<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/NCT04409886</url>
  </required_header>
  <id_info>
    <org_study_id>120-20-ASF</org_study_id>
    <nct_id>NCT04409886</nct_id>
  </id_info>
  <brief_title>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients</brief_title>
  <acronym>HBOT</acronym>
  <official_title>The Application of Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients - Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maimonides Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maimonides Medical Center</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>
      This study is a prospective randomized controlled, double blind clinical trial performed on&#xD;
      laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The&#xD;
      trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or&#xD;
      Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the&#xD;
      standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and&#xD;
      others.&#xD;
&#xD;
      The evaluation procedure includes symptom monitoring, room air saturation, vital signs&#xD;
      monitoring, pulmonary function and blood tests at baseline, one day and one week after the&#xD;
      last session. In addition, one hour prior to and post session saturation and vitals will be&#xD;
      monitored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospective randomized controlled, double blind clinical trial performed on&#xD;
      laboratory confirmed COVID-19 infection admitted patients at MMC. The trial will include 30&#xD;
      patients who will undergo either HBOT or NBOT, randomized on a 2:1 ratio, within 4 days in&#xD;
      addition to the standard treatment including oxygen, drugs, steroids, bronchodilators,&#xD;
      antibiotics and others.&#xD;
&#xD;
      Sessions will be provided in an MMC monoplace HBO chamber (RestorixHealth). Since all&#xD;
      patients demand oxygen supply at room air, the control group is an active arm receiving 100%&#xD;
      oxygen. For HBOT, each session will include breathing 100% oxygen at 2.2 absolute atmospheres&#xD;
      (ATA) for 60 minutes. Compression and decompression will occur at 1 meter/minute rate. For&#xD;
      NBOT, each session will include breathing 100% oxygen at 1.0 absolute atmospheres (ATA) for&#xD;
      60 minutes. In order to blind the patient, the first 5 minutes will include compression for&#xD;
      1.1 ATA and then decompression to 1.0 within the next 5 minutes.&#xD;
&#xD;
      During the sessions, the symptoms and vitals will be monitored. The evaluation procedure will&#xD;
      include symptom monitoring, room air saturation, vital signs monitoring, pulmonary function&#xD;
      and blood tests at baseline, one day and one week after the last session. In addition, one&#xD;
      hour prior to and post session saturation and vitals will be monitored. Sessions and&#xD;
      evaluations procedures will occur as the following:&#xD;
&#xD;
      Protocol Day 1&#xD;
&#xD;
        1. Baseline evaluation: blood test including: arterial blood gases, 2 CBC tubes, 2 Gel&#xD;
           tubes (10-15 cc total), vitals (temperature, blood pressure, heart rate, room air&#xD;
           saturation), symptoms questionnaire, pulmonary function test.&#xD;
&#xD;
        2. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to&#xD;
           session&#xD;
&#xD;
        3. One-hour session NBO/HBO&#xD;
&#xD;
        4. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the&#xD;
           session.&#xD;
&#xD;
        5. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the&#xD;
           2nd session.&#xD;
&#xD;
        6. One-hour session NBO/HBO (8 hours following the first session)&#xD;
&#xD;
        7. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the&#xD;
           session.&#xD;
&#xD;
        8. Daily oxygen supply dose monitoring. Protocol Day 2-4&#xD;
&#xD;
      1. Daily symptoms questionnaire 2. Vitals (temperature, blood pressure, heartrate, room air&#xD;
      saturation) one hour prior to session One-hour session NBO/HBO 3. Vitals (temperature, blood&#xD;
      pressure, heartrate, room air saturation) one hour after the session.&#xD;
&#xD;
      4. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the&#xD;
      2nd session.&#xD;
&#xD;
      5. One-hour session NBO/HBO (8 hours following the first session) 6. Vitals (temperature,&#xD;
      blood pressure, heartrate, room air saturation) one hour after the session.&#xD;
&#xD;
      7. Daily oxygen supply dose monitoring. Follow up Protocol&#xD;
&#xD;
        1. Repeat evaluations one day after the last session and one week after the last session:&#xD;
&#xD;
             -  Blood test including: arterial blood gases, 2 CBC tubes, 2 Gel tubes (10-15 cc&#xD;
                total)&#xD;
&#xD;
             -  Vitals (temperature, blood pressure, heart rate, room air saturation)&#xD;
&#xD;
             -  Symptoms questionnaire&#xD;
&#xD;
             -  Pulmonary function test.&#xD;
&#xD;
        2. Oropharyngeal swab for SARS-CoV-2 RT-PCR every 3 days for 1 week&#xD;
&#xD;
        3. Clinical monitoring for 30 days&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    This study is part of a larger national study. Only 1 patient was enrolled at Maimonides;&#xD;
    Medical Center. The study was ended by the sponsor because the PI left; funding ended; , and no&#xD;
    time, or personnel to do the study&#xD;
  </why_stopped>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Actual">January 31, 2021</completion_date>
  <primary_completion_date type="Actual">January 31, 2021</primary_completion_date>
  <phase>Phase 4</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygenation Index</measure>
    <time_frame>one day after the last session</time_frame>
    <description>PaO2/FiO2 (Oxygenation Index)</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">1</enrollment>
  <condition>COVID, Coronavirus</condition>
  <arm_group>
    <arm_group_label>HBOT (Hyperbaric Oxygen Therapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Hyperbaric Oxygen Therapy</intervention_name>
    <description>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)</description>
    <arm_group_label>HBOT (Hyperbaric Oxygen Therapy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Within 7 days of patient's need of oxygen supply&#xD;
&#xD;
          -  Positive SARS-CoV-2 RT-PCR&#xD;
&#xD;
          -  At least one risk factor for bad prognosis of COVID-19: hypertension, diabetes&#xD;
             mellitus, ischemic heart disease, smoking, age&gt;50, etc.&#xD;
&#xD;
          -  Respiratory insufficiency: Room Air SpO2 &lt;94% or PaO2/FiO2&lt;300mmHg&#xD;
&#xD;
          -  Age&gt;18&#xD;
&#xD;
          -  Ability to sign an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Negative SARS-CoV-2 RT-PCR&#xD;
&#xD;
          -  HBOT contraindication: pneumothorax, pneumomediastinum, claustrophobia, ear/sinus&#xD;
             disease which aren't allowed in HBOT, known chronic pulmonary disease: severe&#xD;
             emphysema or known pulmonary bullae.&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Inability to sign an informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ory Wiesel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maimonides Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Maimonides Medical Center</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <results_first_submitted>May 25, 2021</results_first_submitted>
  <results_first_submitted_qc>June 25, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">June 29, 2021</results_first_posted>
  <last_update_submitted>June 25, 2021</last_update_submitted>
  <last_update_submitted_qc>June 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will not be shared</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/86/NCT04409886/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>HBOT (Hyperbaric Oxygen Therapy)</title>
          <description>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)&#xD;
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>HBOT (Hyperbaric Oxygen Therapy)</title>
          <description>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)&#xD;
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Oxygenation Index</title>
        <description>PaO2/FiO2 (Oxygenation Index)</description>
        <time_frame>one day after the last session</time_frame>
        <population>PI left institution and the study was terminated with only 1 participant enrolled. No data available to report</population>
        <group_list>
          <group group_id="O1">
            <title>HBOT (Hyperbaric Oxygen Therapy)</title>
            <description>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)&#xD;
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)</description>
          </group>
        </group_list>
        <measure>
          <title>Oxygenation Index</title>
          <description>PaO2/FiO2 (Oxygenation Index)</description>
          <population>PI left institution and the study was terminated with only 1 participant enrolled. No data available to report</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>30 days</time_frame>
      <desc>Adverse events includes adverse events that result in any of the following outcomes: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions</desc>
      <group_list>
        <group group_id="E1">
          <title>HBOT (Hyperbaric Oxygen Therapy)</title>
          <description>Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)&#xD;
Hyperbaric Oxygen Therapy: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="1"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Gene Sobol</name_or_title>
      <organization>Maimonides Medical Center</organization>
      <phone>718-283-6000</phone>
      <email>gsobol@maimonidesmed.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04409886
org study id: 120-20-ASF
nct id: NCT04409886
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This study is a prospective randomized controlled, double blind clinical trial performed on
      laboratory confirmed COVID-19 infection admitted patients in the Shamir Medical Center. The
      trial will include 30 patients who will undergo either hyperbaric oxygen therapy (HBOT) or
      Normobaric oxygen therapy (NBOT), randomized on a 2:1 ratio, within 4 days in addition to the
      standard treatment including oxygen, drugs, steroids, bronchodilators, antibiotics and
      others.

      The evaluation procedure includes symptom monitoring, room air saturation, vital signs
      monitoring, pulmonary function and blood tests at baseline, one day and one week after the
      last session. In addition, one hour prior to and post session saturation and vitals will be
      monitored.
This study is a prospective randomized controlled, double blind clinical trial performed on
      laboratory confirmed COVID-19 infection admitted patients at MMC. The trial will include 30
      patients who will undergo either HBOT or NBOT, randomized on a 2:1 ratio, within 4 days in
      addition to the standard treatment including oxygen, drugs, steroids, bronchodilators,
      antibiotics and others.

      Sessions will be provided in an MMC monoplace HBO chamber (RestorixHealth). Since all
      patients demand oxygen supply at room air, the control group is an active arm receiving 100%
      oxygen. For HBOT, each session will include breathing 100% oxygen at 2.2 absolute atmospheres
      (ATA) for 60 minutes. Compression and decompression will occur at 1 meter/minute rate. For
      NBOT, each session will include breathing 100% oxygen at 1.0 absolute atmospheres (ATA) for
      60 minutes. In order to blind the patient, the first 5 minutes will include compression for
      1.1 ATA and then decompression to 1.0 within the next 5 minutes.

      During the sessions, the symptoms and vitals will be monitored. The evaluation procedure will
      include symptom monitoring, room air saturation, vital signs monitoring, pulmonary function
      and blood tests at baseline, one day and one week after the last session. In addition, one
      hour prior to and post session saturation and vitals will be monitored. Sessions and
      evaluations procedures will occur as the following:

      Protocol Day 1

        1. Baseline evaluation: blood test including: arterial blood gases, 2 CBC tubes, 2 Gel
           tubes (10-15 cc total), vitals (temperature, blood pressure, heart rate, room air
           saturation), symptoms questionnaire, pulmonary function test.

        2. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour prior to
           session

        3. One-hour session NBO/HBO

        4. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the
           session.

        5. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the
           2nd session.

        6. One-hour session NBO/HBO (8 hours following the first session)

        7. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour after the
           session.

        8. Daily oxygen supply dose monitoring. Protocol Day 2-4

      1. Daily symptoms questionnaire 2. Vitals (temperature, blood pressure, heartrate, room air
      saturation) one hour prior to session One-hour session NBO/HBO 3. Vitals (temperature, blood
      pressure, heartrate, room air saturation) one hour after the session.

      4. Vitals (temperature, blood pressure, heartrate, room air saturation) one hour before the
      2nd session.

      5. One-hour session NBO/HBO (8 hours following the first session) 6. Vitals (temperature,
      blood pressure, heartrate, room air saturation) one hour after the session.

      7. Daily oxygen supply dose monitoring. Follow up Protocol

        1. Repeat evaluations one day after the last session and one week after the last session:

             -  Blood test including: arterial blood gases, 2 CBC tubes, 2 Gel tubes (10-15 cc
                total)

             -  Vitals (temperature, blood pressure, heart rate, room air saturation)

             -  Symptoms questionnaire

             -  Pulmonary function test.

        2. Oropharyngeal swab for SARS-CoV-2 RT-PCR every 3 days for 1 week

        3. Clinical monitoring for 30 days
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Oxygenation Index
time frame: one day after the last session
description: PaO2/FiO2 (Oxygenation Index)
arm group label: HBOT (Hyperbaric Oxygen Therapy)
arm group type: Experimental
description: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)
intervention type: Biological
intervention name: Hyperbaric Oxygen Therapy
description: Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)
arm group label: HBOT (Hyperbaric Oxygen Therapy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ory Wiesel, MD
role: Principal Investigator
affiliation: Maimonides Medical Center
facility: 
country: United States
responsible party type: Sponsor
mesh term: Coronavirus Infections
sharing ipd: No
ipd description: Data will not be shared
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 