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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