Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial.
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ABSTRACT:
SUBMITTER: Guenezan J
PROVIDER: S-EPMC7863011 | biostudies-literature | 2021 Apr
REPOSITORIES: biostudies-literature
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Povidone Iodine Mouthwash, Gargle, and Nasal Spray to Reduce Nasopharyngeal Viral Load in Patients With COVID-19: A Randomized Clinical Trial.
Guenezan Jeremy J Garcia Magali M Strasters Deidre D Jousselin Clément C Lévêque Nicolas N Frasca Denis D Mimoz Olivier O
JAMA otolaryngology-- head & neck surgery 20210401 4
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Project description:Objectives/hypothesisTo determine the effect of povidone-iodine (PVP-I) nasal sprays on nasopharyngeal (NP) viral load as assessed by cycle threshold (Ct) on quantitative polymerase chain reaction (qPCR) of SARS-CoV-2 in outpatients.Study designThree arm, triple blinded, randomized, placebo-controlled clinical trial.MethodsParticipants were randomized within 5 days of testing positive for COVID-19 to receive nasal sprays containing placebo (0.9% saline), 0.5% PVP-I, or 2.0% PVP-I. NP swabs for qPCR analysis were taken at baseline, 1-hour post-PVP-I spray (two sprays/nostril), and 3 days post-PVP-I spray (20 sprays/nostril). Symptom and adverse event questionnaires were completed at baseline, day 3, and day 5. University of Pennsylvania Smell Identification Tests (UPSIT) were completed at baseline and day 30.ResultsMean Ct values increased over time in all groups, indicating declining viral loads, with no statistically significant difference noted in the rate of change between placebo and PVP-I groups. The 2.0% PVP-I group showed statistically significant improvement in all symptom categories; however, it also reported a high rate of nasal burning. Olfaction via UPSIT showed improvement by at least one category in all groups. There were no hospitalizations or mortalities within 30 days of study enrollment.ConclusionsSaline and low concentration PVP-I nasal sprays are well tolerated. Similar reductions in SARS-CoV-2 NP viral load were seen over time in all groups. All treatment groups showed improvement in olfaction over 30 days. These data suggest that dilute versions of PVP-I nasal spray are safe for topical use in the nasal cavity, but that PVP-I does not demonstrate virucidal activity in COVID-19 positive outpatients.Level of evidence2 Laryngoscope, 132:2089-2095, 2022.
| S-EPMC8662040 | biostudies-literature
Project description:With the changing epidemiology of COVID-19 and its impact on our daily lives, there is still an unmet need of COVID-19 therapies treating early infections to prevent progression. The current study was a randomized, parallel, double-blind, placebo-controlled trial. Ninety SARS-CoV-2 positive patients were randomized into 3 groups receiving placebo, 0.02% or 0.1% azelastine nasal spray for 11 days, during which viral loads were assessed by quantitative PCR. Investigators assessed patients' status throughout the trial including safety follow-ups (days 16 and 60). Symptoms were documented in patient diaries. Initial viral loads were log10 6.85 ± 1.31 (mean ± SD) copies/mL (ORF 1a/b gene). After treatment, virus load was reduced in all groups (p < 0.0001) but was greater in the 0.1% group compared to placebo (p = 0.007). In a subset of patients (initial Ct < 25) viral load was strongly reduced on day 4 in the 0.1% group compared to placebo (p = 0.005). Negative PCR results appeared earlier and more frequently in the azelastine treated groups: being 18.52% and 21.43% in the 0.1% and 0.02% groups, respectively, compared to 0% for placebo on day 8. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. The shown effects of azelastine nasal spray may thus be suggestive of azelastine's potential as an antiviral treatment.Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). EudraCT number: 2020-005544-34.
| S-EPMC10132439 | biostudies-literature
Project description:SARS- CoV-2 or novel coronavirus enters in human body through nose and mouth, stays there for a while. Then binds with ACE2 receptor, enters inside cell, multiply there and manifests. Again, Polyvinyl Pyrrolidone or Povidone Iodine (PVP-I) is a strong microbicidal agent having 99.99% virucidal efficacy in its only 0.23% concentration, irrespective of all known viruses, even in SARS- CoV-2 (in vitro). An oro-nasal spray is designed to apply the PVP-I in nose and oral cavity to gain a protective layer or coating over nasal and oral mucosa, so that SARS-CoV-2 can't bind with the ACE-2 receptor and prevent their entry inside. So, it will be effective for prevention of COVID-19. Moreover, as PVP-I has the ability for destruction of SARS-CoV-2, transmission of SARS- CoV-2 from patient will be reduced also. Thus PVP-I oro-nasal spray can act as an effective shield for COVID-19 protection for healthcare workers, for all.
| S-EPMC8026810 | biostudies-literature
Project description:Objectives/hypothesisTo assess the efficacy of 0.23% povidone-iodine (PVP-I) nasal rinses and mouth washes on detectability of the coronavirus disease 2019 (COVID-19) virus and cycle threshold (Ct) values in nasopharyngeal swabs.Study designThis was an open-label, prospective, randomized, placebo-controlled clinical trial.SettingThe study was conducted in King Saud University Medical City, Riyadh, Saudi Arabia, from August 2021 to July 2022.MethodsParticipants diagnosed with SARS-CoV-2 were randomly assigned to one of three groups, with participants receiving either 0.23% PVP-I, 0.9% normal saline (NS) nasal rinses and mouth washes, or no intervention (control group). Nasopharyngeal swabs were taken 4, 8, 12, and 18 days after the first swab to measure the detectability of the virus and the Ct.ResultsA total of 19 participants were involved in this study. The mean viral survival was 9.8, 12, and 12.6 days for the PVP-I, NS, and control groups, respectively, with a statistically significant difference (p = 0.046). The Ct mean values were 23 ± 3.4, 23.5 ± 6.3, and 26.3 ± 5.9 at the time of recruitment and 25.2 ± 3.5, 15 ± 11.7, and 26.9 ± 6.4 after 4 days for the PVP-I, NS, and control groups, respectively.ConclusionsWhen used continuously at a concentration of 0.23%, PVP-I showed promising results in terms of decreasing the pandemic burden by reducing the period of infectiousness and viral load. However, the use of PVP-I did not result in significantly different changes in the quality-of-life parameters in recently vaccinated and mild COVID-19 patients.
| S-EPMC10905910 | biostudies-literature
Project description:IntroductionPreoperative nasal decolonization of surgical patients with nasal povidone-iodine (PI) has potential to eliminate pathogenic organisms responsible for surgical site infections. However, data on implementation of PI for quality improvement in clinical practice is limited. The purpose of this study was to evaluate the implementation feasibility, fidelity and acceptability of intranasal PI solution application by surgical nurses using the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) conceptual framework.Materials and methodsUsing the i-PARIHS framework to frame questions and guide interview content areas, we conducted 15 semi-structured interviews of pre- and post-operative care nurses in two facilities. We analyzed the data using deductive content analysis to evaluate nurses' experience and perceptions on preoperative intranasal PI solution decolonization implementation. Open coding was used to analyze the data to ensure all relevant information was captured.ResultsEach facility adopted a different quality improvement implementation strategy. The mode of facilitation, training, and educational materials provided to the nurses varied by facility. Barriers identified included lack of effective communication, insufficient information and lack of systematic implementation protocol. Action taken to mitigate some of the barriers included a collaboration between the study team and nurses to develop a systematic written protocol. The training assisted nurses to systematically follow the implementation protocol smoothly to ensure PI administration compliance, and to meet the goal of the facilities. Nurses' observations and feedback showed that PI did not cause any adverse effects on patients.ConclusionsWe found that PI implementation was feasible and acceptable by nurses and could be extended to other facilities. However further studies are required to ensure standardization of PI application.
| S-EPMC7676708 | biostudies-literature
Project description:Treatment of Staphylococcus aureus colonization before surgery reduces risk of surgical site infection (SSI). The regimen of nasal mupirocin ointment and topical chlorhexidine gluconate is effective, but cost and patient compliance may be a barrier. Nasal povidone-iodine solution may provide an alternative to mupirocin.We conducted an investigator-initiated, open-label, randomized trial comparing SSI after arthroplasty or spine fusion in patients receiving topical chlorhexidine wipes in combination with either twice daily application of nasal mupirocin ointment during the 5 days before surgery or 2 applications of povidone-iodine solution into each nostril within 2 hours of surgical incision. The primary study end point was deep SSI within the 3 months after surgery.In the modified intent-to-treat analysis, a deep SSI developed after 14 of 855 surgical procedures in the mupirocin group and 6 of 842 surgical procedures in the povidone-iodine group (P = .1); S. aureus deep SSI developed after 5 surgical procedures in the mupirocin group and 1 surgical procedure in the povidone-iodine group (P = .2). In the per protocol analysis, S. aureus deep SSI developed in 5 of 763 surgical procedures in the mupirocin group and 0 of 776 surgical procedures in the povidone-iodine group (P = .03).Nasal povidone-iodine may be considered as an alternative to mupirocin in a multifaceted approach to reduce SSI.ClinicalTrials.gov identifier: NCT01313182.
| S-EPMC4668802 | biostudies-literature
Project description:IntroductionMolluscum contagiosum is a viral infection of the skin that is spread from direct contact, either via person to person by touching affected lesions or innocuously via fomites. The condition is often socially stigmatizing, motivating patients to seek treatment. There are many anecdotal remedies, but none have been overwhelmingly effective in controlled clinical trials.Case reportA 16-year-old girl presented with approximately 75 lesions on her inner thighs as a result of friction from an athletic uniform. She tried over-the-counter antibiotic ointment and topical steroids for several weeks without improvement, and was concerned at the rate of spread of the lesions, along with the social implications.ConclusionThe topical povidone-iodine/dimethylsulfoxide system is very effective in eradicating molluscum contagiosum. This novel combination warrants further investigation in randomized, controlled trials to further elucidate its clinical utility.
| S-EPMC4799036 | biostudies-literature
Project description:The aim of this study was to assess the profile of nasal microbiome and evaluate the effect of a specific nasal decolonization solution on the microbiome. We conducted a randomized, placebo-controlled, and parallel-group clinical study of 50 volunteers aged 18 years and older. The subjects were randomly assigned to receive a nasal antiseptic solution, containing povidone-iodine as the main ingredient, (n = 25) or a control solution (n = 25). Nasal swabs were obtained before application (baseline) and at 3 timepoints after application (5 min, 2 h, 24 h). Nasal swabs were subjected to next generation sequencing analysis and cultured in agar plates. At baseline, there were substantial associations between anaerobic species, Corynebacterium spp., Staphylococcus spp., and Dolosigranulum spp. Then, a high bioburden reduction was observed after the application of povidone-iodine (log10 3.68 ± 0.69 at 5 min; log10 3.57 ± 0.94 at 2 h; log10 1.17 ± 1.40 at 24 h), compared to the control. The top species affected by the treatment were Cutibacterium acnes, Staphylococcus, and Corynebacterium species. None of the subjects experienced any adverse effects, nor increases in mucociliary clearance time. Antiseptic solutions applied to the anterior nares can transiently and markedly reduce the bioburden of the nose. The registration number for this clinical trial is NCT05617729.
| S-EPMC11271270 | biostudies-literature
Project description:PurposeTo evaluate the clinical safety and efficacy of povidone-iodine (PVP-I) 0.6%/dexamethasone (DEX) 0.1% ophthalmic suspension vs vehicle in patients with clinically suspected acute viral conjunctivitis.Patients and methodsThis was a randomized, double-masked, parallel-group, vehicle-controlled study. Adults with a clinical diagnosis of suspected acute viral conjunctivitis were randomized 1:1 to PVP-I/DEX ophthalmic suspension or vehicle bilaterally four times daily for 5 days (Days 1-5). Evaluation was on Days 1, 3 (+1-day window), and 6 (+1). Patients with signs of acute viral conjunctivitis at the Day 6 visit received open-label PVP-I/DEX for five additional days and were evaluated on Day 11-14. The primary efficacy endpoint was clinical resolution of acute viral conjunctivitis in the study eye at the Day 6 visit.ResultsOverall, 132 patients were randomized and received treatment (PVP-I/DEX, n=66; vehicle, n=66); 38 patients continued into the open-label portion of the study. Not enough patients with confirmed adenoviral conjunctivitis (n=32/132) were enrolled to assess the primary endpoint, although there were some efficacy trends in the PVP-I/DEX group for global clinical score (sum of watery conjunctival discharge and bulbar conjunctival redness). There were no serious treatment-emergent adverse events (TEAEs) and no patients discontinued due to a TEAE. In the masked phase, 56.1% of patients receiving PVP-I/DEX experienced at least one TEAE vs 43.9% in the vehicle group; 78.9% of patients in the open-label phase experienced at least one TEAE. Most TEAEs were mild in severity.ConclusionPVP-I/DEX ophthalmic suspension administered for ≤14 days had a favorable safety profile and was generally well tolerated.
| S-EPMC6433103 | biostudies-literature
Project description:BackgroundWe examined whether existing licensed pharmacotherapies could reduce the spread of coronavirus disease 2019 (COVID-19).MethodsAn open-label parallel randomized controlled trial was performed among healthy migrant workers quarantined in a large multi-storey dormitory in Singapore. Forty clusters (each defined as individual floors of the dormitory) were randomly assigned to receive a 42-day prophylaxis regimen of either oral hydroxychloroquine (400 mg once, followed by 200 mg/day), oral ivermectin (12 mg once), povidone-iodine throat spray (3 times/day, 270 μg/day), oral zinc (80 mg/day)/vitamin C (500 mg/day) combination, or oral vitamin C, 500 mg/day. The primary outcome was laboratory evidence of SARS-CoV-2 infection as shown by either: (1) a positive serologic test for SARS-CoV-2 antibody on day 42, or (2) a positive PCR test for SARS-CoV-2 at any time between baseline and day 42.ResultsA total of 3037 asymptomatic participants (mean age, 33.0 years; all men) who were seronegative to SARS-CoV-2 at baseline were included in the primary analysis. Follow-up was nearly complete (99.6%). Compared with vitamin C, significant absolute risk reductions (%, 98.75% confidence interval) were observed for oral hydroxychloroquine (21%, 2-42%) and povidone-iodine throat spray (24%, 7-39%). No statistically significant differences were observed with oral zinc/vitamin C combination (23%, -5 to +41%) and ivermectin (5%, -10 to +22%). Interruptions due to side effects were highest among participants who received zinc/vitamin C combination (6.9%), followed by vitamin C (4.7%), povidone-iodine (2.0%), and hydroxychloroquine (0.7%).ConclusionsChemoprophylaxis with either oral hydroxychloroquine or povidone-iodine throat spray was superior to oral vitamin C in reducing SARS-CoV-2 infection in young and healthy men.
| S-EPMC8056783 | biostudies-literature