<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/NCT03794804</url>
  </required_header>
  <id_info>
    <org_study_id>008618</org_study_id>
    <nct_id>NCT03794804</nct_id>
  </id_info>
  <brief_title>Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold</brief_title>
  <official_title>Double-blind, Randomized, Parallel-group, Placebo-controlled Study to Evaluate Efficacy of CMS008618 for Common Cold</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Enzymatica AB</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Analyze &amp; Realize</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Enzymatica AB</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common&#xD;
      cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a&#xD;
      placebo device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 28, 2019</start_date>
  <completion_date type="Actual">June 26, 2019</completion_date>
  <primary_completion_date type="Actual">June 26, 2019</primary_completion_date>
  <phase>N/A</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>WURSS-21 QoL sub score</measure>
    <time_frame>Days 1-8 (day 1 is the first day of symptoms)</time_frame>
    <description>The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>1. Composite daily severity of all symptoms within the Jackson score</measure>
    <time_frame>Days 1-8 (day 1 is the first day of symptoms)</time_frame>
    <description>The first major secondary endpoint: AUC days 1-8 composite daily severity of all symptoms within the Jackson score (mean of morning and evening) (day 1 is the first day of symptom recording)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms</measure>
    <time_frame>Days 1-4 (day 1 is the first day of symptoms)</time_frame>
    <description>The second major secondary endpoint: Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/ anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose, expressed as number of days with concomitant treatment during the first 4 days for each subject (based on diary data).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item</measure>
    <time_frame>Days 1-8 (day 1 is the first day of symptoms)</time_frame>
    <description>AUC days 1-8 for each single WURSS-21 QoL subscore item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)</measure>
    <time_frame>Days 1-8 (day 1 is the first day of symptoms)</time_frame>
    <description>AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)</measure>
    <time_frame>Days 1-8 (day 1 is the first day of symptoms)</time_frame>
    <description>AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose</measure>
    <time_frame>Days 1-4</time_frame>
    <description>Frequency of subjects with use of concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of duration of first intense phase</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring &lt;5 in total Jackson score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of symptom intensity</measure>
    <time_frame>Days 1-4</time_frame>
    <description>Assessment of symptom intensity, expressed as mean total Jackson score days 1-4</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of symptom sore throat per Sore Throat Scale</measure>
    <time_frame>Days 1-8</time_frame>
    <description>Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of subjects with confirmed common cold at Visit 2</measure>
    <time_frame>1-3 days after symptom start</time_frame>
    <description>Percentage of subjects with confirmed common cold at Visit 2 (from all subjects with V2), which should take place within 1-3 days after symptom start</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Global evaluation of efficacy by subjects and investigators at study end</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: &quot;very good&quot;, &quot;good&quot;, &quot;moderate&quot; and &quot;poor&quot;</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety endpoint: Physical examination</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Physical examination: standard clinical examination of the gastrointestinal tract, cardiovascular system, eyes, respiratory tract, lymph nodes, musculoskeletal system, neurological functions, urogenital tract, thyroid gland and skin.</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety endpoint: Vital signs</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Vital signs: blood pressure (mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety endpoint: Vital signs</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Vital signs: pulse rate (bpm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety endpoint: Global evaluation of tolerability by subjects and investigators</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Global evaluation of tolerability by subjects and investigators at study end, 4-point categorical scale: &quot;very good&quot;, &quot;good&quot;, &quot;moderate&quot; and &quot;poor&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety endpoint: Assessment of adverse events</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Assessment of adverse events throughout the study</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety endpoint: Assessment of device deficiencies</measure>
    <time_frame>From enrolment through study completion, maximum 16 weeks</time_frame>
    <description>Assessment of device deficiencies at V2 and V3</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">701</enrollment>
  <condition>Common Cold</condition>
  <arm_group>
    <arm_group_label>ColdZyme</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.&#xD;
The IP use should start when following conditions have been fulfilled:&#xD;
Answering &quot;Yes&quot; to either of the questions in the subject daily diary: &quot;Do you think/feel you have a cold?&quot; or &quot;Do you think/feel you are coming down with a cold (might be having the first signs of cold)?&quot; AND&#xD;
A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache&#xD;
The IP should be used until 2 days after the subject is symptom free (=answering &quot;No&quot; to the question &quot;Do you think that you are still sick with this respiratory infection?&quot; for 2 days in a row), but not longer than 10 days in total.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.&#xD;
The IP use should start when following conditions have been fulfilled:&#xD;
Answering &quot;Yes&quot; to either of the questions in the subject daily diary: &quot;Do you think/feel you have a cold?&quot; or &quot;Do you think/feel you are coming down with a cold (might be having the first signs of cold)?&quot; AND&#xD;
A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache&#xD;
The IP should be used until 2 days after the subject is symptom free (=answering &quot;No&quot; to the question &quot;Do you think that you are still sick with this respiratory infection?&quot; for 2 days in a row), but not longer than 10 days in total.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ColdZyme</intervention_name>
    <description>ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (&lt;1 %), calcium chloride, trometamol and menthol.&#xD;
ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.</description>
    <arm_group_label>ColdZyme</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ColdZyme Placebo</intervention_name>
    <description>The placebo mouth spray solution has the following composition: ethanol (&lt;1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Men and women&#xD;
&#xD;
          2. Age 18 to 70 years old&#xD;
&#xD;
          3. Increased risk for common cold (at least 3 self-reported occurences of common cold&#xD;
             within the last 12 months prior to V1) but generally in good health&#xD;
&#xD;
          4. Readiness to comply with trial procedures, including in particular:&#xD;
&#xD;
               -  Use of IP as recommended&#xD;
&#xD;
               -  Filling in diary&#xD;
&#xD;
               -  Keeping habitual life-style, including diet and physical activity level&#xD;
&#xD;
               -  No use of products that may influence the study outcome (e.g. immune&#xD;
                  suppressants/immune stimulants including natural health products,&#xD;
                  analgesics/anti-rheumatics, anti-phlogistics, anti-tussives/expectorants, mouth&#xD;
                  or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs,&#xD;
                  nasal drops/spray) during the study (except for the defined &quot;rescue&quot; treatment)&#xD;
&#xD;
          5. Women of child-bearing potential:&#xD;
&#xD;
               -  Have to agree to use appropriate contraception methods&#xD;
&#xD;
               -  Negative pregnancy testing (beta human chorionic gonadotropin test in urine) at&#xD;
                  V1&#xD;
&#xD;
        Participation is based upon written informed consent by the participant following written&#xD;
        and oral information by the investigator regarding nature,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known allergy or hypersensitivity to the components of the investigational product&#xD;
&#xD;
          2. History and/or presence of clinically significant condition/ disorder (self-reported),&#xD;
             which per investigator's judgement could interfere with the results of the study or&#xD;
             the safety of the subject, e.g.:&#xD;
&#xD;
               -  Nasal disorder (e.g. polyposis, relevant septal deviation, ulcer etc.) and/or&#xD;
                  reconstructive surgery&#xD;
&#xD;
               -  Asthma, chronic obstructive lung disease or any other acute/chronic airways&#xD;
                  disease/disorder (e.g. chronic cough of any origin)&#xD;
&#xD;
               -  Acute psychiatric disorders&#xD;
&#xD;
               -  Any other acute/chronic serious organ or systemic diseases&#xD;
&#xD;
          3. Influenza vaccination within the last 3 months prior to V1 and during the study&#xD;
&#xD;
          4. Regular use of products that may influence the study outcome (e.g. immune&#xD;
             suppressants/immune stimulants including natural health products,&#xD;
             analgesics/anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or&#xD;
             throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal&#xD;
             drops/spray) within the last 4 weeks prior to V1&#xD;
&#xD;
          5. Pregnancy or nursing&#xD;
&#xD;
          6. History of (in the past 12 months prior to V1) or current abuse of drugs, alcohol or&#xD;
             medication&#xD;
&#xD;
          7. Participation in the present study of a person living in the same household as the&#xD;
             subject&#xD;
&#xD;
          8. Inability to comply with study requirements according to investigator's judgement&#xD;
&#xD;
          9. Participation in another clinical study in the 30 days prior to V1 and during the&#xD;
             study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ralf Uebelhack, Prof. Dr. med.</last_name>
    <role>Principal Investigator</role>
    <affiliation>analyze &amp; realize GmbH</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>analyze &amp; realize GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>emovis GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin-Mitte GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinische Forschung Berlin</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polikum Institut GmbH</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Frau Barbara Grube</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Wünsche</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BioTeSys GmbH</name>
      <address>
        <city>Esslingen</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Praxis Dr. med. Gudrun Ruhland</name>
      <address>
        <city>Koßdorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIBAmed Studienzentrum GmbH und Co. KG</name>
      <address>
        <city>Leipzig</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</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>Common Cold</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to fredrik.lindberg@enzymatica.com. To gain access, data requestors will need to sign a data access agreement.</ipd_access_criteria>
  </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/NCT03794804
org study id: 008618
nct id: NCT03794804
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of ColdZyme® Mouth Spray on quality of life during common
      cold. Half of the participants will receive ColdZyme® Mouth Spray, half will receive a
      placebo device.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: WURSS-21 QoL sub score
time frame: Days 1-8 (day 1 is the first day of symptoms)
description: The primary endpoint is the AUC of Wisconsin Upper Respiratory Symptom Survey (WURSS-21) Quality of Life composite subscore during first 8 days of symptoms, to be assessed in comparison between verum and placebo.
measure: 1. Composite daily severity of all symptoms within the Jackson score
time frame: Days 1-8 (day 1 is the first day of symptoms)
description: The first major secondary endpoint: AUC days 1-8 composite daily severity of all symptoms within the Jackson score (mean of morning and evening) (day 1 is the first day of symptom recording)
measure: 2. Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms
time frame: Days 1-4 (day 1 is the first day of symptoms)
description: The second major secondary endpoint: Exposure to any concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/ anti-rheumatics, anti-phlogistics, antitussives/ expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose, expressed as number of days with concomitant treatment during the first 4 days for each subject (based on diary data).
measure: Other secondary endpoints: AUC days 1-8 for each single WURSS-21 QoL subscore item
time frame: Days 1-8 (day 1 is the first day of symptoms)
description: AUC days 1-8 for each single WURSS-21 QoL subscore item
measure: AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening)
time frame: Days 1-8 (day 1 is the first day of symptoms)
description: AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
measure: AUC days 1-8 composite daily severity of each individual symptom of the Jackson score (mean of morning and evening)
time frame: Days 1-8 (day 1 is the first day of symptoms)
description: AUC days 1-8 composite daily severity of all local symptoms within the Jackson score (mean of morning and evening) item
measure: Frequency of subjects with use of concomitant treatment that may affect common cold symptoms or any medication/treatment known to affect common cold symptoms - at any dose
time frame: Days 1-4
description: Frequency of subjects with use of concomitant treatment (including natural health products) that may affect common cold symptoms - immune suppressants/immune stimulants, analgesics/anti-rheumatics, anti-phlogistics, antitussives/expectorants, mouth or throat therapeutics, decongestants, antibiotics, anti-histaminergic drugs, nasal drops/spray or any medication/treatment known to affect common cold symptoms - at any dose
measure: Assessment of duration of first intense phase
time frame: From enrolment through study completion, maximum 16 weeks
description: Assessment of duration of first intense phase, expressed as number of days from start of treatment until scoring <5 in total Jackson score
measure: Assessment of symptom intensity
time frame: Days 1-4
description: Assessment of symptom intensity, expressed as mean total Jackson score days 1-4
measure: Assessment of symptom sore throat per Sore Throat Scale
time frame: Days 1-8
description: Assessment of symptom sore throat per Sore Throat Scale, expressed as AUC days 1-8
measure: Percentage of subjects with confirmed common cold at Visit 2
time frame: 1-3 days after symptom start
description: Percentage of subjects with confirmed common cold at Visit 2 (from all subjects with V2), which should take place within 1-3 days after symptom start
measure: Global evaluation of efficacy by subjects and investigators at study end
time frame: From enrolment through study completion, maximum 16 weeks
description: Global evaluation of efficacy by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"
measure: Safety endpoint: Physical examination
time frame: From enrolment through study completion, maximum 16 weeks
description: Physical examination: standard clinical examination of the gastrointestinal tract, cardiovascular system, eyes, respiratory tract, lymph nodes, musculoskeletal system, neurological functions, urogenital tract, thyroid gland and skin.
measure: Safety endpoint: Vital signs
time frame: From enrolment through study completion, maximum 16 weeks
description: Vital signs: blood pressure (mmHg)
measure: Safety endpoint: Vital signs
time frame: From enrolment through study completion, maximum 16 weeks
description: Vital signs: pulse rate (bpm)
measure: Safety endpoint: Global evaluation of tolerability by subjects and investigators
time frame: From enrolment through study completion, maximum 16 weeks
description: Global evaluation of tolerability by subjects and investigators at study end, 4-point categorical scale: "very good", "good", "moderate" and "poor"
measure: Safety endpoint: Assessment of adverse events
time frame: From enrolment through study completion, maximum 16 weeks
description: Assessment of adverse events throughout the study
measure: Safety endpoint: Assessment of device deficiencies
time frame: From enrolment through study completion, maximum 16 weeks
description: Assessment of device deficiencies at V2 and V3
arm group label: ColdZyme
arm group type: Active Comparator
description: ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.
The IP use should start when following conditions have been fulfilled:
Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND
A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache
The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.
arm group label: Placebo
arm group type: Placebo Comparator
description: Water based mouth spray manufactured to be similar to ColdZyme® Mouth Spray. The IP should be applied every second hour up to 6 times, with each time 2 sprays (1 dose) per occasion.
The IP use should start when following conditions have been fulfilled:
Answering "Yes" to either of the questions in the subject daily diary: "Do you think/feel you have a cold?" or "Do you think/feel you are coming down with a cold (might be having the first signs of cold)?" AND
A Jackson score of at least 1 in the subject's cold diary (mild = present, but not disturbing or irritating) for any symptom except headache
The IP should be used until 2 days after the subject is symptom free (=answering "No" to the question "Do you think that you are still sick with this respiratory infection?" for 2 days in a row), but not longer than 10 days in total.
intervention type: Device
intervention name: ColdZyme
description: ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
arm group label: ColdZyme
intervention type: Device
intervention name: ColdZyme Placebo
description: The placebo mouth spray solution has the following composition: ethanol (<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ralf Uebelhack, Prof. Dr. med.
role: Principal Investigator
affiliation: analyze & realize GmbH
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country: Germany
responsible party type: Sponsor
mesh term: Common Cold
sharing ipd: Yes
ipd description: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Beginning 3 months and ending 5 years following article publication.
ipd access criteria: Individual participant data that underlie the results reported, after deidentification (text, tables, figures, and appendices) will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to fredrik.lindberg@enzymatica.com. To gain access, data requestors will need to sign a data access agreement.