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All Studies   Meta Analysis    Recent:   

Efficacy of povidone-iodine nasal rinse and mouth wash in COVID-19 management: a prospective, randomized pilot clinical trial (povidone-iodine in COVID-19 management)

Alsaleh et al., BMC Infectious Diseases, doi:10.1186/s12879-024-09137-y (date from preprint), NCT04449965
Dec 2023  
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Recovery, day 4 16% Improvement Relative Risk Recovery, day 18 -40% Recovery, day 12 13% Recovery, day 10 61% Recovery, day 8 67% Recovery, day 6 -3% Recovery, day 4 (b) 16% Recovery, day 2 -68% Improvement in viral load 73% Time to viral- 22% Povidone-Iodine  Alsaleh et al.  EARLY TREATMENT  RCT Is early treatment with povidone-iodine beneficial for COVID-19? RCT 13 patients in Saudi Arabia (August 2021 - July 2022) No significant difference in outcomes seen c19early.org Alsaleh et al., BMC Infectious Diseases, Dec 2023 Favorspovidone-iodine Favorscontrol 0 0.5 1 1.5 2+
PVP-I for COVID-19
13th treatment shown to reduce risk in February 2021
 
*, now with p = 0.000000004 from 21 studies.
Lower risk for mortality, cases, and viral clearance.
No treatment is 100% effective. Protocols combine treatments. * >10% efficacy, ≥3 studies.
5,000+ studies for 104 treatments. c19early.org
Tiny RCT with 5 PVP-I patients, 6 saline patients, and 8 control patients, showing improved viral clearance with 0.23% povidone-iodine (PVP-I) nasal rinses and mouthwashes. No significant differences were found for viral load by PCR cycle threshold values or patient-reported symptom scales.
Authors claim the trial is placebo controlled, however they state that the control group "did not receive any intervention".
WURSS-11 was higher in the PVP-I group vs. control at baseline (29 vs. 24).
Authors report that patients developed symptoms within the last three days, however the mean baseline Ct for the PVP-I group was 23, indicating high viral load and suggesting later treatment.
Figure 1 shows patients lost to followup in both the PVP-I and NS groups. For PVP-I, Figure 2 indicates a patient censored at day 4 and only 4 patients with further data, but Table 2 shows a mean viral clearance of 9.8 days from 5 patients.
risk of no recovery, 16.4% lower, RR 0.84, p = 0.76, treatment mean 4.6 (±4.0) n=4, control mean 5.5 (±5.0) n=8, mid-recovery, day 4.
risk of no recovery, 40.0% higher, RR 1.40, p = 0.73, treatment mean 2.8 (±4.0) n=4, control mean 2.0 (±3.5) n=8, day 18.
risk of no recovery, 13.0% lower, RR 0.87, p = 0.89, treatment mean 2.0 (±1.0) n=4, control mean 2.3 (±4.0) n=8, day 12.
risk of no recovery, 61.4% lower, RR 0.39, p = 0.28, treatment mean 2.7 (±3.0) n=4, control mean 7.0 (±7.1) n=8, day 10.
risk of no recovery, 66.7% lower, RR 0.33, p = 0.36, treatment mean 1.0 (±1.0) n=4, control mean 3.0 (±4.0) n=8, inverted to make RR<1 favor treatment, day 8.
risk of no recovery, 3.1% higher, RR 1.03, p = 0.96, treatment mean 3.3 (±3.0) n=4, control mean 3.2 (±3.0) n=8, day 6.
risk of no recovery, 16.4% lower, RR 0.84, p = 0.76, treatment mean 4.6 (±4.0) n=4, control mean 5.5 (±5.0) n=8, day 4.
risk of no recovery, 68.0% higher, RR 1.68, p = 0.07, treatment mean 16.3 (±6.0) n=4, control mean 9.7 (±5.0) n=8, day 2.
relative improvement in viral load, 72.7% better, RR 0.27, p = 0.72, treatment mean 2.2 (±4.88) n=5, control mean 0.6 (±8.7) n=8, day 4.
time to viral-, 22.2% lower, relative time 0.78, p = 0.02, treatment mean 9.8 (±1.6) n=4, control mean 12.6 (±1.68) n=8.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Alsaleh et al., 6 Dec 2023, Randomized Controlled Trial, Saudi Arabia, peer-reviewed, median age 38.0, 9 authors, study period August 2021 - July 2022, trial NCT04449965 (history). Contact: alhussienah@gmail.com.
This PaperPovidone-Iod..All
Efficacy of povidone-iodine nasal rinse and mouth wash in COVID-19 management: a prospective, randomized pilot clinical trial (povidone-iodine in COVID-19 management)
Saad Alsaleh, Ahmed Alhussien, Abduljabbar Alyamani, Fahad Alhussain, Ali Alhijji, Khalifa Binkhamis, Anas Khan, Amin Javer, Fatimah S Alshahrani
BMC Infectious Diseases, doi:10.1186/s12879-024-09137-y
Objectives/Hypothesis To 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 design This was an open-label, prospective, randomized, placebo-controlled clinical trial.
Supplementary Information The online version contains supplementary material available at https://doi. org/10.1186/s12879-024-09137-y. Supplementary Material 1 Author contributions Saad Alsaleh (SA) and Amin Javer (AJ) conceptualized the study. Ahmed Alhussien (AH) curated the data and performed formal analysis. SA secured funding for the project. AH, Abduljabbar Alyamani (AY), Fahad Alhussain (FA), Ali Alhijji (AJ), and Khalifa Binkhamis (KB) contributed to the investigation. SA, AJ, KB, Anas Khan (AK), and Fatimah Al-Shahrani (FA) contributed to the methodology. AH, AJ, and KB were involved in project administration. SA, KB, AK, and FA provided resources. AH developed the software. SA supervised the project. KB validated the findings. SA visualized the data. AH, AY, and FA drafted the original manuscript. SA, KB, and AJ reviewed and edited the manuscript. All authors reviewed the final manuscript. Declarations Ethics approval and consent to participate The study was approved by the King Saud University Institutional Review Board and the Saudi Food and Drug Authority Clinical Trial Unit. All patients who met the inclusion criteria signed a written informed consent form that mentioned possible risks and benefits associated with the intervention. Consent for publication Not applicable. Competing interests The authors declare no competing interests. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and..
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Nasopharyngeal swabs were ' 'taken 4, 8, 12, and 18 days after the first swab to measure the detectability of the virus ' 'and the Ct.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Results</jats:title>\n' ' <jats:p>A 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 (<jats:italic>p</jats:italic>\u2009' '=\u20090.046). The Ct mean values were 23\u2009±\u20093.4, 23.5\u2009±\u20096.3, and ' '26.3\u2009±\u20095.9 at the time of recruitment and 25.2\u2009±\u20093.5, 15\u2009±\u2009' '11.7, and 26.9\u2009±\u20096.4 after 4 days for the PVP-I, NS, and control groups, ' 'respectively.</jats:p>\n' ' </jats:sec><jats:sec>\n' ' <jats:title>Conclusions</jats:title>\n' ' <jats:p>When 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. 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' 'Efficacy of povidone-iodine nasal and oral antiseptic preparations ' 'against severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2). ' 'Ear Nose Throat J. 2021;100(2suppl):192S–6.', 'journal-title': 'Ear Nose Throat J'}, { 'issue': '11', 'key': '9137_CR16', 'doi-asserted-by': 'publisher', 'first-page': '1054', 'DOI': '10.1001/jamaoto.2020.3053', 'volume': '146', 'author': 'S Frank', 'year': '2020', 'unstructured': 'Frank S, Brown SM, Capriotti JA, Westover JB, Pelletier JS, Tessema B. ' 'In vitro efficacy of a povidone-iodine nasal antiseptic for rapid ' 'inactivation of SARS-CoV-2. JAMA Otolaryngology–Head Neck Surg. ' '2020;146(11):1054–8.', 'journal-title': 'JAMA Otolaryngology–Head Neck Surg'}, { 'key': '9137_CR17', 'doi-asserted-by': 'crossref', 'unstructured': 'Liang B, Yuan X, Wei G, Wang W, Zhang M, Peng H et al. In-vivo toxicity ' 'studies and in-vitro inactivation of SARS-CoV-2 by povidone-iodine ' 'in-situ gel forming formulations. BioRxiv. 2020.', 'DOI': '10.1101/2020.05.18.103184'}, { 'issue': '9', 'key': '9137_CR18', 'doi-asserted-by': 'publisher', 'first-page': '586', 'DOI': '10.1177/0145561320932318', 'volume': '99', 'author': 'S Frank', 'year': '2020', 'unstructured': 'Frank S, Capriotti J, Brown SM, Tessema B. Povidone-iodine use in ' 'sinonasal and oral cavities: a review of safety in the COVID-19 era. Ear ' 'Nose Throat J. 2020;99(9):586–93.', 'journal-title': 'Ear Nose Throat J'}, { 'issue': '2', 'key': '9137_CR19', 'doi-asserted-by': 'publisher', 'first-page': '305', 'DOI': '10.1007/s15010-020-01563-9', 'volume': '49', 'author': 'CJ Seneviratne', 'year': '2021', 'unstructured': 'Seneviratne CJ, Balan P, Ko KKK, Udawatte NS, Lai D, Ng DHL, et al. ' 'Efficacy of commercial mouth-rinses on SARS-CoV-2 viral load in saliva: ' 'randomized control trial in Singapore. Infection. 2021;49(2):305–11.', 'journal-title': 'Infection'}, { 'key': '9137_CR20', 'doi-asserted-by': 'crossref', 'unstructured': 'Natto ZS, Bakhrebah MA, Afeef M, Al-Harbi S, Nassar MS, Alhetheel AF et ' 'al. The short-term effect of different chlorhexidine forms versus ' 'povidone iodine mouth rinse in minimizing the oral SARS-CoV-2 viral ' 'load: an open label randomized controlled clinical trial study. ' 'Medicine. 2022;101(30).', 'DOI': '10.1097/MD.0000000000028925'}, { 'issue': '6', 'key': '9137_CR21', 'doi-asserted-by': 'publisher', 'first-page': '103549', 'DOI': '10.1016/j.amjoto.2022.103549', 'volume': '43', 'author': 'PJ Fantozzi', 'year': '2022', 'unstructured': 'Fantozzi PJ, Pampena E, Pierangeli A, Oliveto G, Sorrentino L, di Vanna ' 'D, et al. Efficacy of antiseptic mouthrinses against SARS-CoV-2: a ' 'prospective randomized placebo-controlled pilot study. Am J Otolaryngol. ' '2022;43(6):103549.', 'journal-title': 'Am J Otolaryngol'}, { 'issue': '3', 'key': '9137_CR22', 'doi-asserted-by': 'publisher', 'first-page': '101584', 'DOI': '10.1016/j.jebdp.2021.101584', 'volume': '21', 'author': 'R Elzein', 'year': '2021', 'unstructured': 'Elzein R, Abdel-Sater F, Fakhreddine S, Abi Hanna P, Feghali R, Hamad H, ' 'et al. In vivo evaluation of the virucidal efficacy of chlorhexidine and ' 'povidone-iodine mouthwashes against salivary SARS-CoV-2. A ' 'randomized-controlled clinical trial. J Evid Based Dent Pract. ' '2021;21(3):101584.', 'journal-title': 'J Evid Based Dent Pract'}, { 'issue': '11', 'key': '9137_CR23', 'doi-asserted-by': 'publisher', 'first-page': '903', 'DOI': '10.1016/j.adaj.2021.05.021', 'volume': '152', 'author': 'P Chaudhary', 'year': '2021', 'unstructured': 'Chaudhary P, Melkonyan A, Meethil A, Saraswat S, Hall DL, Cottle J, et ' 'al. Estimating salivary carriage of severe acute respiratory syndrome ' 'coronavirus 2 in nonsymptomatic people and efficacy of mouthrinse in ' 'reducing viral load: a randomized controlled trial. J Am Dent ' 'Association. 2021;152(11):903–8.', 'journal-title': 'J Am Dent Association'}, { 'issue': '1', 'key': '9137_CR24', 'doi-asserted-by': 'publisher', 'first-page': '1', 'DOI': '10.1186/s13063-020-04963-2', 'volume': '22', 'author': 'MJ Hasan', 'year': '2021', 'unstructured': 'Hasan MJ, Rumi SK, Banu SS, Uddin AKM, Islam MS, Arefin MK. Virucidal ' 'effect of povidone iodine on COVID-19 in the nasopharynx: a structured ' 'summary of a study protocol for an open-label randomized clinical trial. ' 'Trials. 2021;22(1):1–2.', 'journal-title': 'Trials'}, { 'issue': '11', 'key': '9137_CR25', 'doi-asserted-by': 'publisher', 'first-page': '2089', 'DOI': '10.1002/lary.29935', 'volume': '132', 'author': 'D Zarabanda', 'year': '2022', 'unstructured': 'Zarabanda D, Vukkadala N, Phillips KM, Qian ZJ, Mfuh KO, Hatter MJ, et ' 'al. The Effect of Povidone-Iodine nasal spray on nasopharyngeal ' 'SARS‐CoV‐2 viral load: a Randomized Control Trial. Laryngoscope. ' '2022;132(11):2089–95. https://doi.org/10.1002/lary.29935', 'journal-title': 'Laryngoscope'}, { 'issue': '3', 'key': '9137_CR26', 'doi-asserted-by': 'publisher', 'first-page': '573', 'DOI': '10.1007/s40121-020-00324-3', 'volume': '9', 'author': 'SN Rao', 'year': '2020', 'unstructured': 'Rao SN, Manissero D, Steele VR, Pareja J. A systematic review of the ' 'clinical utility of cycle threshold values in the context of COVID-19. ' 'Infect Dis Ther. 2020;9(3):573–86.', 'journal-title': 'Infect Dis Ther'}, { 'issue': '9', 'key': '9137_CR27', 'doi-asserted-by': 'publisher', 'first-page': '1882', 'DOI': '10.3390/v13091882', 'volume': '13', 'author': 'E Domingo', 'year': '2021', 'unstructured': 'Domingo E, García-Crespo C, Lobo-Vega R, Perales C. Mutation rates, ' 'mutation frequencies, and proofreading-repair activities in RNA virus ' 'genetics. Viruses. 2021;13(9):1882.', 'journal-title': 'Viruses'}, { 'issue': '2', 'key': '9137_CR28', 'first-page': '249', 'volume': '7', 'author': 'M Eggers', 'year': '2018', 'unstructured': 'Eggers M, Koburger 一 Janssen T, Eickmann M, et al. H Diro bactericidal ' 'and virucidal efficacy of povidone 一 iodine ' 'gargle/mouthwashagainstrespiratoryand oraltract pathogens J. Infect ' 'DisTher. 2018;7(2):249–59.', 'journal-title': 'Infect DisTher'}, { 'issue': '3', 'key': '9137_CR29', 'doi-asserted-by': 'publisher', 'first-page': '632', 'DOI': '10.1210/jcem-66-3-632', 'volume': '66', 'author': 'ADERAW PAUL', 'year': '1988', 'unstructured': 'Paul Aderaw, Reinhardt TL, Safran W, Pino M, McARTHUR Sam. Effect of ' 'mouth rinsing with two polyvinylpyrrolidone-iodine mixtures on iodine ' 'absorption and thyroid function. J Clin Endocrinol Metab. ' '1988;66(3):632–5.', 'journal-title': 'J Clin Endocrinol Metab'}, { 'issue': '4', 'key': '9137_CR30', 'doi-asserted-by': 'publisher', 'first-page': '400', 'DOI': '10.1001/jamaoto.2020.5490', 'volume': '147', 'author': 'J Guenezan', 'year': '2021', 'unstructured': 'Guenezan J, Garcia M, Strasters D, Jousselin C, Lévêque N, Frasca D, et ' 'al. Povidone iodine mouthwash, gargle, and nasal spray to reduce ' 'nasopharyngeal viral load in patients with COVID-19: a randomized ' 'clinical trial. JAMA Otolaryngology–Head Neck Surg. 2021;147(4):400–1.', 'journal-title': 'JAMA Otolaryngology–Head Neck Surg'}, { 'issue': '2', 'key': '9137_CR31', 'doi-asserted-by': 'publisher', 'first-page': '173', 'DOI': '10.1016/j.ijom.2010.09.012', 'volume': '40', 'author': 'G Arakeri', 'year': '2011', 'unstructured': 'Arakeri G, Brennan PA. Povidone-iodine: an anti-oedematous agent? Int J ' 'Oral Maxillofac Surg. 2011;40(2):173–6.', 'journal-title': 'Int J Oral Maxillofac Surg'}, { 'issue': '6', 'key': '9137_CR32', 'doi-asserted-by': 'publisher', 'first-page': '1148', 'DOI': '10.1002/lary.29818', 'volume': '132', 'author': 'P Wu', 'year': '2022', 'unstructured': 'Wu P, Cheng P, Chang C, Lo W, Cheng P. Efficacy of povidone-iodine nasal ' 'irrigation solution after sinonasal surgery: a randomized controlled ' 'study. Laryngoscope. 2022;132(6):1148–52.', 'journal-title': 'Laryngoscope'}, { 'issue': '5', 'key': '9137_CR33', 'doi-asserted-by': 'publisher', 'first-page': '102604', 'DOI': '10.1016/j.amjoto.2020.102604', 'volume': '41', 'author': 'VS Lee', 'year': '2020', 'unstructured': 'Lee VS, Pottinger PS, Davis GE. Tolerability and effectiveness of ' 'povidone-iodine or mupirocin versus saline sinus irrigations for chronic ' 'rhinosinusitis. Am J Otolaryngol. 2020;41(5):102604.', 'journal-title': 'Am J Otolaryngol'}, { 'issue': '9', 'key': '9137_CR34', 'doi-asserted-by': 'publisher', 'first-page': '989', 'DOI': '10.3390/vaccines9090989', 'volume': '9', 'author': 'YJ Fan', 'year': '2021', 'unstructured': 'Fan YJ, Chan KH, Hung IFN. Safety and efficacy of COVID-19 vaccines: a ' 'systematic review and meta-analysis of different vaccines at phase 3. ' 'Vaccines (Basel). 2021;9(9):989.', 'journal-title': 'Vaccines (Basel)'}, { 'issue': '6', 'key': '9137_CR35', 'doi-asserted-by': 'publisher', 'first-page': '635', 'DOI': '10.1016/S1473-3099(20)30237-1', 'volume': '20', 'author': 'GM Joynt', 'year': '2020', 'unstructured': 'Joynt GM, Wu WKK, Understanding. COVID-19: what does viral RNA load ' 'really mean? Lancet Infect Dis. 2020;20(6):635–6.', 'journal-title': 'Lancet Infect Dis'}, { 'key': '9137_CR36', 'doi-asserted-by': 'publisher', 'unstructured': 'Levy AG, Thorpe A, Scherer LD, Scherer AM, Drews FA, Butler JM et al. ' 'Misrepresentation and Nonadherence Regarding COVID-19 Public Health ' 'Measures. JAMA Netw Open [Internet]. 2022;5(10):e2235837–e2235837. ' 'https://doi.org/10.1001/jamanetworkopen.2022.35837.', 'DOI': '10.1001/jamanetworkopen.2022.35837'}], 'container-title': 'BMC Infectious Diseases', 'original-title': [], 'language': 'en', 'link': [ { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-024-09137-y.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/article/10.1186/s12879-024-09137-y/fulltext.html', 'content-type': 'text/html', 'content-version': 'vor', 'intended-application': 'text-mining'}, { 'URL': 'https://link.springer.com/content/pdf/10.1186/s12879-024-09137-y.pdf', 'content-type': 'application/pdf', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2024, 3, 1]], 'date-time': '2024-03-01T10:02:52Z', 'timestamp': 1709287372000}, 'score': 1, 'resource': { 'primary': { 'URL': 'https://bmcinfectdis.biomedcentral.com/articles/10.1186/s12879-024-09137-y'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2024, 3, 1]]}, 'references-count': 36, 'journal-issue': {'issue': '1', 'published-online': {'date-parts': [[2024, 12]]}}, 'alternative-id': ['9137'], 'URL': 'http://dx.doi.org/10.1186/s12879-024-09137-y', 'relation': {}, 'ISSN': ['1471-2334'], 'subject': ['Infectious Diseases'], 'container-title-short': 'BMC Infect Dis', 'published': {'date-parts': [[2024, 3, 1]]}, 'assertion': [ { 'value': '6 October 2023', 'order': 1, 'name': 'received', 'label': 'Received', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '14 February 2024', 'order': 2, 'name': 'accepted', 'label': 'Accepted', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, { 'value': '1 March 2024', 'order': 3, 'name': 'first_online', 'label': 'First Online', 'group': {'name': 'ArticleHistory', 'label': 'Article History'}}, {'order': 1, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Declarations'}}, { 'value': 'The study was approved by the King Saud University Institutional Review Board ' 'and the Saudi Food and Drug Authority Clinical Trial Unit. All patients who met ' 'the inclusion criteria signed a written informed consent form that mentioned ' 'possible risks and benefits associated with the intervention.', 'order': 2, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Ethics approval and consent to participate'}}, { 'value': 'Not applicable.', 'order': 3, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Consent for publication'}}, { 'value': 'The authors declare no competing interests.', 'order': 4, 'name': 'Ethics', 'group': {'name': 'EthicsHeading', 'label': 'Competing interests'}}], 'article-number': '271'}
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Please send us corrections, updates, or comments. c19early involves the extraction of 100,000+ datapoints from thousands of papers. Community updates help ensure high accuracy. Treatments and other interventions are complementary. All practical, effective, and safe means should be used based on risk/benefit analysis. No treatment or intervention is 100% available and effective for all current and future variants. We do not provide medical advice. Before taking any medication, consult a qualified physician who can provide personalized advice and details of risks and benefits based on your medical history and situation. FLCCC and WCH provide treatment protocols.
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