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Phase I/II Trial of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT04510402
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
3M
Information provided by (Responsible Party):
Raymond Manohar Anchan, M.D.,Ph.D., Brigham and Women's Hospital

Brief Summary:

Title: Phase I/II Trial (Safety and Dosing) of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects:

Summary: This study will evaluate in a PH I/II trial in healthy volunteers the safety and tolerability of PVP-I nasal swabs daily application. The intent is to follow with a PH III randomized controlled clinical trial to assess the capacity for PVP-I nasal swabs to mitigate the transmission of respiratory viruses specifically COVID 19.


Condition or disease Intervention/treatment Phase
Covid19 Povidone Iodine Adverse Reaction Drug: Povidine iodine nasal swabs Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Fifty healthy volunteers to use single application or double application of PVP-I nasal swabs and assess for safety and tolerability
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase I/II Trial (Safety and Dosing) of Povidone-iodine (PVP-I) Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects
Estimated Study Start Date : August 2020
Estimated Primary Completion Date : February 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Safety Analysis
Evaluate safety of PVP-I nasal swabs single daily application
Drug: Povidine iodine nasal swabs
Daily versus twice daily nasal application

Experimental: Tolerability analysis
Investigate the dosing of PVP-I nasal swabs daily single dosing versus double dosing
Drug: Povidine iodine nasal swabs
Daily versus twice daily nasal application




Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by self reporting, metabolic and endocrine metrics [ Time Frame: follow up until 12 weeks ]
    Safety and tolerability assessment of PVP-I nasal swabs with 5% PVP-I with 0.5% available iodine will be ascertained using weekly measurements of iodine metabolism, thyroid function testing and self reporting of symptoms.


Secondary Outcome Measures :
  1. Number of participants with dose dependent side effects determined by self reporting diaries, thyroid and metabolic testing [ Time Frame: follow up until 12 weeks ]
    Investigate the dosing of PVP-I nasal swabs twice a day for six weeks with follow up to 12 weeks. The investigators will assess for iodine dose dependent side effects, changes in thyroid functions or iodine clearance.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy volunteers from the Boston community
  2. 18-70 years of age
  3. In good health, without thyroid or cardiac disease, without symptoms of COVID-19*
  4. Normal baseline TSH

Exclusion Criteria:

  1. History of thyroid or cardiac disease
  2. Current BWH employee
  3. Allergy or hypersensitivity to iodine
  4. Positive COVID-19 mRNA or antibody test
  5. Participation in any other investigational study or drug trial in which receipt of an investigational study drug occurred within 30 days prior to enrollment in this study
  6. Women who are pregnant or attempting to conceive
  7. Men who are attempting to conceive with their partner

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510402


Contacts
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Contact: Raymond M Anchan, MD, PhD 6177324285 ranchan@bwh.harvard.edu
Contact: Mark D Hornstein, MD 6177324648 mhornstein@bwh.harvard.edu

Sponsors and Collaborators
Brigham and Women's Hospital
3M
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Responsible Party: Raymond Manohar Anchan, M.D.,Ph.D., Assistant Professor HMS, Associate Gynecologist, BWH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT04510402    
Other Study ID Numbers: 2020p002323
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Anonymized, de-identified aggregate data that cannot be traced or linked to the participant.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Povidone-Iodine
Anti-Infective Agents, Local
Anti-Infective Agents