InfluenzaEMIT-2NCT05666245
DMID 21-0041; Influenza CVD 59000
A study testing Personal Protective Equipment (PPE) - Under High Air Hygiene and Personal Protective Equipment (PPE) - Under Low Air Hygiene in people with Influenza, run by University of Maryland, Baltimore at 2 sites in United States.
Trial summary
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Personal Protective Equipment (PPE) - Under High Air Hygiene and Personal Protective Equipment (PPE) - Under Low Air Hygiene
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Feb 2023to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provides written informed consent, able to comply with the planned study procedures, available for between 2 and 5 days stay in the research quarantine unit for the CHIVITT, and have the ability to attend the scheduled follow-up visits.
- Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted).
- Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent.
- Pregnancy and breastfeeding status to be determined by self-report
- Laboratory-confirmed influenza infection within the past 48 hours at time of entry into the exposure event.
- A rapid antigen test in the setting of known local influenza activity and with symptoms suggestive of influenza at that time is acceptable
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- Within the past 48 hours at time of entry into the exposure event, onset of influenza-like illness, as defined as fever (measured oral temperature of ≥100.2°F or self-reported fever in the absence of a measured temperature) AND cough or sore throat, or onset of less specific symptoms with a positive molecular test for influenza virus infection
- No self-reported or known history of alcohol or drug abuse within the past two years and no illicit drug use within the last 30 days.
- Do not have clinically significant medical, psychiatric, and chronic or intermittent health conditions including those listed in Exclusion Criteria.
- Does not have an ongoing symptomatic condition for which subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan.
- e.g., ongoing and debilitating fatigue without a diagnosis for the symptom.
- Agrees to the collection of specimens for secondary research.
- Enrolled in the Recipient Protocol (University of Maryland, Baltimore Institutional Review Board HP-97730)
- Provides written informed consent, able to comply with the planned study procedures, be available for an up to ~14-day stay for the CHIVITT and have the ability to attend the scheduled follow-up visits.
- Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted).
- No change in smoker status, alcoholism, or illicit drug use status, as compared from their responses collected during screening (EMIT-2 Recipient Protocol). (Prescribed stimulants for the treatment of attention deficit hyperactivity disorder [ADHD] and cannabinoids use do not constitute exclusionary criteria)
- No significant change (for the worse) in general health history or in concomitant medication use, as compared from their responses collected during screening (EMIT-2 Recipient Protocol).
- Agree not to meet with other participants (recipients or donors) outside of the programmed exposure events during the course of their participation in the CHIVITT.
Who cannot join
- Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon admission to the hotel quarantine unit.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s)5
- Significant medical or psychiatric conditions include but are not limited to:
- Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma, cystic fibrosis) requiring daily medications6 currently or any treatment of respiratory disease exacerbations or hospitalizations for acute respiratory illnesses (e.g., asthma exacerbation) in the last 5 years.
- Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short-acting beta agonists, theophylline, ipratropium, biologics.
- Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
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- Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
- Ongoing malignancy or recent diagnosis of malignancy, including leukemia; treated, non-melanoma skin cancers are permissible.
- An autoimmune disease. f. An immunodeficiency of any cause. g. A blood disorder (e.g., sickle cell disease) h. Endocrine disorders (e.g., diabetes) i. Liver, kidney, metabolic disorders j. BMI ≥40 kg/m2 k. Any other condition or behavior that in the opinion of the PI would affect the ability to participate in the transmission study over the next several days.
- Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness7.
- Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.
- Is a habitual smoker8 of tobacco, marijuana, or e-cigarettes per self-report.
- Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion.
- Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to acetaminophen/paracetamol).
- History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis.
- Presence of co-infection with SARS-CoV-2, as detected via a multiplex nucleic acid amplification test (e.g., Biofire).
- Participating in any other interventional clinical research study that has a scheduled intervention 30 days prior to the CHIVITT or 30 after discharge from the research quarantine unit.
- Any condition, to include medical and psychiatric conditions, that in the opinion of the Investigator, might interfere with the safety of the subject or the study objectives.
- For Recipients:
- Female of childbearing potential who has a positive urine pregnancy test within 24 hours of admission to the hotel quarantine unit or is breastfeeding or planning to become pregnant within 2 months after entry into a CHIVITT.
- Presence of infection with influenza, SARS-CoV-2, or other respiratory pathogens detected via a multiplex nucleic acid amplification test (e.g., Biofire) at admission to the hotel quarantine facility.
- Within the past 72 hours, presence of influenza-like illness, as defined as fever of ≥100.2°F AND cough or sore throat, in the absence of an alternative cause.
- Receipt of any blood products within the past 2 months.
- Does not agree to provide permission for secondary research use of extra samples collected and stored specimens.
- Habitual smoker of tobacco, marijuana, or e-cigarettes per self-report. (Habitual smokers are those who smoke or vape more than four cigarettes, other tobacco products, e-cigarettes or marijuana in a week for more than three months or use an inhaled nicotine or marijuana product more than 3 days a week on average. Edible or patch forms of tobacco or marijuana products do not constitute an exclusion.)
- Self-reported or known history of alcohol or drug abuse in the past two years and no illicit drug use within the last 30 days.
- Has an ongoing symptomatic condition1 for which the subject has had or has ongoing medical investigations but has not yet received a diagnosis or treatment plan.
- e.g., ongoing chronic fatigue without a diagnosis for symptom.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s)2
- Significant medical or psychiatric conditions include but are not limited to:
- Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma, cystic fibrosis) requiring daily medications* currently or any treatment of respiratory disease exacerbations or hospitalizations for acute respiratory illnesses (e.g., asthma exacerbation) in the last 5 years.
- Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short-acting beta agonists, theophylline, ipratropium, biologics.
- Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
- Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
- Ongoing malignancy or recent diagnosis of malignancy, including leukemia; treated, non-melanoma skin cancers are permissible.
- An autoimmune disease.
- An immunodeficiency of any cause.
- A blood disorder (e.g., sickle cell disease)
- Endocrine disorders (e.g., diabetes)
- Liver, kidney, metabolic disorders
- BMI ≥40 kg/m2
- Any other condition or behavior that in the opinion of the PI would affect the ability to participate in the screening or future transmission studies.
- Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness3.
- Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.
- Known allergy or intolerance to treatments for influenza and other respiratory infections (including but not limited to oseltamivir, baloxavir, acetaminophen/paracetamol).
- History of a previous severe allergic reaction to medicines of any kind with generalized urticaria, angioedema, or anaphylaxis.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health
Baltimore, Maryland, 21201
University of Maryland, College Park School of Public Health
College Park, Maryland, 20742
About this study
Official title: Evaluating Modes of Influenza Transmission Through the Conduct of Controlled Human Influenza Virus Infection Transmission Trials (CHIVITTs)
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.
- Conditions
- Influenza
- Being tested
- Personal Protective Equipment (PPE) - Under High Air Hygiene, No Intervention - Under High Air Hygiene, Personal Protective Equipment (PPE) - Under Low Air Hygiene, No Intervention - Under Low Air Hygiene
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal Protective Equipment (PPE) - Under High Air HygieneBehavioural
Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces.
High air hygiene is achieved by filtration and/or use of germicidal UV-C.
No Intervention - Under High Air HygieneBehavioural
No intervention
High air hygiene is achieved by filtration and/or use of germicidal UV-C.
Personal Protective Equipment (PPE) - Under Low Air HygieneBehavioural
Intervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces.
Low air hygiene is achieved with minimal ventilation.
No Intervention - Under Low Air HygieneBehavioural
No intervention
Low air hygiene is achieved with minimal ventilation.
| Study group | Role | What they receive |
|---|---|---|
| Donors | Other | Donors are persons naturally infected with influenza. Receives: Behavioral: No Intervention - Under High Air Hygiene; Behavioral: No Intervention - Under Low Air Hygiene |
| Intervention Recipients | Experimental | Intervention recipients are participants who do not have influenza and will use personal protective equipment. Receives: Behavioral: Personal Protective Equipment (PPE) - Under High Air Hygiene; Behavioral: Personal Protective Equipment (PPE) - Under Low Air Hygiene |
| Control Recipients | No intervention | Control recipients are participants who do not have influenza and will not be using personal protective equipment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Viral Confirmation
Proportion of recipients with viral confirmation of influenza infection
Measured: 2 weeks
Symptomatic Confirmation
Proportion of recipients with symptomatic confirmation of influenza infection
Measured: 2 weeks
Serological Confirmation
Proportion of recipients with serological confirmation of influenza infection
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start20 Feb 2023
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, College Park, National Institute of Allergy and Infectious Diseases (NIAID)
- Responsible party
- Principal investigator, Wilbur Chen, MD, MS, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05666245
- Sponsor's protocol ID
- HP-00103865
- Other IDs
- U19AI162130
- Acronym
- EMIT-2
- Status last verified
- Aug 2025
- First submitted
- 16 Dec 2022
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Modes of Influenza Transmission Through the Conduct of Controlled Human Influenza Virus Infection Transmission Trials (CHIVITTs)
- ClinicalTrials.gov ID
- NCT05666245
- Acronym / sponsor ID
- EMIT-2 / HP-00103865
- Conditions
- Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- University of Maryland, College Park, National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 27 Dec 2022 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of EMIT-2 is to use a randomized controlled trial (RCT) design to implement interventions which are known to reduce inhalation (airborne) transmission, so that the contribution of transmission by route of aerosols for influenza may be identified.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Donors | Other | Behavioral: No Intervention - Under High Air Hygiene, Behavioral: No Intervention - Under Low Air HygieneDonors are persons naturally infected with influenza. |
| Intervention Recipients | Experimental | Behavioral: Personal Protective Equipment (PPE) - Under High Air Hygiene, Behavioral: Personal Protective Equipment (PPE) - Under Low Air HygieneIntervention recipients are participants who do not have influenza and will use personal protective equipment. |
| Control Recipients | No intervention | –Control recipients are participants who do not have influenza and will not be using personal protective equipment. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (18 listed)
- Provides written informed consent, able to comply with the planned study procedures, available for between 2 and 5 days stay in the research quarantine unit for the CHIVITT, and have the ability to attend the scheduled follow-up visits.
- Subjects must be able to comprehend the study requirements, as evidenced by a score of ≥70% or better on the comprehension assessment (two attempts permitted).
- Males and non-pregnant, non-breastfeeding females1 aged ≥18 and ≤59 years of age, at time of initial consent.
- Pregnancy and breastfeeding status to be determined by self-report
- Laboratory-confirmed influenza infection within the past 48 hours at time of entry into the exposure event.
Key exclusion criteria (46 listed)
- Female of childbearing potential who is breastfeeding or has positive urine pregnancy test upon admission to the hotel quarantine unit.
- Presence of self-reported or medically documented significant medical or psychiatric condition(s)5
- Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids, leukotriene modifiers, long and short-acting beta agonists, theophylline, ipratropium, biologics.
- Presence of immunosuppression or any medications that may be associated with impaired immune responsiveness7.
- Including, but not limited to, corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or systemic corticosteroids or other similar or toxic drugs during the preceding 12-month period. Low dose topical and intranasal steroid preparations used for a discrete period are permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal Protective Equipment (PPE) - Under High Air HygieneIntervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. High air hygiene is achieved by filtration and/or use of germicidal UV-C. | Behavioural | Intervention Recipients |
| No Intervention - Under High Air HygieneNo intervention High air hygiene is achieved by filtration and/or use of germicidal UV-C. | Behavioural | Donors |
| Personal Protective Equipment (PPE) - Under Low Air HygieneIntervention Recipients (IRs) will be required to wear a lightweight plastic face shield, comply with hand hygiene (i.e., using a hand sanitization product every 15 minutes, plus periodic hand washing with soap and water), and avoid face touching during each planned exposure event. The face shield may only be removed after leaving the exposure room to go to the bathroom, for other short comfort breaks, and at mealtimes. In these instances, hand hygiene will be used after removing or replacing the face shield; and Donors will not be present. Hand washing with soap and water will be required before meals. IR will be separated from Donors by more than 6 feet during meals. The exposure room will be supervised by a trained member of the study staff who will monitor to ensure that Intervention Recipients wear the face shield continuously, are separated from Donors at meals, and do not touch their faces. Low air hygiene is achieved with minimal ventilation. | Behavioural | Intervention Recipients |
| No Intervention - Under Low Air HygieneNo intervention Low air hygiene is achieved with minimal ventilation. | Behavioural | Donors |
Primary outcome
Viral Confirmation
Time frame: 2 weeks
Proportion of recipients with viral confirmation of influenza infection
Symptomatic Confirmation
Time frame: 2 weeks
Proportion of recipients with symptomatic confirmation of influenza infection
Serological Confirmation
Time frame: 2 weeks
Proportion of recipients with serological confirmation of influenza infection
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal Protective Equipment (PPE) - Under High Air Hygiene and Personal Protective Equipment (PPE) - Under Low Air Hygiene in people with Influenza, run by University of Maryland, Baltimore at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 46 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Viral Confirmation (time frame: 2 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.