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0 0.5 1 1.5 2+ 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% Elsersy et al. PACTR202101875903773 Povidone-Iodine RCT EARLY Is early treatment with povidone-iodine+glycyrrhizic acid beneficial for COVID-19? Double-blind RCT 421 patients in Egypt (March - July 2021) Faster recovery (p=0.008) and improved viral clearance (p<0.0001) Elsersy et al., Frontiers in Medicine, doi:10.3389/fmed.2022.863917 Favors povidone-iodine Favors control
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
Elsersy et al., Combined Nasal, Oropharyngeal Povidone Iodine Plus Glycyrrhizic Acid Sprays, Accelerate Clinical and.., Frontiers in Medicine, doi:10.3389/fmed.2022.863917, PACTR202101875903773
Apr 2022   Source   PDF  
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RCT with 200 patients and 421 contacts in Egypt, 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.
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+.
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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.
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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
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:, 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: 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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