xml: <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/NCT05997290</url>
    </required_header>
    <id_info>
      <org_study_id>C4591054</org_study_id>
      <nct_id>NCT05997290</nct_id>
    </id_info>
    <brief_title>A Study to Learn About New COVD-19 RNA Vaccine Candidates for New Varients in Healthy Individuals</brief_title>
    <official_title>A PHASE 2/3 PROTOCOL TO INVESTIGATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED VACCINE CANDIDATES FOR SARS-CoV-2 NEW VARIANTS IN HEALTHY INDIVIDUALS</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BioNTech SE</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Pfizer</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>BioNTech SE</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this clinical protocol is to learn about the safety, tolerability, and&#xD;
        immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of&#xD;
        SARS-CoV-2 in healthy people.&#xD;
  &#xD;
        Substudy A:&#xD;
  &#xD;
          -  This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi&#xD;
             XBB.1.5) given as a single 30 µg dose,&#xD;
  &#xD;
               -  in people who are 12 years of age and older,&#xD;
  &#xD;
               -  who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine,&#xD;
                  with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine&#xD;
                  received at least 150 days before the study vaccination (Visit 1).&#xD;
  &#xD;
          -  The study is about 6 months long for each participant.&#xD;
  &#xD;
          -  Participants will have at least 5 visits to the clinic.&#xD;
  &#xD;
          -  At each clinic visit a blood sample will be taken.&#xD;
  &#xD;
          -  At least 1 nasal swab will taken.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2023</start_date>
    <completion_date type="Anticipated">June 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 28, 2024</primary_completion_date>
    <phase>Phase 2/Phase 3</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>Phase 2/3, controlled study</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>Open-label</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>SSA: Percentage of participants reporting local reactions</measure>
      <time_frame>For up to 7 days following the study vaccination</time_frame>
      <description>Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SSA: Percentage of participants reporting systemic events</measure>
      <time_frame>For up to 7 days following the study vaccination</time_frame>
      <description>Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SSA: Percentage of participants reporting adverse events</measure>
      <time_frame>Through 1 month after the study vaccination</time_frame>
      <description>As elicited by the investigational staff</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SSA: Percentage of participants reporting serious adverse events</measure>
      <time_frame>Through 6 months after the study vaccination</time_frame>
      <description>As elicited by the investigational staff</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg</measure>
      <time_frame>At 1 month after the study vaccination</time_frame>
      <description>As measured at the central laboratory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg</measure>
      <time_frame>From before study vaccination (Day 1) to 1 month after study vaccination</time_frame>
      <description>As measured at the central laboratory</description>
    </primary_outcome>
    <primary_outcome>
      <measure>SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels</measure>
      <time_frame>At 1 month after the study vaccination</time_frame>
      <description>As measured at the central laboratory</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">700</enrollment>
    <condition>SARS-CoV-2 Infection</condition>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>SSA: Group 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>BNT162b2 (Omi XBB.1.5)</intervention_name>
      <description>BNT162b2 monovalent (Omicron XBB.1.5)</description>
      <arm_group_label>SSA: Group 1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          SSA&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the&#xD;
               most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine&#xD;
               received at least 150 days before Visit 1 (Day 1).&#xD;
  &#xD;
            -  12 years of age and older&#xD;
  &#xD;
            -  Healthy participants (stable pre-existing disease permitted).&#xD;
  &#xD;
            -  Willing and able to comply with all scheduled visits/contacts, study procedures and&#xD;
               lifestyle considerations.&#xD;
  &#xD;
            -  Capable of giving, or parent(s)/legal guardian capable of giving, signed informed&#xD;
               consent.&#xD;
  &#xD;
          Exclusion Criteria&#xD;
  &#xD;
            -  History of severe adverse reaction associated with a vaccine and/or severe allergic&#xD;
               reaction (eg, anaphylaxis) to any component of the study vaccines.&#xD;
  &#xD;
            -  Immunocompromised with known or suspected immunodeficiency, as determined by history&#xD;
               and/or laboratory/physical examination.&#xD;
  &#xD;
            -  Bleeding diathesis or condition associated with prolonged bleeding that would, in the&#xD;
               opinion of the investigator, contraindicate intramuscular injection.&#xD;
  &#xD;
            -  Women who are pregnant or breastfeeding.&#xD;
  &#xD;
            -  Any medical or psychiatric condition, or laboratory abnormality that may increase the&#xD;
               risk of study participation or, in the investigator's judgment, make the participant&#xD;
               inappropriate for the study.&#xD;
  &#xD;
            -  History of myocarditis or pericarditis.&#xD;
  &#xD;
            -  Receipt of systemic treatment with known immunosuppressant medications (including&#xD;
               cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune&#xD;
               disease), or radiotherapy, within 60 days before enrollment or planned receipt through&#xD;
               conclusion of the study.&#xD;
  &#xD;
            -  Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, used for&#xD;
               the treatment or prevention of COVID-19 or those that are considered&#xD;
               immunosuppressive, from 60 days before study vaccination or planned receipt throughout&#xD;
               the study.&#xD;
  &#xD;
            -  Participation in other studies involving receipt of other study intervention within 28&#xD;
               days before enrollment. Anticipated participation in other studies involving other&#xD;
               study intervention from enrollment through the end of this study.&#xD;
  &#xD;
            -  Investigator site staff directly involved in the conduct of the study and their family&#xD;
               members, site staff otherwise supervised by the investigator, and sponsor and sponsor&#xD;
               delegate employees directly involved in the conduct of the study and their family&#xD;
               members.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <role>Study Director</role>
      <affiliation>Pfizer</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Pfizer CT.gov Call Center</last_name>
      <phone>1-800-718-1021</phone>
      <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>North Alabama Research Center</name>
        <address>
          <city>Athens</city>
          <state>Alabama</state>
          <zip>35611</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Medical Affiliated Research Center</name>
        <address>
          <city>Huntsville</city>
          <state>Alabama</state>
          <zip>35801</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>Mobile</city>
          <state>Alabama</state>
          <zip>36608</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Epic Medical Research - Surprise</name>
        <address>
          <city>Surprise</city>
          <state>Arizona</state>
          <zip>85378</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>Tempe</city>
          <state>Arizona</state>
          <zip>85281</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>West Coast Research</name>
        <address>
          <city>Dublin</city>
          <state>California</state>
          <zip>94568</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>California Research Foundation</name>
        <address>
          <city>San Diego</city>
          <state>California</state>
          <zip>92123</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Bayview Research Group, LLC</name>
        <address>
          <city>Valley Village</city>
          <state>California</state>
          <zip>91607</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Diablo Clinical Research, Inc.</name>
        <address>
          <city>Walnut Creek</city>
          <state>California</state>
          <zip>94598</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Consulting</name>
        <address>
          <city>Milford</city>
          <state>Connecticut</state>
          <zip>06460</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Indago Research &amp; Health Center, Inc</name>
        <address>
          <city>Hialeah</city>
          <state>Florida</state>
          <zip>33012</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Neuroscience Solutions, Inc. dba CNS Healthcare</name>
        <address>
          <city>Jacksonville</city>
          <state>Florida</state>
          <zip>32256</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Acevedo Clinical Research Associates</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33142</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Neuroscience Solutions, Inc.</name>
        <address>
          <city>Orlando</city>
          <state>Florida</state>
          <zip>32801</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Research Atlanta</name>
        <address>
          <city>Stockbridge</city>
          <state>Georgia</state>
          <zip>30281</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>East-West Medical Research Institute</name>
        <address>
          <city>Honolulu</city>
          <state>Hawaii</state>
          <zip>96814</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Kentucky Pediatric/ Adult Research</name>
        <address>
          <city>Bardstown</city>
          <state>Kentucky</state>
          <zip>40004</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Bio-Kinetic Clinical Applications, LLD dba QPS-MO</name>
        <address>
          <city>Springfield</city>
          <state>Missouri</state>
          <zip>65802</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>M3 Wake Research, Inc.</name>
        <address>
          <city>Raleigh</city>
          <state>North Carolina</state>
          <zip>27612</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Centricity Research Columbus Ohio Multispecialty</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Dayton Clinical Research</name>
        <address>
          <city>Dayton</city>
          <state>Ohio</state>
          <zip>45409</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Senders Pediatrics</name>
        <address>
          <city>South Euclid</city>
          <state>Ohio</state>
          <zip>44121</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Epic Medical Research-Oklahoma</name>
        <address>
          <city>Chickasha</city>
          <state>Oklahoma</state>
          <zip>73018</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>Knoxville</city>
          <state>Tennessee</state>
          <zip>37909</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>Clinical Neuroscience Solutions Inc.</name>
        <address>
          <city>Memphis</city>
          <state>Tennessee</state>
          <zip>38119</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Epic Medical Research - DeSoto</name>
        <address>
          <city>DeSoto</city>
          <state>Texas</state>
          <zip>75115</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research - Bellaire</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77081</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>IMA Clinical Research San Antonio</name>
        <address>
          <city>San Antonio</city>
          <state>Texas</state>
          <zip>78229</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>DM Clinical Research</name>
        <address>
          <city>Tomball</city>
          <state>Texas</state>
          <zip>77375</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>Layton</city>
          <state>Utah</state>
          <zip>84041</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location>
      <facility>
        <name>J. Lewis Research, Inc. / Foothill Family Clinic</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84109</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>J. Lewis Research, Inc. / Foothill Family Clinic South</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84121</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location>
      <facility>
        <name>Alliance for Multispecialty Research, LLC</name>
        <address>
          <city>Norfolk</city>
          <state>Virginia</state>
          <zip>23502</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>https://pmiform.com/clinical-trial-info-request?StudyID=C4591054</url>
      <description>To obtain contact information for a study center near you, click here.</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 10, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>Coronavirus</keyword>
    <keyword>Vaccine</keyword>
    <keyword>SARS-CoV-2</keyword>
    <keyword>RNA Vaccine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997290
  org study id: C4591054
  nct id: NCT05997290
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of this clinical protocol is to learn about the safety, tolerability, and
        immunogenicity of new BNT162b2 RNA-based vaccine candidates targeting new variants of
        SARS-CoV-2 in healthy people.
  
        Substudy A:
  
          -  This study will evaluate the safety, tolerability, and immunogenicity of BNT162b2 (Omi
             XBB.1.5) given as a single 30 µg dose,
  
               -  in people who are 12 years of age and older,
  
               -  who previously received at least 3 doses of a US-authorized mRNA COVID-19 vaccine,
                  with the most recent dose being an Omicron BA.4/BA.5-adapted bivalent vaccine
                  received at least 150 days before the study vaccination (Visit 1).
  
          -  The study is about 6 months long for each participant.
  
          -  Participants will have at least 5 visits to the clinic.
  
          -  At each clinic visit a blood sample will be taken.
  
          -  At least 1 nasal swab will taken.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Phase 2/3, controlled study
  primary purpose: Prevention
  masking: None (Open Label)
  masking description: Open-label
  measure: SSA: Percentage of participants reporting local reactions
  time frame: For up to 7 days following the study vaccination
  description: Pain at the injection site, redness, and swelling, as self-reported in electronic diaries.
  measure: SSA: Percentage of participants reporting systemic events
  time frame: For up to 7 days following the study vaccination
  description: Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain, as self-reported in electronic diaries
  measure: SSA: Percentage of participants reporting adverse events
  time frame: Through 1 month after the study vaccination
  description: As elicited by the investigational staff
  measure: SSA: Percentage of participants reporting serious adverse events
  time frame: Through 6 months after the study vaccination
  description: As elicited by the investigational staff
  measure: SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
  time frame: At 1 month after the study vaccination
  description: As measured at the central laboratory
  measure: SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
  time frame: From before study vaccination (Day 1) to 1 month after study vaccination
  description: As measured at the central laboratory
  measure: SSA: Percentages of participants with seroresponse to BNT162b2 (Omi XBB.1.5) 30 µg in terms of GMTs of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels
  time frame: At 1 month after the study vaccination
  description: As measured at the central laboratory
  arm group label: SSA: Group 1
  arm group type: Experimental
  description: Participants 12 years of age and older will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
  intervention type: Biological
  intervention name: BNT162b2 (Omi XBB.1.5)
  description: BNT162b2 monovalent (Omicron XBB.1.5)
  arm group label: SSA: Group 1
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Pfizer CT.gov Call Center
  role: Study Director
  affiliation: Pfizer
  last name: Pfizer CT.gov Call Center
  phone: 1-800-718-1021
  email: ClinicalTrials.gov_Inquiries@pfizer.com
  facility: 
  status: Not yet recruiting
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  status: Recruiting
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  status: Recruiting
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  status: Not yet recruiting
  country: United States
  url: https://pmiform.com/clinical-trial-info-request?StudyID=C4591054
  description: To obtain contact information for a study center near you, click here.
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No