Objectives:
 

Arm 1 – Healthcare Workers: To utilize povidone iodine nasal spray and gargle as chemical prophylaxis for front line health care workers with efficacy of treatment assessed via pre-intervention COVID19 testing and repeat COVID testing at the end of 3 weeks OR at the time of development of symptoms consistent with COVID19 (fever, cough, anosmia, nasal congestion, conjunctivitis, gastrointestinal symptoms, cardiopulmonary symptoms).

Arm 2 – Hospitalized Patients: To utilize povidone iodine nasal spray and gargle as chemical prophylaxis for preoperative patients and patients who will or have been hospitalized for over 1 week with efficacy of treatment assessed via pre-intervention COVID19 testing and repeat COVID testing at the end of 2 weeks OR at the time of development of symptoms consistent with COVID19 (fever, cough, anosmia, nasal congestion, conjunctivitis, gastrointestinal symptoms, cardiopulmonary symptoms).

Arm 3 – Members of the community: To utilize povidone iodine nasal spray and gargle as chemical prophylaxis for those in the community to prevent contracting COVID 19. Efficacy of treatment will be assessed via pre-intervention COVID19 testing and repeat COVID testing at the end of 3 weeks OR at the time of development of symptoms consistent with COVID19 (fever, cough, anosmia, nasal congestion, conjunctivitis, gastrointestinal symptoms, cardiopulmonary symptoms).

 

Study Design:

Arm 1 - Healthcare Workers:

Front line health care workers (FLHCW) who will be directly interacting with SARS-CoV-2 positive patients will be considered eligible for the study and will be given study materials via email and embedded video.  All interested participants will undergo informed consent per ORI guidelines.  All front-line HCWs are eligible unless they have PREVIOUSLY had a positive test for the novel coronavirus.  HCWs who are pregnant, nursing, have thyroid cancer/disorder, or a shellfish allergy can still participate but will be automatically put into the control group (standard PPE alone without povidone-iodine).  Participants will be given a COVID19 swab test as well as a questionnaire (Q1) assessing study eligibility.  If they test negative, they are eligible for inclusion.  All participants will be offered the intervention.

Standard testing for COVID19 prior to beginning of front-line work to assess for COVID19 status:

FLHCW with negative COVID19 testing prior to enrollment and no symptoms concerning for COVID19 (fever, cough, anosmia, shortness of breath, conjunctivitis) can participate in trial. Those with a positive test will be referred to IPAC for further guidance but will be excluded from the study.

Intervention: The participants will be asked to complete a pre-participation survey via REDCap.  They will then be given premade gargles and nasal sprays .  Povidone-Iodine nasal spray and gargle (10% diluted 1:30) will be used prior to the start of shift, during "lunchbreak", and at the end of shift.  First, the nasal spray will be sprayed in the nose (2 sprays each naris).  For adequate coverage, the participant should be able to taste the iodine or see it in the back of the throat.  This should be left in place for 30 seconds.  Then, the participant will gargle the solution for 30 seconds and not have anything to eat or drink by mouth for 30 minutes. There will be daily questionnaires via REDCap.

Control: For participants who either 1) choose NOT to use the iodine preparation or 2) are allergic, are pregnant, or have thyroid disorders and thus ineligible to receive the nasal preparation, appropriate PPE without povidone-iodine will be utilized. 

After initial use, the participants will be asked to fill out a second questionnaire (Q2) assessing study tolerability. 

After 3 weeks of use OR at the first sign of potential infection, participants will be re-swabbed for COVID19.

Arm 2 - Hospitalized Patients

Given the high rate of asymptomatic carriers, a second arm will also be planned for patients who have a 7+ day hospitalization or who are set to undergo a significant surgical procedure.  These patients will be offered participation in the study as well and will be given the same questionnaire (Q1) and undergo preoperative testing if they consent.  Patients who test positive for COVID19 will be automatically excluded and referred to IPAC.  Patients undergoing surgery for presumed thyroid cancer or who have an allergy to shellfish or contrast dye will automatically be placed into the control group (no iodine preparation).  For patients in the study group, PVIP gargle and nasal sprays will be applied preoperatively or shortly after admission and enrollment in the study for the non-operative group.  The patients will then be retested in 2 weeks or as directed by the presentation of symptoms concerning for infection with SARS-CoV-2.

Arm 3 – Members of the Community

Given the high rate of asymptomatic carriers, a third arm will also be planned for community members interested in participating.  They must have never tested positive for COVID19.

Those who wish to participate in the study will be given the pre screening questionnaire and undergo preoperative testing if they consent.  Participants who test positive for COVID19 will be automatically excluded and referred to their local Department of Public Health.  Those with thyroid dysfunction, an allergy to shellfish or contrast dye, or who are pregnant or breast-feeding will automatically be placed into the control group (no iodine preparation).  For patients in the study group, PVI gargle and nasal sprays will be mailed directly to them. The participants will then be retested in 3 weeks or as directed by the presentation of symptoms concerning for infection with SARS-CoV-2. Daily questionnaires via REDCap will be given to follow up on use and either filled out by the patient if able or by study personnel if assistance is requested.

Control: For participants who either 1) choose NOT to use the iodine preparation OR 2) are allergic, are pregnant, or have thyroid disorders and thus ineligible to receive the nasal preparation, standard precautions without povidone-iodine will be utilized. This will not be randomized and participants can self select to participate in this group but not use the povidone-iodine preparation.

Those in this group will still undergo the pre screening questionnaire, pre study COVID 19 test, daily symptom checks, and post study questionnaire and COVID 19 test.