Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04510402
Status:
UNKNOWN
Last Update Posted:
2020-08-12
First Post:
2020-08-10
Brief Title:
Phase III Trial of Povidone-iodine PVP-I Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Phase III Trial Safety and Dosing of Povidone-iodine PVP-I Nasal Swab For Preventing COVID-19 Spread in Healthy Subjects
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Title Phase III 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 III 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
Summary This study will evaluate in a PH III 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
Detailed Description:
Specific Aim 1 Evaluate toxicity and tolerability of PVP-I nasal swabs Specific Aim 2 Investigate the dosing of PVP-I nasal swabs
Hypothesis 1 PVP-I nasal swabs have a low toxicity low side effect profile and high tolerability with daily use
Hypothesis 2 Twice a day dosing for six weeks will prove safe in this subject population
Healthy volunteers living in the Boston area between the ages of 18 and 70 years old will be recruited for participation in this study
Consenting subjects will undergo baseline testing to confirm participants eligibility for this trial As mentioned above the target for enrollment is 50 subjects so it is anticipated that approximately 75 subjects will be recruited consented and screenedtested with about 25 of those subjects being either ineligible after testing or unable to complete the full 12 weeks of the trial Subjects will apply 3Ms PVP-I nasal swabs either once control group or twice treatment group per day depending on the group that participants are randomized into Subjects will apply the nasal swabs daily for six weeks with weekly symptom assessments and testing After subjects cease nasal swab application participants will return after another six weeks ie 12 weeks after participants first nasal swab application for a final round of testing and symptom assessment Subjects will not need to pay for any nasal swabs or visits during this trial - all study-related items and visits will be covered by the sponsor Subjects will also be remunerated with up to 100 dollars in gift certificates if participants complete the study and attend the check-ins 50 dollar certificate for completing baseline visit and 50 dollar certificate for coming in at 12 weeks
Baseline screening will assess the overall health of the subject confirm that participants have no underlying cardiac or thyroid conditions participants are not pregnant serum hCG testing will confirm this nor intend to conceive during the course of this trial and that participants are not experiencing any symptoms of COVID-19 eg coughing fever shortness of breath Further testing will include thyroid stimulating hormone TSH thyroid peroxidase TPO antibody serum human chorionic gonadotropin hCG to test for pregnancy urine iodine and COVID-19 mRNA for the presence of an active virus and antibody as evidence for previous COVID-19 infection Some of these tests will be administered weekly at baseline only at six weeks or at 12 weeks All research-related phlebotomy for this study will take place at BWH clinical research phlebotomy labs such as the Clinical Trials Hub at 60 Fenwood Road or the Clinical Trials Center at 15 Francis Street Again all tests are covered by study funding and subjects will never be charged for them
Once subjects test results are returned and participants are deemed eligible for the study participants will meet with the investigator in a clinical exam room with masks and 6 feet social distance and the investigator will demonstrate how to apply the nasal swabs so that the subject can continue to apply the swabs by themselves for the duration of the study The investigator will assure that the subject has learned how to apply the nasal swab correctly and safely and that the subject understands the importance of daily regimented application Alternatively if the subject would prefer to minimize in-person contact with others participants can obtain the study drug from the investigator or study staff and learn how to apply the swabs through a Zoom meeting Further a video detailing these instructions will be sent to subjects with detailed application instructions
Subjects will also be given a questionnaire to fill out at each weekly check-in which will assess any side effects participants may be experiencing related to this drug questionnaire is attached to this IRB submission on Insight Questions will be focused on symptoms of hyperthyroidism eg palpitations tremulousness weight loss irritability and hypothyroidism eg fatigue weight gain sluggishness hair loss Subjects will also be informed at the time of enrollment that if participants start experiencing any troubling side effects participants should stop applying swabs and alert study staff or an investigator of these side effects as soon as participants can If this happens or if a subjects test results reveal markers that are outside of reference ranges participants will be withdrawn from the study and investigators will explain why participants are being withdrawn Investigators will closely monitor the safety of patients and alert the FDA and the BWH IRB if any adverse events occur However given the proven safety of PVP-I and the weekly testing and assessments the investigators are conducting the investigators do not anticipate that any adverse events will occur
The overall study from initiation and patient recruitment to data analysis and synthesis of a detailed report is anticipated to take six months
Hypothesis 1 PVP-I nasal swabs have a low toxicity low side effect profile and high tolerability with daily use
Hypothesis 2 Twice a day dosing for six weeks will prove safe in this subject population
Healthy volunteers living in the Boston area between the ages of 18 and 70 years old will be recruited for participation in this study
Consenting subjects will undergo baseline testing to confirm participants eligibility for this trial As mentioned above the target for enrollment is 50 subjects so it is anticipated that approximately 75 subjects will be recruited consented and screenedtested with about 25 of those subjects being either ineligible after testing or unable to complete the full 12 weeks of the trial Subjects will apply 3Ms PVP-I nasal swabs either once control group or twice treatment group per day depending on the group that participants are randomized into Subjects will apply the nasal swabs daily for six weeks with weekly symptom assessments and testing After subjects cease nasal swab application participants will return after another six weeks ie 12 weeks after participants first nasal swab application for a final round of testing and symptom assessment Subjects will not need to pay for any nasal swabs or visits during this trial - all study-related items and visits will be covered by the sponsor Subjects will also be remunerated with up to 100 dollars in gift certificates if participants complete the study and attend the check-ins 50 dollar certificate for completing baseline visit and 50 dollar certificate for coming in at 12 weeks
Baseline screening will assess the overall health of the subject confirm that participants have no underlying cardiac or thyroid conditions participants are not pregnant serum hCG testing will confirm this nor intend to conceive during the course of this trial and that participants are not experiencing any symptoms of COVID-19 eg coughing fever shortness of breath Further testing will include thyroid stimulating hormone TSH thyroid peroxidase TPO antibody serum human chorionic gonadotropin hCG to test for pregnancy urine iodine and COVID-19 mRNA for the presence of an active virus and antibody as evidence for previous COVID-19 infection Some of these tests will be administered weekly at baseline only at six weeks or at 12 weeks All research-related phlebotomy for this study will take place at BWH clinical research phlebotomy labs such as the Clinical Trials Hub at 60 Fenwood Road or the Clinical Trials Center at 15 Francis Street Again all tests are covered by study funding and subjects will never be charged for them
Once subjects test results are returned and participants are deemed eligible for the study participants will meet with the investigator in a clinical exam room with masks and 6 feet social distance and the investigator will demonstrate how to apply the nasal swabs so that the subject can continue to apply the swabs by themselves for the duration of the study The investigator will assure that the subject has learned how to apply the nasal swab correctly and safely and that the subject understands the importance of daily regimented application Alternatively if the subject would prefer to minimize in-person contact with others participants can obtain the study drug from the investigator or study staff and learn how to apply the swabs through a Zoom meeting Further a video detailing these instructions will be sent to subjects with detailed application instructions
Subjects will also be given a questionnaire to fill out at each weekly check-in which will assess any side effects participants may be experiencing related to this drug questionnaire is attached to this IRB submission on Insight Questions will be focused on symptoms of hyperthyroidism eg palpitations tremulousness weight loss irritability and hypothyroidism eg fatigue weight gain sluggishness hair loss Subjects will also be informed at the time of enrollment that if participants start experiencing any troubling side effects participants should stop applying swabs and alert study staff or an investigator of these side effects as soon as participants can If this happens or if a subjects test results reveal markers that are outside of reference ranges participants will be withdrawn from the study and investigators will explain why participants are being withdrawn Investigators will closely monitor the safety of patients and alert the FDA and the BWH IRB if any adverse events occur However given the proven safety of PVP-I and the weekly testing and assessments the investigators are conducting the investigators do not anticipate that any adverse events will occur
The overall study from initiation and patient recruitment to data analysis and synthesis of a detailed report is anticipated to take six months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None