<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/NCT03305341</url>
  </required_header>
  <id_info>
    <org_study_id>IND153210</org_study_id>
    <secondary_id>FWA00015357</secondary_id>
    <secondary_id>IRB00009424</secondary_id>
    <secondary_id>IORG0007849</secondary_id>
    <secondary_id>IND153210</secondary_id>
    <secondary_id>NDA215451</secondary_id>
    <secondary_id>BLA761218</secondary_id>
    <nct_id>NCT03305341</nct_id>
  </id_info>
  <brief_title>Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics</brief_title>
  <acronym>COV19-APTP-B</acronym>
  <official_title>Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>PPD</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medicine Invention Design, Inc</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic&#xD;
      biologics activity (proof-of-concept) that suggests the potential for clinical benefit of&#xD;
      COVID-19 patients.&#xD;
&#xD;
        1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.&#xD;
&#xD;
        2. Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen.&#xD;
&#xD;
        3. The human antigen presenting cells (APCs) can take up and process COVID-19 target&#xD;
           antigen protein into small peptide fragments, and then COVID-19 virus can be killed by&#xD;
           APCs directly.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Conducting an initial small, controlled trial to assess for therapeutic biologics&#xD;
           activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19&#xD;
           patients.&#xD;
&#xD;
        -  20 Moderate COVID-19 patients&#xD;
&#xD;
        -  Moderate COVID-19&#xD;
&#xD;
        -  Positive testing by standard RT-PCR assay or equivalent testing&#xD;
&#xD;
        -  Symptoms of moderate illness with COVID-19, which could include any symptom of mild&#xD;
           illness or shortness of breath with exertion&#xD;
&#xD;
        -  Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥&#xD;
           20 breaths per minute, saturation of oxygen (SpO2) &gt; 93% on room air at sea level, heart&#xD;
           rate ≥ 90 beats per minute&#xD;
&#xD;
        -  No clinical signs indicative of Severe or Critical Illness Severity&#xD;
&#xD;
        -  Our trial duration will be 4-week duration.&#xD;
&#xD;
        -  0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection&#xD;
&#xD;
        -  Intradermic Injection, ID&#xD;
&#xD;
        -  Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection&#xD;
           2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 18, 2020</start_date>
  <completion_date type="Anticipated">July 28, 2024</completion_date>
  <primary_completion_date type="Anticipated">July 28, 2024</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single Usage / Single Dosage</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open Label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Moderate COVID-19:</measure>
    <time_frame>Duration at least 28 days</time_frame>
    <description>20 Moderate COVID-19 patients&#xD;
Moderate COVID-19&#xD;
Positive testing by standard RT-PCR assay&#xD;
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion&#xD;
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) &gt; 93% on room air at sea level, heart rate ≥ 90 beats per minute&#xD;
No clinical signs indicative of Severe or Critical Illness Severity</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Positive COVID-19 nucleic acid:</measure>
    <time_frame>Duration at least 28 days</time_frame>
    <description>20 Moderate COVID-19 patients&#xD;
Positive testing COVID-19 by standard RT-PCR assay immediately&#xD;
COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit&#xD;
Rate of Positive COVID-19 nucleic acid must be 100%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concentration of Active Ingredient:</measure>
    <time_frame>Duration at least 28 days</time_frame>
    <description>0.1mg COVID-19 Spike-GM-CSF Protein&#xD;
0.5 ml Lactated Ringer's Injection, USP&#xD;
0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rate of Negative COVID-19 nucleic acid</measure>
    <time_frame>Duration at least 28 days</time_frame>
    <description>20 Moderate COVID-19 patients&#xD;
0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection&#xD;
Intradermic Injection, ID&#xD;
Negative COVID-19 by standard RT-PCR assay after injection 2 weeks&#xD;
COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit&#xD;
Rate of Negative COVID-19 nucleic acid will be more than 80%</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Covid19</condition>
  <arm_group>
    <arm_group_label>Assess for therapeutic biologics activity (proof-of-concept)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.1mg Spike-GM-CSF Protein&#xD;
0.5 ml Lactated Ringer's Injection, USP</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection</intervention_name>
    <description>Intradermic Injection, ID&#xD;
COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection</description>
    <arm_group_label>Assess for therapeutic biologics activity (proof-of-concept)</arm_group_label>
    <other_name>COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Conducting an initial small, controlled trial to assess for therapeutic biologics&#xD;
             activity (proof-of-concept) that suggests the potential for clinical benefit of&#xD;
             COVID-19 patients.&#xD;
&#xD;
          -  20 Moderate COVID-19 patients&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Moderate COVID-19&#xD;
&#xD;
          -  Positive testing by standard RT-PCR assay or equivalent testing&#xD;
&#xD;
          -  Symptoms of moderate illness with COVID-19, which could include any symptom of mild&#xD;
             illness or shortness of breath with exertion&#xD;
&#xD;
          -  Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate&#xD;
             ≥ 20 breaths per minute, saturation of oxygen (SpO2) &gt; 93% on room air at sea level,&#xD;
             heart rate ≥ 90 beats per minute&#xD;
&#xD;
          -  No clinical signs indicative of Severe or Critical Illness Severity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. Severe or Critical Illness Severity&#xD;
&#xD;
          -  2. Pregnancy&#xD;
&#xD;
          -  3. Breast-feeding&#xD;
&#xD;
          -  4. The patients with other serious inter-current illness&#xD;
&#xD;
          -  5. Serious Allergy&#xD;
&#xD;
          -  6. Serious Bleed Tendency&#xD;
&#xD;
          -  7. The prohibition of the biological product&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HAN XU, M.D., Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Medicine Invention Design, Inc. (MIDI) - IORG0007849</affiliation>
  </overall_official>
  <overall_official>
    <last_name>HAN XU, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Medicine Invention Design, Inc. (MIDI) - IORG0007849</affiliation>
  </overall_official>
  <overall_official>
    <last_name>HAN XU, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medicine Invention Design, Inc. (MIDI) - IORG0007849</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medicine Invention Design Incorporation (MIDI) - IORG0007849</name>
      <address>
        <city>North Bethesda</city>
        <state>Maryland</state>
        <zip>20852</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://ohrp.cit.nih.gov/search</url>
    <description>FWA00015357</description>
  </link>
  <link>
    <url>http://ohrp.cit.nih.gov/search</url>
    <description>IRB00009424</description>
  </link>
  <link>
    <url>http://ohrp.cit.nih.gov/search</url>
    <description>IORG0007849</description>
  </link>
  <reference>
    <citation>Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.</citation>
    <PMID>27102489</PMID>
  </reference>
  <reference>
    <citation>Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.</citation>
    <PMID>32132681</PMID>
  </reference>
  <reference>
    <citation>Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.</citation>
    <PMID>30619296</PMID>
  </reference>
  <reference>
    <citation>Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.</citation>
    <PMID>32660100</PMID>
  </reference>
  <reference>
    <citation>Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2.</citation>
    <PMID>32877576</PMID>
  </reference>
  <reference>
    <citation>Wollina U. Challenges of COVID-19 pandemic for dermatology. Dermatol Ther. 2020 Sep;33(5):e13430. doi: 10.1111/dth.13430. Epub 2020 Apr 30.</citation>
    <PMID>32314460</PMID>
  </reference>
  <reference>
    <citation>Catala Gonzalo A, Galvan Casas C. COVID-19 and the Skin. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):447-449. doi: 10.1016/j.ad.2020.04.007. Epub 2020 May 13. No abstract available. English, Spanish.</citation>
    <PMID>32401723</PMID>
  </reference>
  <reference>
    <citation>Guarneri C, Rullo EV, Pavone P, Berretta M, Ceccarelli M, Natale A, Nunnari G. Silent COVID-19: what your skin can reveal. Lancet Infect Dis. 2021 Jan;21(1):24-25. doi: 10.1016/S1473-3099(20)30402-3. Epub 2020 May 18. No abstract available.</citation>
    <PMID>32437697</PMID>
  </reference>
  <reference>
    <citation>Freeman EE, McMahon DE, Lipoff JB, Rosenbach M, Kovarik C, Takeshita J, French LE, Thiers BH, Hruza GJ, Fox LP; American Academy of Dermatology Ad Hoc Task Force on COVID-19. Pernio-like skin lesions associated with COVID-19: A case series of 318 patients from 8 countries. J Am Acad Dermatol. 2020 Aug;83(2):486-492. doi: 10.1016/j.jaad.2020.05.109. Epub 2020 May 30.</citation>
    <PMID>32479979</PMID>
  </reference>
  <reference>
    <citation>Klejtman T. Skin and COVID-19. J Med Vasc. 2020 Jul;45(4):175-176. doi: 10.1016/j.jdmv.2020.06.001. No abstract available.</citation>
    <PMID>32571556</PMID>
  </reference>
  <reference>
    <citation>Gul U. COVID-19 and dermatology. Turk J Med Sci. 2020 Dec 17;50(8):1751-1759. doi: 10.3906/sag-2005-182.</citation>
    <PMID>32599968</PMID>
  </reference>
  <reference>
    <citation>Gottlieb M, Long B. Dermatologic manifestations and complications of COVID-19. Am J Emerg Med. 2020 Sep;38(9):1715-1721. doi: 10.1016/j.ajem.2020.06.011. Epub 2020 Jun 6.</citation>
    <PMID>32731141</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>October 4, 2017</study_first_submitted>
  <study_first_submitted_qc>October 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>March 13, 2023</last_update_submitted>
  <last_update_submitted_qc>March 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Medicine Invention Design, Inc</investigator_affiliation>
    <investigator_full_name>Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair</investigator_full_name>
    <investigator_title>M.D., Ph.D., Sponsor-Investigator, IORG Director, Monitor, IRB Chair</investigator_title>
  </responsible_party>
  <keyword>Gene Mutation</keyword>
  <keyword>Antigen Presentation</keyword>
  <keyword>APC</keyword>
  <keyword>Spike</keyword>
  <keyword>COVID-19</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>Molgramostim</mesh_term>
    <mesh_term>Sargramostim</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03305341
org study id: IND153210
secondary id: FWA00015357
secondary id: IRB00009424
secondary id: IORG0007849
secondary id: IND153210
secondary id: NDA215451
secondary id: BLA761218
nct id: NCT03305341
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Conducting an initial small, controlled clinical pharmacology trial to assess for therapeutic
      biologics activity (proof-of-concept) that suggests the potential for clinical benefit of
      COVID-19 patients.

        1. Treat Infection of Multiple Gene Mutation COVID-19 Virus Strains.

        2. Activate Human Antigen Presentation Reaction to COVID-19 Specific Antigen.

        3. The human antigen presenting cells (APCs) can take up and process COVID-19 target
           antigen protein into small peptide fragments, and then COVID-19 virus can be killed by
           APCs directly.
-  Conducting an initial small, controlled trial to assess for therapeutic biologics
           activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19
           patients.

        -  20 Moderate COVID-19 patients

        -  Moderate COVID-19

        -  Positive testing by standard RT-PCR assay or equivalent testing

        -  Symptoms of moderate illness with COVID-19, which could include any symptom of mild
           illness or shortness of breath with exertion

        -  Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥
           20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart
           rate ≥ 90 beats per minute

        -  No clinical signs indicative of Severe or Critical Illness Severity

        -  Our trial duration will be 4-week duration.

        -  0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection

        -  Intradermic Injection, ID

        -  Negative testing COVID-19 by standard RT-PCR assay or equivalent testing after injection
           2 weeks.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single Usage / Single Dosage
primary purpose: Treatment
masking: None (Open Label)
masking description: Open Label
measure: Number of Participants with Moderate COVID-19:
time frame: Duration at least 28 days
description: 20 Moderate COVID-19 patients
Moderate COVID-19
Positive testing by standard RT-PCR assay
Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
No clinical signs indicative of Severe or Critical Illness Severity
measure: Rate of Positive COVID-19 nucleic acid:
time frame: Duration at least 28 days
description: 20 Moderate COVID-19 patients
Positive testing COVID-19 by standard RT-PCR assay immediately
COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit
Rate of Positive COVID-19 nucleic acid must be 100%
measure: Concentration of Active Ingredient:
time frame: Duration at least 28 days
description: 0.1mg COVID-19 Spike-GM-CSF Protein
0.5 ml Lactated Ringer's Injection, USP
0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
measure: Rate of Negative COVID-19 nucleic acid
time frame: Duration at least 28 days
description: 20 Moderate COVID-19 patients
0.1mg / 0.5 ml COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
Intradermic Injection, ID
Negative COVID-19 by standard RT-PCR assay after injection 2 weeks
COVID-19 nucleic acid testing, assessed by RT-PCR Assay Kit
Rate of Negative COVID-19 nucleic acid will be more than 80%
arm group label: Assess for therapeutic biologics activity (proof-of-concept)
arm group type: Experimental
description: 0.1mg Spike-GM-CSF Protein
0.5 ml Lactated Ringer's Injection, USP
intervention type: Biological
intervention name: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection
description: Intradermic Injection, ID
COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
arm group label: Assess for therapeutic biologics activity (proof-of-concept)
other name: COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection
criteria: 
gender: All
minimum age: 22 Years
maximum age: 72 Years
healthy volunteers: No
last name: HAN XU, M.D., Ph.D.
role: Study Chair
affiliation: Medicine Invention Design, Inc. (MIDI) - IORG0007849
last name: HAN XU, M.D., Ph.D.
role: Study Director
affiliation: Medicine Invention Design, Inc. (MIDI) - IORG0007849
last name: HAN XU, M.D., Ph.D.
role: Principal Investigator
affiliation: Medicine Invention Design, Inc. (MIDI) - IORG0007849
facility: 
country: United States
url: http://ohrp.cit.nih.gov/search
description: FWA00015357
url: http://ohrp.cit.nih.gov/search
description: IRB00009424
url: http://ohrp.cit.nih.gov/search
description: IORG0007849
citation: Netea MG, Joosten LA, Latz E, Mills KH, Natoli G, Stunnenberg HG, O'Neill LA, Xavier RJ. Trained immunity: A program of innate immune memory in health and disease. Science. 2016 Apr 22;352(6284):aaf1098. doi: 10.1126/science.aaf1098. Epub 2016 Apr 21.
PMID: 27102489
citation: Netea MG, Dominguez-Andres J, Barreiro LB, Chavakis T, Divangahi M, Fuchs E, Joosten LAB, van der Meer JWM, Mhlanga MM, Mulder WJM, Riksen NP, Schlitzer A, Schultze JL, Stabell Benn C, Sun JC, Xavier RJ, Latz E. Defining trained immunity and its role in health and disease. Nat Rev Immunol. 2020 Jun;20(6):375-388. doi: 10.1038/s41577-020-0285-6. Epub 2020 Mar 4.
PMID: 32132681
citation: Sanchez-Ramon S, Conejero L, Netea MG, Sancho D, Palomares O, Subiza JL. Trained Immunity-Based Vaccines: A New Paradigm for the Development of Broad-Spectrum Anti-infectious Formulations. Front Immunol. 2018 Dec 17;9:2936. doi: 10.3389/fimmu.2018.02936. eCollection 2018.
PMID: 30619296
citation: Guevara-Hoyer K, Saz-Leal P, Diez-Rivero CM, Ochoa-Grullon J, Fernandez-Arquero M, Perez de Diego R, Sanchez-Ramon S. Trained Immunity Based-Vaccines as a Prophylactic Strategy in Common Variable Immunodeficiency. A Proof of Concept Study. Biomedicines. 2020 Jul 9;8(7):203. doi: 10.3390/biomedicines8070203.
PMID: 32660100
citation: Keech C, Albert G, Cho I, Robertson A, Reed P, Neal S, Plested JS, Zhu M, Cloney-Clark S, Zhou H, Smith G, Patel N, Frieman MB, Haupt RE, Logue J, McGrath M, Weston S, Piedra PA, Desai C, Callahan K, Lewis M, Price-Abbott P, Formica N, Shinde V, Fries L, Lickliter JD, Griffin P, Wilkinson B, Glenn GM. Phase 1-2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine. N Engl J Med. 2020 Dec 10;383(24):2320-2332. doi: 10.1056/NEJMoa2026920. Epub 2020 Sep 2.
PMID: 32877576
citation: Wollina U. Challenges of COVID-19 pandemic for dermatology. Dermatol Ther. 2020 Sep;33(5):e13430. doi: 10.1111/dth.13430. Epub 2020 Apr 30.
PMID: 32314460
citation: Catala Gonzalo A, Galvan Casas C. COVID-19 and the Skin. Actas Dermosifiliogr (Engl Ed). 2020 Jul-Aug;111(6):447-449. doi: 10.1016/j.ad.2020.04.007. Epub 2020 May 13. No abstract available. English, Spanish.
PMID: 32401723
citation: Guarneri C, Rullo EV, Pavone P, Berretta M, Ceccarelli M, Natale A, Nunnari G. Silent COVID-19: what your skin can reveal. Lancet Infect Dis. 2021 Jan;21(1):24-25. doi: 10.1016/S1473-3099(20)30402-3. Epub 2020 May 18. No abstract available.
PMID: 32437697
citation: Freeman EE, McMahon DE, Lipoff JB, Rosenbach M, Kovarik C, Takeshita J, French LE, Thiers BH, Hruza GJ, Fox LP; American Academy of Dermatology Ad Hoc Task Force on COVID-19. Pernio-like skin lesions associated with COVID-19: A case series of 318 patients from 8 countries. J Am Acad Dermatol. 2020 Aug;83(2):486-492. doi: 10.1016/j.jaad.2020.05.109. Epub 2020 May 30.
PMID: 32479979
citation: Klejtman T. Skin and COVID-19. J Med Vasc. 2020 Jul;45(4):175-176. doi: 10.1016/j.jdmv.2020.06.001. No abstract available.
PMID: 32571556
citation: Gul U. COVID-19 and dermatology. Turk J Med Sci. 2020 Dec 17;50(8):1751-1759. doi: 10.3906/sag-2005-182.
PMID: 32599968
citation: Gottlieb M, Long B. Dermatologic manifestations and complications of COVID-19. Am J Emerg Med. 2020 Sep;38(9):1715-1721. doi: 10.1016/j.ajem.2020.06.011. Epub 2020 Jun 6.
PMID: 32731141
responsible party type: Sponsor-Investigator
investigator affiliation: Medicine Invention Design, Inc
investigator full name: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
investigator title: M.D., Ph.D., Sponsor-Investigator, IORG Director, Monitor, IRB Chair
mesh term: COVID-19
mesh term: Molgramostim
mesh term: Sargramostim
sharing ipd: No