ Aspirin 25mg orally/enterally), and standard care will reduce the need for&#xD;
      ventilation, length of mechanical ventilation, hospital length of stay, ICU length of stay,&#xD;
      decrease risk of thromboembolic complications and improve survival more than standard care&#xD;
      alone in SARS-CoV-2 patients.&#xD;
&#xD;
      Research Design and Methods Randomized design. Participants will be randomized 1:1 to&#xD;
      Aggrenox or standard treatment. Arm 1: Active Comparator: (Aggrenox (Dipyridamole ER 200mg/&#xD;
      Aspirin 25mg orally/enterally).&#xD;
&#xD;
      Participants will receive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2&#xD;
      times daily (FDA-recommended dose) starting on the day of enrollment for a total of 2 weeks +&#xD;
      standard care.&#xD;
&#xD;
      Arm 2: Standard care Comparator: Participants will receive standard care starting on the day&#xD;
      of enrollment for a total of 2 weeks.&#xD;
&#xD;
      The investigators will perform a randomized, 2-arm, open-label single-site pilot study to&#xD;
      evaluate the effect of oral Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally),&#xD;
      on clinical outcomes in patients with SARS-CoV-2. In this research proposal, investigators&#xD;
      will randomly assign 132 consenting participants with diagnosis of SARS-CoV-2 to two&#xD;
      treatment groups: 1) Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) +&#xD;
      standard care and 2) standard care alone. Participants will be screened, enrolled, receive&#xD;
      treatment and followed for 28 days. The study aim and procedure will be explained to every&#xD;
      eligible subject and informed consent will be obtained from interested subjects or authorized&#xD;
      proxy to participate in the study. The investigators will collect demographic, clinical,&#xD;
      laboratory and radiological data. The patients would be followed daily for 2 weeks after&#xD;
      enrollment while the patient is in the hospital and once discharged, they will be called&#xD;
      every 3rd day to follow up on the symptoms.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Actual">October 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 15, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Arm 1: Aggrenox plus standard care. Participants will receive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily (FDA-recommended dose) starting on the day of enrollment for a total of 2 weeks.&#xD;
Arm 2: Standard care. Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.&#xD;
The investigators will perform a randomized, 2-arm, open-label single-site pilot study to evaluate the effect of oral Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), on clinical outcomes in patients with SARS-CoV-2. In this research proposal, the investigators will randomly assign 132 consenting participants with diagnosis of SARS-CoV-2 to two treatment groups: 1) Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) + standard care and 2) standard care alone. Participants will be screened, enrolled, receive treatment and followed for 28 days.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Covid (Coronavirus Disease-19) Ordinal Scale</measure>
    <time_frame>15 days</time_frame>
    <description>Change in composite COVID ordinal scale at day 15. Ordinal scale: 1) not hospitalized with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen; 4) hospitalized, requiring oxygen; 5) hospitalized, requiring high-flow oxygen therapy, or noninvasive ventilation; 6) hospitalized, requiring invasive ventilation; 7) ventilation plus additional organ support such as pressors, renal replacement therapy and ECMO and 8) death.&#xD;
COVID Ordinal Scale ranges from 1 to 8, with score 1 on the scale corresponds to an ambulatory patient with minimal symptoms and score 8 on the scale corresponds to death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>15 days</time_frame>
    <description>All-cause mortality assessed on day 15.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>All-cause mortality assessed on day 28.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental Oxygen</measure>
    <time_frame>28 days</time_frame>
    <description>Supplemental Oxygen-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Invasive-ventilator</measure>
    <time_frame>28 days</time_frame>
    <description>Invasive-ventilator-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>28 days</time_frame>
    <description>ICU-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital stay</measure>
    <time_frame>28 days</time_frame>
    <description>Hospital-free days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory markers</measure>
    <time_frame>15 days</time_frame>
    <description>Decrease in the markers D-dimer/ Ferritin/ C-reactive protein</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thromboembolic complications</measure>
    <time_frame>28 days</time_frame>
    <description>Thromboembolic complications including stroke</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID ordinal scale</measure>
    <time_frame>28 days</time_frame>
    <description>COVID ordinal scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">99</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Participants receiving Dipyridamole and Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants receiving standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care</intervention_name>
    <description>Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.</description>
    <arm_group_label>Participants receiving Dipyridamole and Aspirin</arm_group_label>
    <other_name>Aggrenox</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.</description>
    <arm_group_label>Participants receiving Dipyridamole and Aspirin</arm_group_label>
    <arm_group_label>Participants receiving standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥18 years.&#xD;
&#xD;
          2. Hospitalization.&#xD;
&#xD;
          3. SARS-CoV-2 viral nucleic acid positive within 3 days.&#xD;
&#xD;
          4. Lab test result pending plus a high clinical suspicion for SARS-CoV-2 (fever and cough&#xD;
             for ≤ 7 days, bilateral pulmonary infiltrates on imaging or new hypoxemia with spO2&#xD;
             ≤94% on room air or no alternative explanation for respiratory symptoms).&#xD;
&#xD;
          5. Willing and able to provide consent or by authorized proxy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. G-6PD deficiency.&#xD;
&#xD;
          3. Use of antiplatelet agents including inhibitor of P2Y12 ADP platelet receptors,&#xD;
             phosphodiesterase inhibitors, and Glycoprotein IIB/IIIA inhibitors.&#xD;
&#xD;
          4. On therapeutic anticoagulation with coumadin, heparin and direct oral anticoagulants.&#xD;
&#xD;
          5. Vasodilatory shock.&#xD;
&#xD;
          6. Patient with known ongoing angina, recent myocardial infarction and sub-valvular&#xD;
             aortic stenosis.&#xD;
&#xD;
          7. Active gastric or duodenal ulcer or any bleeding disorder.&#xD;
&#xD;
          8. Hemoglobin &lt;9 mg/dL, platelet count of &lt;30,000 /mm3.&#xD;
&#xD;
          9. Acute respiratory infection for &gt;10 days.&#xD;
&#xD;
         10. Known allergy/hypersensitivity to Dipyridamole and/or Aspirin.&#xD;
&#xD;
         11. Severe hepatic or renal insufficiency.&#xD;
&#xD;
         12. Uncontrolled hypertension defined as systolic &gt; 180 mm Hg or diastolic &gt; 100 mm Hg.&#xD;
&#xD;
         13. Patients with known allergy to NSAIDs&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Amit Singla, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rutgers New Jersey Medical School University Hospital</name>
      <address>
        <city>Newark</city>
        <state>New Jersey</state>
        <zip>07103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>International Severe Acute Respiratory emergning Infection Consortium Case Reports. https://isaric.tghn.org.</citation>
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  <results_reference>
    <citation>Macatangay BJC, Jackson EK, Abebe KZ, Comer D, Cyktor J, Klamar-Blain C, Borowski L, Gillespie DG, Mellors JW, Rinaldo CR, Riddler SA. A Randomized, Placebo-Controlled, Pilot Clinical Trial of Dipyridamole to Decrease Human Immunodeficiency Virus-Associated Chronic Inflammation. J Infect Dis. 2020 Apr 27;221(10):1598-1606. doi: 10.1093/infdis/jiz344.</citation>
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    <citation>Li Z LX, Huang Yi-Y et al. FEP-based screening prompts drug repositioning against COVID-19. 2020.</citation>
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    <citation>Liu X LZ, Liu S et al. . Therapeutic effects of dipyridamole on COVID-19 patients with coagulation dysfunction. 2020.</citation>
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    <citation>Kohler D, Streienberger A, Morote-Garcia JC, Granja TF, Schneider M, Straub A, Boison D, Rosenberger P. Inhibition of Adenosine Kinase Attenuates Acute Lung Injury. Crit Care Med. 2016 Apr;44(4):e181-9. doi: 10.1097/CCM.0000000000001370.</citation>
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    <citation>Fata-Hartley CL, Palmenberg AC. Dipyridamole reversibly inhibits mengovirus RNA replication. J Virol. 2005 Sep;79(17):11062-70. doi: 10.1128/JVI.79.17.11062-11070.2005.</citation>
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    <citation>Weyrich AS, Skalabrin EJ, Kraiss LW. Targeting the inflammatory response in secondary stroke prevention: a role for combining aspirin and extended-release dipyridamole. Am J Ther. 2009 Mar-Apr;16(2):164-70. doi: 10.1097/MJT.0b013e31814b17bf.</citation>
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    <citation>Cao B, Wang Y, Wen D, Liu W, Wang J, Fan G, Ruan L, Song B, Cai Y, Wei M, Li X, Xia J, Chen N, Xiang J, Yu T, Bai T, Xie X, Zhang L, Li C, Yuan Y, Chen H, Li H, Huang H, Tu S, Gong F, Liu Y, Wei Y, Dong C, Zhou F, Gu X, Xu J, Liu Z, Zhang Y, Li H, Shang L, Wang K, Li K, Zhou X, Dong X, Qu Z, Lu S, Hu X, Ruan S, Luo S, Wu J, Peng L, Cheng F, Pan L, Zou J, Jia C, Wang J, Liu X, Wang S, Wu X, Ge Q, He J, Zhan H, Qiu F, Guo L, Huang C, Jaki T, Hayden FG, Horby PW, Zhang D, Wang C. A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19. N Engl J Med. 2020 May 7;382(19):1787-1799. doi: 10.1056/NEJMoa2001282. Epub 2020 Mar 18.</citation>
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  <verification_date>January 2022</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>January 31, 2022</last_update_submitted>
  <last_update_submitted_qc>January 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Amit Singla, MD, FAANS</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV</keyword>
  <keyword>Aggrenox</keyword>
  <keyword>Dipyridamole</keyword>
  <keyword>Aspirin</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
    <mesh_term>Dipyridamole</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 17, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT04410328/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>June 1, 2022</submitted>
    <returned>June 23, 2022</returned>
    <submitted>December 22, 2022</submitted>
    <returned>January 19, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04410328
org study id: Pro2020001469
nct id: NCT04410328
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: Yes
is us export: No
The purpose of this study is to explore the efficacy of Aggrenox in patients with SARS-CoV-2
      infection with symptoms consistent with COVID-19. An anticipated total of 132 participants
      will be randomly divided almost equally into 2 groups: one group will receive Dipyridamole ER
      200mg/ Aspirin 25mg orally/enterally along with the standard of care and the other group with
      receive the standard of care only but no Dipyridamole ER 200mg/ Aspirin 25mg. Participants
      will be screened, enrolled, receive treatment, and followed for 28 days. The clinical and
      laboratory outcomes of all the participants enrolled in the study will be evaluated at the
      end of the study to explore if there is any difference in the outcomes between 2 groups.
Purpose/Specific Aims: The purpose of this study is to explore the efficacy of Aggrenox in
      patients with SARS-CoV-2 infection with symptoms consistent with COVID-19.

      Among 132 SARS-CoV-2 patients (66 patients in each randomized arm), we will determine the
      efficacy of Aggrenox on clinical outcomes.

      Hypotheses / Research Question(s) Compared to standard care, the addition of Aggrenox
      (Dipyridamole ER 200mg/ Aspirin 25mg), to standard care will result in improvement in the
      composite COVID ordinal scale at day 15. Additionally, combined Aggrenox (Dipyridamole ER
      200mg/ Aspirin 25mg orally/enterally), and standard care will reduce the need for
      ventilation, length of mechanical ventilation, hospital length of stay, ICU length of stay,
      decrease risk of thromboembolic complications and improve survival more than standard care
      alone in SARS-CoV-2 patients.

      Research Design and Methods Randomized design. Participants will be randomized 1:1 to
      Aggrenox or standard treatment. Arm 1: Active Comparator: (Aggrenox (Dipyridamole ER 200mg/
      Aspirin 25mg orally/enterally).

      Participants will receive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2
      times daily (FDA-recommended dose) starting on the day of enrollment for a total of 2 weeks +
      standard care.

      Arm 2: Standard care Comparator: Participants will receive standard care starting on the day
      of enrollment for a total of 2 weeks.

      The investigators will perform a randomized, 2-arm, open-label single-site pilot study to
      evaluate the effect of oral Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally),
      on clinical outcomes in patients with SARS-CoV-2. In this research proposal, investigators
      will randomly assign 132 consenting participants with diagnosis of SARS-CoV-2 to two
      treatment groups: 1) Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) +
      standard care and 2) standard care alone. Participants will be screened, enrolled, receive
      treatment and followed for 28 days. The study aim and procedure will be explained to every
      eligible subject and informed consent will be obtained from interested subjects or authorized
      proxy to participate in the study. The investigators will collect demographic, clinical,
      laboratory and radiological data. The patients would be followed daily for 2 weeks after
      enrollment while the patient is in the hospital and once discharged, they will be called
      every 3rd day to follow up on the symptoms.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Arm 1: Aggrenox plus standard care. Participants will receive Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily (FDA-recommended dose) starting on the day of enrollment for a total of 2 weeks.
Arm 2: Standard care. Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
The investigators will perform a randomized, 2-arm, open-label single-site pilot study to evaluate the effect of oral Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), on clinical outcomes in patients with SARS-CoV-2. In this research proposal, the investigators will randomly assign 132 consenting participants with diagnosis of SARS-CoV-2 to two treatment groups: 1) Aggrenox (Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally) + standard care and 2) standard care alone. Participants will be screened, enrolled, receive treatment and followed for 28 days.
primary purpose: Treatment
masking: None (Open Label)
measure: Covid (Coronavirus Disease-19) Ordinal Scale
time frame: 15 days
description: Change in composite COVID ordinal scale at day 15. Ordinal scale: 1) not hospitalized with resumption of normal activities; 2) not hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen; 4) hospitalized, requiring oxygen; 5) hospitalized, requiring high-flow oxygen therapy, or noninvasive ventilation; 6) hospitalized, requiring invasive ventilation; 7) ventilation plus additional organ support such as pressors, renal replacement therapy and ECMO and 8) death.
COVID Ordinal Scale ranges from 1 to 8, with score 1 on the scale corresponds to an ambulatory patient with minimal symptoms and score 8 on the scale corresponds to death.
measure: Mortality
time frame: 15 days
description: All-cause mortality assessed on day 15.
measure: Mortality
time frame: 28 days
description: All-cause mortality assessed on day 28.
measure: Supplemental Oxygen
time frame: 28 days
description: Supplemental Oxygen-free days
measure: Invasive-ventilator
time frame: 28 days
description: Invasive-ventilator-free days
measure: ICU stay
time frame: 28 days
description: ICU-free days
measure: Hospital stay
time frame: 28 days
description: Hospital-free days
measure: Inflammatory markers
time frame: 15 days
description: Decrease in the markers D-dimer/ Ferritin/ C-reactive protein
measure: Thromboembolic complications
time frame: 28 days
description: Thromboembolic complications including stroke
measure: COVID ordinal scale
time frame: 28 days
description: COVID ordinal scale
arm group label: Participants receiving Dipyridamole and Aspirin
arm group type: Experimental
description: Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally plus standard care. Participants will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally), 2 times daily starting on the day of enrollment for a total of 2 weeks.
arm group label: Participants receiving standard of care
arm group type: Other
description: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
intervention type: Drug
intervention name: Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care
description: Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
arm group label: Participants receiving Dipyridamole and Aspirin
other name: Aggrenox
intervention type: Other
intervention name: Standard of care
description: Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
arm group label: Participants receiving Dipyridamole and Aspirin
arm group label: Participants receiving standard of care
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Amit Singla, MD
role: Principal Investigator
affiliation: Rutgers University
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Amit Singla, MD, FAANS
investigator title: Assistant Professor
mesh term: COVID-19
mesh term: Aspirin
mesh term: Dipyridamole
sharing ipd: No
provided document: 
submitted: June 1, 2022
returned: June 23, 2022
submitted: December 22, 2022
returned: January 19, 2023