Evidence Based Medicine on FHIR Implementation Guide
1.0.0-ballot3 - STU 1 Ballot 3 World

Evidence Based Medicine on FHIR Implementation Guide, published by HL7 International / Clinical Decision Support. This guide is not an authorized publication; it is the continuous build for version 1.0.0-ballot3 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/ebm/ and changes regularly. See the Directory of published versions

: NCT04401202 Eligibility Criteria

Page standards status: Informative

Raw json | Download

{
  "resourceType" : "Group",
  "id" : "189713",
  "meta" : {
    "versionId" : "3",
    "lastUpdated" : "2026-08-05T07:33:36.353Z"
  },
  "language" : "en",
  "text" : {
    "status" : "extensions",
    "div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\">\n  <table class=\"narrative-table\">\n    <tbody>\n<tr>\n\n\n<th colspan=\"2\" scope=\"row\" class=\"row-header\"><a name=\"metadata\"> </a>Metadata</th>\n\n\n</tr>\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Title</th>\n\n\n\n<td class=\"content-container\">NCT04401202 Eligibility Criteria</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n  \n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Identifier</th>\n\n\n\n<td class=\"content-container\">189713</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Steward (Publisher)</th>\n\n\n\n<td class=\"content-container\">Computable Publishing LLC</td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Description</th>\n\n\n\n<td class=\"content-container\"><div><p>Inclusion Criteria:</p>\n<ul>\n<li>Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia</li>\n<li>Adult (18 Years and above)</li>\n<li>Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative).</li>\n<li>Understands and agrees to comply with planned study procedures.</li>\n<li>Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH.\nExclusion Criteria:</li>\n<li>Patients with pneumonia or severe illness requiring admission to ICU.</li>\n<li>Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) &lt; 30) or end stage renal disease requiring dialysis</li>\n<li>Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) &gt; 5 times the upper limit of normal).</li>\n<li>Pregnancy or breast feeding.</li>\n<li>Anticipated transfer to another hospital which is not a study site within 72 hours.</li>\n<li>Allergy to any study medication.</li>\n</ul>\n</div></td>\n\n\n</tr>\n\n\n\n<tr>\n\n\n<th scope=\"row\" class=\"row-header\">Copyright</th>\n\n\n\n<td class=\"content-container\"><div><p>Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).</p>\n</div></td>\n\n\n</tr>\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n\n<tr>\n  <th colspan=\"2\" scope=\"row\" class=\"row-header\">Generated using version 0.5.6 of the sample-content-ig Liquid templates</th>\n</tr>\n\n    </tbody>\n  </table>\n</div>"
  },
  "extension" : [
    {
      "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/artifact-publication-status",
      "valueCodeableConcept" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/cited-artifact-status-type",
            "code" : "active",
            "display" : "Active"
          }
        ]
      }
    },
    {
      "url" : "http://hl7.org/fhir/StructureDefinition/artifact-author",
      "valueContactDetail" : {
        "name" : "Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter"
      }
    },
    {
      "url" : "http://hl7.org/fhir/uv/ebm/StructureDefinition/cite-as",
      "valueMarkdown" : "NCT04401202 Eligibility Criteria [Database Entry: FHIR Group Resource]. Contributors: Computable Publishing®: ClinicalTrials.gov-to-FEvIR Converter [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 189713. Revised 2026-08-05. Available at: https://fevir.net/resources/Group/189713. Computable resource at: https://fevir.net/resources/Group/189713#json."
    }
  ],
  "url" : "https://fevir.net/resources/Group/189713",
  "identifier" : [
    {
      "type" : {
        "coding" : [
          {
            "system" : "http://terminology.hl7.org/CodeSystem/v2-0203",
            "code" : "ACSN",
            "display" : "Accession ID"
          }
        ],
        "text" : "FEvIR Object Identifier"
      },
      "system" : "https://fevir.net/FOI",
      "value" : "189713",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    },
    {
      "type" : {
        "text" : "FEvIR Linking Identifier"
      },
      "system" : "https://fevir.net/FLI",
      "value" : "NCT04401202 Eligibility Criteria",
      "assigner" : {
        "display" : "Computable Publishing LLC"
      }
    }
  ],
  "name" : "NCT04401202_Eligibility_Criteria",
  "title" : "NCT04401202 Eligibility Criteria",
  "status" : "active",
  "publisher" : "Computable Publishing LLC",
  "contact" : [
    {
      "telecom" : [
        {
          "system" : "email",
          "value" : "support@computablepublishing.com"
        }
      ]
    }
  ],
  "description" : "Inclusion Criteria:\n* Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia\n* Adult (18 Years and above)\n* Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative).\n* Understands and agrees to comply with planned study procedures.\n* Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH.\nExclusion Criteria:\n* Patients with pneumonia or severe illness requiring admission to ICU.\n* Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) \\< 30) or end stage renal disease requiring dialysis\n* Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) \\> 5 times the upper limit of normal).\n* Pregnancy or breast feeding.\n* Anticipated transfer to another hospital which is not a study site within 72 hours.\n* Allergy to any study medication.",
  "copyright" : "Copyright the Authors else Computable Publishing LLC. Noncommercial use permitted with CC BY-NC-SA 4.0 (https://creativecommons.org/licenses/by-nc-sa/4.0/). Commercial use permitted as agreed in Terms of Use (https://fevir.net/termsofuse).",
  "membership" : "conceptual",
  "combinationMethod" : "all-of",
  "characteristic" : [
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia"
      },
      "exclude" : false,
      "description" : "Patients with mild COVID19 upper respiratory tract infection and with no evidence of pneumonia"
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Adult (18 Years and above)"
      },
      "exclude" : false,
      "description" : "Adult (18 Years and above)"
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative)."
      },
      "exclude" : false,
      "description" : "Written informed consent prior to initiation of any study procedures by the patient (or legally authorized representative)."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Understands and agrees to comply with planned study procedures."
      },
      "exclude" : false,
      "description" : "Understands and agrees to comply with planned study procedures."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH."
      },
      "exclude" : false,
      "description" : "Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR) available at KAUH."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Patients with pneumonia or severe illness requiring admission to ICU."
      },
      "exclude" : true,
      "description" : "Patients with pneumonia or severe illness requiring admission to ICU."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) \\< 30) or end stage renal disease requiring dialysis"
      },
      "exclude" : true,
      "description" : "Severe chronic kidney disease (i.e. estimated glomerular filtration rate (eGFR) \\< 30) or end stage renal disease requiring dialysis"
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) \\> 5 times the upper limit of normal)."
      },
      "exclude" : true,
      "description" : "Sever chronic liver disease (Alanine transaminase/aspartate transaminase (ALT/AST) \\> 5 times the upper limit of normal)."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Pregnancy or breast feeding."
      },
      "exclude" : true,
      "description" : "Pregnancy or breast feeding."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Anticipated transfer to another hospital which is not a study site within 72 hours."
      },
      "exclude" : true,
      "description" : "Anticipated transfer to another hospital which is not a study site within 72 hours."
    },
    {
      "code" : {
        "text" : "Defined by CodeableConcept"
      },
      "valueCodeableConcept" : {
        "text" : "Allergy to any study medication."
      },
      "exclude" : true,
      "description" : "Allergy to any study medication."
    }
  ]
}