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Combined Nasal, Oropharyngeal Povidone Iodine Plus Glycyrrhizic Acid Sprays, Accelerate Clinical and Laboratory Recovery and Reduces Household Transmission of SARS-CoV-2: A Randomized Placebo-Controlled Clinical Trial

Elsersy et al., Frontiers in Medicine, doi:10.3389/fmed.2022.863917, PACTR202101875903773
Apr 2022  
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Hospitalization 91% Improvement Relative Risk Recovery time 15% Recovery time, smell 49% Recovery time, taste 48% Viral clearance, day 7 68% Viral clearance, day 10 90% Viral clearance, day 4 29% Transmission 92% Transmission (b) 94% Povidone-Iodine  Elsersy et al.  EARLY TREATMENT  DB RCT Is early treatment with povidone-iodine + glycyrrhizic acid beneficial for COVID-19? Double-blind RCT 621 patients in Egypt (March - July 2021) Faster recovery (p=0.008) and improved viral clearance (p<0.0001) c19early.org Elsersy et al., Frontiers in Medicine, Apr 2022 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.
5,100+ studies for 112 treatments. c19early.org
RCT with 200 patients and 421 contacts, with 100 patients and their contacts treated with nasal and oropharyngeal sprays containing povidone-iodine and glycyrrhizic acid, showing significantly faster viral clearance and recovery, and significantly lower transmission.
SOC included vitamin C and zinc. The spray active ingredients included a compound of glycyrrhizic acid in the form of ammonium glycyrrhizate 2.5 mg/ml plus PVI 0.5% for oropharyngeal and dipotassium glycyrrhizinate 2.5 mg/ml plus PVI 0.5% for nasal spray. Patients were advised to concomitantly use oropharyngeal and nasal sprays 6 times per day. They were instructed to abstain from food, drink, and smoke for 20min, particularly after oropharyngeal spray. The oropharyngeal spray bottle contains an atomizer that ends with a long arm applicator to insert inside the mouth cavity and can be directed up, down, right, or left to cover the entire pharyngeal area.
Targeted administration to the respiratory tract provides treatment directly to the typical source of initial SARS-CoV-2 infection and replication, and allows for rapid onset of action, higher local drug concentration, and reduced systemic side effects.
risk of hospitalization, 90.9% lower, RR 0.09, p = 0.06, treatment 0 of 100 (0.0%), control 5 of 100 (5.0%), NNT 20, relative risk is not 0 because of continuity correction due to zero events (with reciprocal of the contrasting arm).
recovery time, 14.6% lower, relative time 0.85, p = 0.008, treatment mean 7.6 (±2.0) n=100, control mean 8.9 (±2.0) n=100.
recovery time, 49.1% lower, relative time 0.51, p < 0.001, treatment mean 5.6 (±1.3) n=100, control mean 11.0 (±3.4) n=100, smell.
recovery time, 48.2% lower, relative time 0.52, p < 0.001, treatment mean 5.7 (±1.0) n=100, control mean 11.0 (±4.0) n=100, taste.
risk of no viral clearance, 67.7% lower, RR 0.32, p < 0.001, treatment 21 of 100 (21.0%), control 65 of 100 (65.0%), NNT 2.3, mid-recovery, day 7.
risk of no viral clearance, 90.0% lower, RR 0.10, p = 0.010, treatment 1 of 100 (1.0%), control 10 of 100 (10.0%), NNT 11, day 10.
risk of no viral clearance, 29.3% lower, RR 0.71, p < 0.001, treatment 70 of 100 (70.0%), control 99 of 100 (99.0%), NNT 3.4, day 4.
risk of transmission, 91.9% lower, RR 0.08, p < 0.001, treatment 12 of 194 (6.2%), control 173 of 227 (76.2%), NNT 1.4, symptomatic.
risk of transmission, 94.0% lower, RR 0.06, p < 0.001, treatment 8 of 194 (4.1%), control 157 of 227 (69.2%), NNT 1.5, PCR+.
Effect extraction follows pre-specified rules prioritizing more serious outcomes. Submit updates
Elsersy et al., 19 Apr 2022, Double Blind Randomized Controlled Trial, placebo-controlled, Egypt, peer-reviewed, 8 authors, study period March 2021 - July 2021, this trial uses multiple treatments in the treatment arm (combined with glycyrrhizic acid) - results of individual treatments may vary, trial PACTR202101875903773. Contact: hazelsersy@hotmail.com, hazem.anwar@med.menofia.edu.eg.
This PaperPovidone-Iod..All
Combined Nasal, Oropharyngeal Povidone Iodine Plus Glycyrrhizic Acid Sprays, Accelerate Clinical and Laboratory Recovery and Reduces Household Transmission of SARS-CoV-2: A Randomized Placebo-Controlled Clinical Trial
Hazem E Elsersy, Magdy A H Zahran, Abd-Elazeem Elbakry, Mohamed Abd-Elwahab, Mohamed Milegy Ahmed, Mohamed Salah Elgandy, Eman H M Mohammed, Nourhan M Elewa
Frontiers in Medicine, doi:10.3389/fmed.2022.863917
The COVID-19 pandemic is still posing challenging health and economic problems. Effective broad-spectrum antiviral therapy is urgently needed for the control of early SARS-CoV-2 infection to limit its spread and mutations. In this randomized placebocontrolled clinical study, we tested the effects of intranasal and oropharyngeal delivery of a compound of povidone-iodine 0.5% and glycyrrhizic acid 2.5 mg/ml on the laboratory (PCR) and clinical recovery from SARS-CoV-2 patients and their household contacts. 353 patients suspected of having COVID-19 infection were screened by chest CT and nasopharyngeal swab tests (PCR). 200 patients were randomly allocated to two equal groups: treatment and placebo groups. Treatment accelerated the recovery of PCR on days 4, 7, and 10, as evidenced by PCR-positive patients (70, vs. 99%, 20 vs. 65%, 1 vs. 10%) in both the treated and placebo groups, respectively. Treatment enhanced the early recovery of symptoms [day 7.6 ± 2 (CI 7:8.3) vs. 8.9 ± 2 (CI 8.3:9.6)]. Treatment promoted early recovery of anosmia and ageusia [5.6 ± 1 (CI, 4.8:6.4) vs. 11 ± 3 days, (CI, 10.8:12)] in both the treated and control groups (P < 0.0001). There was a notable reduction in transmission of the virus among the household close contacts in the treatment group (4%) vs. 76% in the placebo group. Combined PVI-GA nasal and oropharyngeal spray accelerates both laboratory and clinical recovery of SARS-CoV-2 infected patients in the early phases of the disease and reduces the household spread of the virus; thus, it may play an important role in controlling coronavirus outbreaks. Clinical Trial Registration: https://pactr.samrc.ac.za, PACTR202101875903773.
ETHICS STATEMENT The studies involving human participants were reviewed and approved by Fever and Liver Hospital Local Ethics Committee. Written informed consent to participate in this study was provided by the patients/participants or their legal guardian/next of kin. AUTHOR CONTRIBUTIONS HE: Idea, intellectual property, protocol design, experimental design, data analysis, manuscript writing, pilot 1, and pilot 2 design and conduction. MZ: Data analysis, manuscript writing, extraction, and purification of Glycyrrhizic acid and its salts. A-EE: Experimental design, data analysis, manuscript writing, randomization, and allocation. MA-E: Experimental design, data analysis, Manuscript writing, design, and conduction of pilot 3. MA: Data analysis, Manuscript writing design, and conduction of pilot 4. ME: Data analysis, manuscript writing, and case report conduction. EM and NE: Data analysis, Manuscript writing, Glycyrrhizic acid, and its salts extraction. All authors contributed to the article and approved the submitted version. FUNDING The present study was funded by donations from Elsersy Scientific Med. company. SUPPLEMENTARY MATERIAL The Supplementary Material for this article can be found online at: https://www.frontiersin.org/articles/10.3389/fmed. 2022.863917/full#supplementary-material Conflict of Interest: This project has been filed as a patent application for HE, international PCT PCT/EG/2021000030, national application number 2020/1599. The remaining authors..
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Adv', 'author': 'Brann', 'year': '2020', 'DOI': '10.1126/sciadv.abc5801'}, { 'key': 'B22', 'doi-asserted-by': 'publisher', 'first-page': '2774', 'DOI': '10.1021/acschemneuro.0c00447', 'article-title': 'Taste and smell disorders in COVID-19 patients. role of interleukin-6', 'volume': '11', 'author': 'Cazzolla', 'year': '2020', 'journal-title': 'ACS Chem Neurosci.'}, { 'key': 'B23', 'doi-asserted-by': 'publisher', 'first-page': '310', 'DOI': '10.1016/j.apsb.2015.05.005', 'article-title': 'The antiviral and antimicrobial activities of licorice, a widely-used ' 'Chinese herb', 'volume': '5', 'author': 'Wang', 'year': '2015', 'journal-title': 'Acta Pharm Sin B.'}, { 'key': 'B24', 'doi-asserted-by': 'publisher', 'first-page': '260', 'DOI': '10.1016/j.ijsu.2017.06.073', 'article-title': 'Povidone iodine in wound healing: a review of current concepts and ' 'practices', 'volume': '44', 'author': 'Bigliardi', 'year': '2017', 'journal-title': 'Int J Surg'}, { 'key': 'B25', 'doi-asserted-by': 'publisher', 'first-page': '434', 'DOI': '10.1191/096032700682694251', 'article-title': 'Glycyrrhizic acid: the assessment of a no effect level', 'volume': '19', 'author': 'van Gelderen', 'year': '2000', 'journal-title': 'Hum Exp Toxicol.'}, { 'key': 'B26', 'article-title': 'Final report on the safety assessment of glycyrrhetinic acid, potassium ' 'glycyrrhetinate, disodium succinoyl glycyrrhetinate, glyceryl ' 'glycyrrhetinate, glycyrrhetinyl stearate, stearyl glycyrrhetinate, ' 'glycyrrhizic acid, ammonium glycyrrhizate, dipotassium glycyrrhizate, ' 'disodium glycyrrhizate, trisodium glycyrrhizate, methyl glycyrrhizate, ' 'and potassium glycyrrhizinate', 'volume-title': 'Int J Toxicol', 'year': '2007'}, { 'key': 'B27', 'doi-asserted-by': 'publisher', 'first-page': 'e002794', 'DOI': '10.1136/bmjgh-2020-002794', 'article-title': 'Reduction of secondary transmission of SARS-CoV-2 in households by face ' 'mask use, disinfection and social distancing: a cohort study in ' 'Beijing, China', 'volume': '5', 'author': 'Wang', 'year': '2020', 'journal-title': 'BMJ Global Health.'}, { 'key': 'B28', 'article-title': 'Virological assessment of hospitalized patients with COVID-2019', 'volume-title': 'Nature.', 'author': 'Wölfel', 'year': '2020'}, { 'key': 'B29', 'doi-asserted-by': 'publisher', 'first-page': '672', 'DOI': '10.1038/s41591-020-0869-5', 'article-title': 'Temporal dynamics in viral shedding and transmissibility of COVID-19', 'volume': '26', 'author': 'He', 'year': '2020', 'journal-title': 'Nat Med.'}], 'container-title': 'Frontiers in Medicine', 'original-title': [], 'link': [ { 'URL': 'https://www.frontiersin.org/articles/10.3389/fmed.2022.863917/full', 'content-type': 'unspecified', 'content-version': 'vor', 'intended-application': 'similarity-checking'}], 'deposited': { 'date-parts': [[2022, 4, 20]], 'date-time': '2022-04-20T02:10:12Z', 'timestamp': 1650420612000}, 'score': 1, 'resource': {'primary': {'URL': 'https://www.frontiersin.org/articles/10.3389/fmed.2022.863917/full'}}, 'subtitle': [], 'short-title': [], 'issued': {'date-parts': [[2022, 4, 19]]}, 'references-count': 29, 'alternative-id': ['10.3389/fmed.2022.863917'], 'URL': 'http://dx.doi.org/10.3389/fmed.2022.863917', 'relation': {}, 'ISSN': ['2296-858X'], 'subject': ['General Medicine'], 'container-title-short': 'Front. Med.', 'published': {'date-parts': [[2022, 4, 19]]}}
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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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