DMID 21-0041; Influenza CVD 59000

NCT05666245 | Completed Results

• 2 other identifiers: HP-00103865U19AI162130
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Viral Confirmation

  Proportion of recipients with viral confirmation of influenza infection

  2 weeks

• Symptomatic Confirmation

  Proportion of recipients with symptomatic confirmation of influenza infection

  2 weeks

• Serological Confirmation

  Proportion of recipients with serological confirmation of influenza infection

  2 weeks

Study Arms (3)

Donors

OTHER

Donors are persons naturally infected with influenza.

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.

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.

Interventions

Personal Protective Equipment (PPE) - Under High Air Hygiene BEHAVIORAL

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.

Intervention Recipients

No Intervention - Under High Air Hygiene BEHAVIORAL

No intervention High air hygiene is achieved by filtration and/or use of germicidal UV-C.

Donors

Personal Protective Equipment (PPE) - Under Low Air Hygiene BEHAVIORAL

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.

Intervention Recipients

No Intervention - Under Low Air Hygiene BEHAVIORAL

No intervention Low air hygiene is achieved with minimal ventilation.

Donors

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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:
• a. 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.
• b. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.
• c. Neurological or neurodevelopmental conditions (e.g., epilepsy, stroke, seizures, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).
• d. Ongoing malignancy or recent diagnosis of malignancy, including leukemia; treated, non-melanoma skin cancers are permissible.
• e. 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of Maryland, College Park: collaborator
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

University of Maryland, Baltimore, University of Maryland School of Medicine, Center for Vaccine Development and Global Health

Baltimore, Maryland, 21201, United States

Location

University of Maryland, College Park School of Public Health

College Park, Maryland, 20742, United States

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Personal Protective Equipment

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Protective Devices; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture

Limitations and Caveats

The SARS-CoV-2 pandemic significantly interrupted seasonal influenza virus circulation during the years of the study, such that the hotel quarantine transmission study could only be conducted over 2 sequential influenza seasons (2022-23 and 2023-24). The 2022-23 season failed to identify a Donor due to the very early onset of local seasonal influenza that year.

Results Point of Contact

• Title: Wilbur Chen, MD, MS
• Organization: Center for Vaccine Development and Global Health (CVD)

wilbur.chen@som.umaryland.edu

410-706-5328

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: December 16, 2022
• First Posted: December 27, 2022
• Study Start: February 20, 2023
• Primary Completion: April 17, 2024
• Study Completion: April 17, 2024
• Last Updated: August 26, 2025
• Results First Posted: August 26, 2025

Record last verified: 2025-08

Locations

US (2)