SARS-CoV-2 Acute Respiratory DiseasePhase 4NCT05745467
Povidone Iodine Nasal Application to Prevent Intraoperative Spread of SARS-CoV-2
A Phase 4 study testing Povidone Iodine 5% Soln,Top,Kit in people with SARS-CoV-2 Acute Respiratory Disease, run by University of Iowa.
Trial summary
The primary aim is to test whether preoperative asepsis with 5% nasal povidone iodine versus no preoperative asepsis with 5% nasal povidone iodine reduces proximal and distal SARS-CoV-2 transmission in operating rooms among patients who are acutely infected with SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 to 105 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Acute Respiratory Disease
- What is being tested?
- Povidone Iodine 5% Soln,Top,Kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 3 Jul 2024to 1 Apr 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 105 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult patients
- Undergoing surgery (elective, urgent, or emergent)
- Requiring general anesthesia
- Acutely infected (<= 10 days from diagnosis) with SARS-CoV-2
Who cannot join
- Not general anesthesia
- Not acutely infected (<= 10 days from diagnosis) with SARS-CoV-2
- Allergy to povidone iodine
- Unable to provide consent
- Pregnant individuals
About this study
Official title: Exploring the Impact of Nasal Povidone Iodine for Prevention of Intraoperative Spread of SARS-CoV-2 Nucleic Acid Particles and Assessment of Infectivity of Transmitted Particles
The primary aim is to test whether preoperative asepsis with 5% nasal povidone iodine versus no preoperative asepsis with 5% nasal povidone iodine reduces proximal and distal SARS-CoV-2 transmission in operating rooms among patients who are acutely infected with SARS-CoV-2. The secondary aim is to test viral infectivity.
Read the detailed description
Primary Objectives:
The primary aim is to test whether preoperative asepsis versus no preoperative asepsis reduces intraoperative SARS-CoV-2 transmission among patients acutely infected with SARS-CoV-2 (within 10 days of surgery).
Primary Endpoints:
Proximal and distal contamination with SARS-CoV-2 via nucleic acid detection.
Each patient will undergo induction of anesthesia and stabilization for the planned procedure. Approximately 50% of patients will have received 3M 5% povidone iodine 2 times prior to incision (each nares treated 2 times, 4 swabs, a total of 1 vial per patient) with the first time being before anesthesia administration and the second after anesthesia administration or usual care. Then, the investigators will sample locations for which the investigators detected SARS-CoV-2 transmission during the pilot: anesthesia work area reservoirs (anesthesia attending and assistant hands, patient nasopharynx, axilla and groin, and the anesthesia machine vaporizer at case end and at case start, and the patient intravenous stopcock at case end) and the operating room environment (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction cannister, circulating nurse mouse, walls at 6 feet, walls at the base of the floor, and air intake registers). A subset of all samples except patient nasopharynx, axilla, and groin at case beginning will be combined and processed together. Subsets of patient nasopharynx, axilla, and groin samples at case beginning will be combined and processed together. All samples will be stored separately. All samples will be collected before cleaning, transported to the laboratory, and analyzed using real-time PCR for viral detection. Samples will be saved for analysis of viral infectivity and for potential evaluation of each individual sample.
Secondary Objectives:
The secondary aim is to determine transmission of particles with infectivity.
Secondary Endpoints:
Proximal and distal environmental contamination with SARS-CoV-2 via viral culture.
All samples received in the laboratory will be assessed for infectivity in collaboration with Dr. Stanley Perlman, a preeminent expert in coronaviruses. Serial 1:10 dilutions of the 1mL primary collections in phosphate buffered saline (PBS) will be used to inoculate Vero E6 cells, incubating for 45 minutes at 37°C for plaque assay. Medium containing virus will be removed, and the cells allowed to incubate overnight in D10 media. Plaque counts will be determined the following day by combining 1% neutral red with 2× media plus agarose and incubating the cells for approximately 3 hours. All samples will be tested in triplicate with replicate experiments.
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Being tested
- Povidone Iodine 5% Soln,Top,Kit
- Keywords
- General anesthetic, povidone iodine, transmission, infectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Povidone Iodine 5% Soln,Top,KitDrug
Also called MPN: 192401, 3M Skin and Nasal Antiseptic Preoperative Preparation
5% povidone iodine will be swabbed in patients nares of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Povidone Iodine | Experimental | 5% povidone iodine will be swabbed in patients' nares (experimental group), one in each nostril, twice before incision. Receives: Drug: Povidone Iodine 5% Soln,Top,Kit |
| Usual Care | No intervention | Half of the patients will not receive 5% povidone iodine and will proceed with usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of SARS-CoV-2 nucleic acid particles in proximal and distal operating room locations using real time PCR in SARS-CoV-2 acutely infected patients receiving perioperative application of nasal 5% povidone iodine.
The proximal (anesthesia attending and assistant hands, patient nasopharynx, axilla, and groin, anesthesia machine vaporizer, and patient intravenous stopcock) and distal (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction canister, circulating nurse house, walls at 6 feet and at base of the floor, and air intake registers) locations will be evaluated with real time PCR for the presence of SARS-CoV-2 nucleic acid particles. This will be evaluate for patients receiving normal care and for patients receiving nasal 5% povidone iodine preoperatively. All of the samples except for patient nasopharynx, axilla, and groin at case beginning will be pooled together and evaluated. Patient nasopharynx, axilla, and groin at case beginning will be evaluated separately.
Measured: 4 hours
Secondary outcomes (1)
Viral load of the proximal and distal samples collected for the primary outcome will be evaluated with tissue cultures using Vero E6 cells and plaque counting.
Serial 1:10 dilutions of the 1mL primary collections in phosphate buffered saline (PBS) will be used to inoculate Vero E6 cells, incubating for 45 minutes at 37°C for plaque assay. Medium containing virus will be removed, and the cells allowed to incubate overnight in D10 media. Plaque counts will be determined the following day by combining 1% neutral red with 2x media plus agarose and incubating the cells for approximately 3 hours. All samples will be tested in triplicates with replicate experiments. The amount of plaques counted will be converted into PFU/ml as the outcome measure.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start3 Jul 2024 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
Why it stopped: Wouldn't be able to get enough patients. Never started the study. Suspended the IRB form.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for SARS-CoV-2 Acute Respiratory DiseaseStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Sixty-two adult patients with acute SARS-CoV-2 infection undergoing surgery (elective, urgent or emergent) at the University of Iowa will be randomized 1:1 to each of two groups, 3M 5% povidone iodine (treatment) or usual care. Vaccination status will be recorded. Patients randomized to treatment will receive 2 doses of 3M 5% nasal povidone iodine preoperatively given that this dose is commonly used to prevent surgical site infections.7 The first dose will occur prior to induction of anesthesia and the second dose will occur after induction of anesthesia and patient stabilization (in preoperative holding for elective patients or in the operating room for urgent/emergent surgery) but before incision and will involve application to each nares using 2 swabs per nares, 4 swabs per patient.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- 3M
- Responsible party
- Sponsor
- Investigators
- Randy W Loftus, MD, Study director, University of IowaStephanie N Gibbons, BS, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05745467
- Sponsor's protocol ID
- 202212396
- Status last verified
- Nov 2023
- First submitted
- 18 Jan 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the IPD upon review of requests. Requests will be determined appropriate or not by the PI in which the PI will decide whether or not to share the data no early than 1 year following publication of the manuscript.
Publications
Dexter F, Parra MC, Brown JR, Loftus RW. Perioperative COVID-19 Defense: An Evidence-Based Approach for Optimization of Infection Control and Operating Room Management. Anesth Analg. 2020 Jul;131(1):37-42. doi: 10.1213/ANE.0000000000004829.
PubMed 32217947Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.
PubMed 32219407Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.
PubMed 29907449Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.
PubMed 29307750Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.
PubMed 29966756Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.
PubMed 24937345Robinson ADM, Dexter F, Renkor V, Reddy S, Loftus RW. Operating room PathTrac analysis of current intraoperative Staphylococcus aureus transmission dynamics. Am J Infect Control. 2019 Oct;47(10):1240-1247. doi: 10.1016/j.ajic.2019.03.028. Epub 2019 Apr 27.
PubMed 31036398Wu S, Wang Y, Jin X, Tian J, Liu J, Mao Y. Environmental contamination by SARS-CoV-2 in a designated hospital for coronavirus disease 2019. Am J Infect Control. 2020 Aug;48(8):910-914. doi: 10.1016/j.ajic.2020.05.003. Epub 2020 May 12.
PubMed 32407826Wu J, Huang Y, Tu C, Bi C, Chen Z, Luo L, Huang M, Chen M, Tan C, Wang Z, Wang K, Liang Y, Huang J, Zheng X, Liu J. Household Transmission of SARS-CoV-2, Zhuhai, China, 2020. Clin Infect Dis. 2020 Nov 19;71(16):2099-2108. doi: 10.1093/cid/ciaa557.
PubMed 32392331Loftus RW, Dexter F, Parra MC, Brown JR. In Response: 'Perioperative COVID-19 Defense: An Evidence-Based Approach for Optimization of Infection Control and Operating Room Management'. Anesth Analg. 2020 Jul;131(1):e27-e28. doi: 10.1213/ANE.0000000000004854. No abstract available.
PubMed 32250978Chin AWH, Chu JTS, Perera MRA, Hui KPY, Yen HL, Chan MCW, Peiris M, Poon LLM. Stability of SARS-CoV-2 in different environmental conditions. Lancet Microbe. 2020 May;1(1):e10. doi: 10.1016/S2666-5247(20)30003-3. Epub 2020 Apr 2. No abstract available.
PubMed 32835322Wagner JA, Dexter F, Greeley DG, Schreiber K. Operating room air delivery design to protect patient and surgical site results in particles released at surgical table having greater concentration along walls of the room than at the instrument tray. Am J Infect Control. 2021 May;49(5):593-596. doi: 10.1016/j.ajic.2020.10.003. Epub 2020 Oct 9.
PubMed 33039512Loftus RW, Dexter F, Evans LC, Robinson ADM, Odle A, Perlman S. An assessment of the impact of recommended anesthesia work area cleaning procedures on intraoperative SARS-CoV-2 contamination, a case-series analysis. J Clin Anesth. 2021 Oct;73:110350. doi: 10.1016/j.jclinane.2021.110350. Epub 2021 May 25. No abstract available.
PubMed 34098391STONE JD, BURNET FM. The action of halogens on influenza virus with special reference to the action of iodine vapour on virus mists. Aust J Exp Biol Med Sci. 1945;23:205-12. doi: 10.1038/icb.1945.32. No abstract available.
PubMed 21006104
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Nasal Povidone Iodine for Prevention of Intraoperative Spread of SARS-CoV-2 Nucleic Acid Particles and Assessment of Infectivity of Transmitted Particles
- ClinicalTrials.gov ID
- NCT05745467
- Acronym / sponsor ID
- 202212396
- Conditions
- SARS-CoV-2 Acute Respiratory Disease
- Keywords
- General anesthetic, povidone iodine, transmission, infectivity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Wouldn't be able to get enough patients. Never started the study. Suspended the IRB form.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- 3M
- Study start
- 3 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim is to test whether preoperative asepsis with 5% nasal povidone iodine versus no preoperative asepsis with 5% nasal povidone iodine reduces proximal and distal SARS-CoV-2 transmission in operating rooms among patients who are acutely infected with SARS-CoV-2. The secondary aim is to test viral infectivity.
Detailed description
Primary Objectives:
The primary aim is to test whether preoperative asepsis versus no preoperative asepsis reduces intraoperative SARS-CoV-2 transmission among patients acutely infected with SARS-CoV-2 (within 10 days of surgery).
Primary Endpoints:
Proximal and distal contamination with SARS-CoV-2 via nucleic acid detection.
Each patient will undergo induction of anesthesia and stabilization for the planned procedure. Approximately 50% of patients will have received 3M 5% povidone iodine 2 times prior to incision (each nares treated 2 times, 4 swabs, a total of 1 vial per patient) with the first time being before anesthesia administration and the second after anesthesia administration or usual care. Then, the investigators will sample locations for which the investigators detected SARS-CoV-2 transmission during the pilot: anesthesia work area reservoirs (anesthesia attending and assistant hands, patient nasopharynx, axilla and groin, and the anesthesia machine vaporizer at case end and at case start, and the patient intravenous stopcock at case end) and the operating room environment (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction cannister, circulating nurse mouse, walls at 6 feet, walls at the base of the floor, and air intake registers). A subset of all samples except patient nasopharynx, axilla, and groin at case beginning will be combined and processed together. Subsets of patient nasopharynx, axilla, and groin samples at case beginning will be combined and processed together. All samples will be stored separately. All samples will be collected before cleaning, transported to the laboratory, and analyzed using real-time PCR for viral detection. Samples will be saved for analysis of viral infectivity and for potential evaluation of each individual sample.
Secondary Objectives:
The secondary aim is to determine transmission of particles with infectivity.
Secondary Endpoints:
Proximal and distal environmental contamination with SARS-CoV-2 via viral culture.
All samples received in the laboratory will be assessed for infectivity in collaboration with Dr. Stanley Perlman, a preeminent expert in coronaviruses. Serial 1:10 dilutions of the 1mL primary collections in phosphate buffered saline (PBS) will be used to inoculate Vero E6 cells, incubating for 45 minutes at 37°C for plaque assay. Medium containing virus will be removed, and the cells allowed to incubate overnight in D10 media. Plaque counts will be determined the following day by combining 1% neutral red with 2× media plus agarose and incubating the cells for approximately 3 hours. All samples will be tested in triplicate with replicate experiments.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sixty-two adult patients with acute SARS-CoV-2 infection undergoing surgery (elective, urgent or emergent) at the University of Iowa will be randomized 1:1 to each of two groups, 3M 5% povidone iodine (treatment) or usual care. Vaccination status will be recorded. Patients randomized to treatment will receive 2 doses of 3M 5% nasal povidone iodine preoperatively given that this dose is commonly used to prevent surgical site infections.7 The first dose will occur prior to induction of anesthesia and the second dose will occur after induction of anesthesia and patient stabilization (in preoperative holding for elective patients or in the operating room for urgent/emergent surgery) but before incision and will involve application to each nares using 2 swabs per nares, 4 swabs per patient.
| Arm | Type | Receives |
|---|---|---|
| Povidone Iodine | Experimental | Drug: Povidone Iodine 5% Soln,Top,Kit5% povidone iodine will be swabbed in patients' nares (experimental group), one in each nostril, twice before incision. |
| Usual Care | No intervention | –Half of the patients will not receive 5% povidone iodine and will proceed with usual care. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Undergoing surgery (elective, urgent, or emergent)
- Requiring general anesthesia
- Acutely infected (<= 10 days from diagnosis) with SARS-CoV-2
Key exclusion criteria (5 listed)
- Not general anesthesia
- Not acutely infected (<= 10 days from diagnosis) with SARS-CoV-2
- Allergy to povidone iodine
- Unable to provide consent
- Pregnant individuals
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 |
|---|---|---|
| Povidone Iodine 5% Soln,Top,KitAlso: MPN: 192401, 3M Skin and Nasal Antiseptic Preoperative Preparation5% povidone iodine will be swabbed in patients nares of the experimental group. | Drug | Povidone Iodine |
Primary outcome
Detection of SARS-CoV-2 nucleic acid particles in proximal and distal operating room locations using real time PCR in SARS-CoV-2 acutely infected patients receiving perioperative application of nasal 5% povidone iodine.
Time frame: 4 hours
The proximal (anesthesia attending and assistant hands, patient nasopharynx, axilla, and groin, anesthesia machine vaporizer, and patient intravenous stopcock) and distal (anesthesia cart handles, anesthesia provider mouse, top of anesthesia cart, anesthesia suction canister, circulating nurse house, walls at 6 feet and at base of the floor, and air intake registers) locations will be evaluated with real time PCR for the presence of SARS-CoV-2 nucleic acid particles. This will be evaluate for patients receiving normal care and for patients receiving nasal 5% povidone iodine preoperatively. All of the samples except for patient nasopharynx, axilla, and groin at case beginning will be pooled together and evaluated. Patient nasopharynx, axilla, and groin at case beginning will be evaluated separately.
1 secondary outcome
Viral load of the proximal and distal samples collected for the primary outcome will be evaluated with tissue cultures using Vero E6 cells and plaque counting.
Time frame: 4 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Background: PubMed 32217947Dexter F, Parra MC, Brown JR, Loftus RW. Perioperative COVID-19 Defense: An Evidence-Based Approach for Optimization of Infection Control and Operating Room Management. Anesth Analg. 2020 Jul;131(1):37-42. doi: 10.1213/ANE.0000000000004829.
- Background: PubMed 32219407Loftus RW, Dexter F, Goodheart MJ, McDonald M, Keech J, Noiseux N, Pugely A, Sharp W, Sharafuddin M, Lawrence WT, Fisher M, McGonagill P, Shanklin J, Skeete D, Tracy C, Erickson B, Granchi T, Evans L, Schmidt E, Godding J, Brenneke R, Persons D, Herber A, Yeager M, Hadder B, Brown JR. The Effect of Improving Basic Preventive Measures in the Perioperative Arena on Staphylococcus aureus Transmission and Surgical Site Infections: A Randomized Clinical Trial. JAMA Netw Open. 2020 Mar 2;3(3):e201934. doi: 10.1001/jamanetworkopen.2020.1934.
- Background: PubMed 29907449Loftus RW, Dexter F, Robinson ADM. High-risk Staphylococcus aureus transmission in the operating room: A call for widespread improvements in perioperative hand hygiene and patient decolonization practices. Am J Infect Control. 2018 Oct;46(10):1134-1141. doi: 10.1016/j.ajic.2018.04.211. Epub 2018 Jun 12.
- Background: PubMed 29307750Loftus RW, Dexter F, Robinson ADM. Methicillin-resistant Staphylococcus aureus has greater risk of transmission in the operating room than methicillin-sensitive S aureus. Am J Infect Control. 2018 May;46(5):520-525. doi: 10.1016/j.ajic.2017.11.002. Epub 2018 Jan 4.
- Background: PubMed 29966756Loftus RW, Dexter F, Robinson ADM, Horswill AR. Desiccation tolerance is associated with Staphylococcus aureus hypertransmissibility, resistance and infection development in the operating room. J Hosp Infect. 2018 Nov;100(3):299-308. doi: 10.1016/j.jhin.2018.06.020. Epub 2018 Jun 30.
- Background: PubMed 24937345Loftus RW, Koff MD, Brown JR, Patel HM, Jensen JT, Reddy S, Ruoff KL, Heard SO, Yeager MP, Dodds TM. The epidemiology of Staphylococcus aureus transmission in the anesthesia work area. Anesth Analg. 2015 Apr;120(4):807-18. doi: 10.1213/ANE.0b013e3182a8c16a.
- Background: PubMed 31036398Robinson ADM, Dexter F, Renkor V, Reddy S, Loftus RW. Operating room PathTrac analysis of current intraoperative Staphylococcus aureus transmission dynamics. Am J Infect Control. 2019 Oct;47(10):1240-1247. doi: 10.1016/j.ajic.2019.03.028. Epub 2019 Apr 27.
- Background: PubMed 32407826Wu S, Wang Y, Jin X, Tian J, Liu J, Mao Y. Environmental contamination by SARS-CoV-2 in a designated hospital for coronavirus disease 2019. Am J Infect Control. 2020 Aug;48(8):910-914. doi: 10.1016/j.ajic.2020.05.003. Epub 2020 May 12.
- Background: PubMed 32392331Wu J, Huang Y, Tu C, Bi C, Chen Z, Luo L, Huang M, Chen M, Tan C, Wang Z, Wang K, Liang Y, Huang J, Zheng X, Liu J. Household Transmission of SARS-CoV-2, Zhuhai, China, 2020. Clin Infect Dis. 2020 Nov 19;71(16):2099-2108. doi: 10.1093/cid/ciaa557.
- Background: PubMed 32250978Loftus RW, Dexter F, Parra MC, Brown JR. In Response: 'Perioperative COVID-19 Defense: An Evidence-Based Approach for Optimization of Infection Control and Operating Room Management'. Anesth Analg. 2020 Jul;131(1):e27-e28. doi: 10.1213/ANE.0000000000004854. No abstract available.
- Background: PubMed 32835322Chin AWH, Chu JTS, Perera MRA, Hui KPY, Yen HL, Chan MCW, Peiris M, Poon LLM. Stability of SARS-CoV-2 in different environmental conditions. Lancet Microbe. 2020 May;1(1):e10. doi: 10.1016/S2666-5247(20)30003-3. Epub 2020 Apr 2. No abstract available.
- Background: PubMed 33039512Wagner JA, Dexter F, Greeley DG, Schreiber K. Operating room air delivery design to protect patient and surgical site results in particles released at surgical table having greater concentration along walls of the room than at the instrument tray. Am J Infect Control. 2021 May;49(5):593-596. doi: 10.1016/j.ajic.2020.10.003. Epub 2020 Oct 9.
- Individual participant dataSharing planned: Yes. We plan to share the IPD upon review of requests. Requests will be determined appropriate or not by the PI in which the PI will decide whether or not to share the data no early than 1 year following publication of the manuscript.
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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.
Randy W Loftus, MD study director
University of Iowa
Stephanie N Gibbons, BS principal investigator
University of Iowa
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Povidone Iodine 5% Soln,Top,Kit in people with SARS-CoV-2 Acute Respiratory Disease, run by University of Iowa.
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 4 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Detection of SARS-CoV-2 nucleic acid particles in proximal and distal operating room locations using real time PCR in SARS-CoV-2 acutely infected patients receiving perioperative application of nasal 5% povidone iodine. (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05745467, which also lists 14 linked publications.
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 18 Nov 2023.