Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial.
| Title: | Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial. |
|---|---|
| Authors: | Ashraf S; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. sohaib@skzmdc.edu.pk.; Ashraf S; Department of Pathophysiology, Riphah International, Lahore, Pakistan. shoaib.ashraf@mail.mcgill.ca.; Ashraf M; Department of Pharmacology, Mayo Hospital, Kingedward Medical University, Lahore, Pakistan. moneeb-ashraf@hotmail.com.; Farooq I; Department of Paediatric Surgery, Children Hospital, Lahore, Pakistan.; Akmal R; Department of Medicine, Sahara Medical College, Narowal, Pakistan.; Imran MA; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Kalsoom L; Department of Medicine, Services Institute of Medical Sciences, Lahore, Pakistan.; Ashraf S; Department of Biochemistry, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Rafique S; Department of Oncology, Mayo Hospital, Kingedward Medical University, Lahore, Pakistan.; Ghufran M; ESACHS (Empresa de Servicio Externo de la Asociación Chilena de Seguridad), Santiago, Chile.; Akram MK; Department of Animal Nutrition, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Sohaib-Ur-Rehman; Department of Community Medicine, Shaikh Khalifa Bin Zayed Al-Nahyan Medical and Dental College, Lahore, Pakistan.; Nadeem MF; The University of Strasbourg, Alsace, France.; University of Veterinary and Animal Sciences, Lahore, Pakistan.; Matti N; Department of Pharmacy, Quaid-i-Azam University, Islamabad, Pakistan.; Siddiqui UN; Department of Medicine, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Humayun A; Department of Community Medicine, Shaikh Khalifa Bin Zayed Al-Nahyan Medical and Dental College, Lahore, Pakistan.; Saboor QA; Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan.; Ahmad A; Department of Microbiology, Infectiology and Immunology, Centre Hospitalier Universitaire (CHU) Sainte Justin/University of Montreal, Montreal, Canada. ali.ahmad@recherche-ste-justine.qc.ca.; Ashraf M; Department of Pharmacology and Toxicology, University of Veterinary and Animal Sciences, Lahore, Pakistan.; Izhar M; Department of Microbiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. |
| Corporate Authors: | DOCTORS LOUNGE consortium |
| Source: | Trials [Trials] 2022 Jan 19; Vol. 23 (1), pp. 58. Date of Electronic Publication: 2022 Jan 19. |
| Publication Type: | Clinical Trial Protocol; Journal Article |
| Language: | English |
| Journal Info: | Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE |
| Imprint Name(s): | Original Publication: [London] : BioMed Central, 2006- |
| MeSH Terms: | COVID-19* ; Iodine*; Humans ; Pandemics ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Treatment Outcome ; Equivalence Trials as Topic |
| Abstract: | Background: Coronavirus disease 2019 (COVID-19) caused by the novel coronavirus-infected millions globally. Despite a wide range of advised options for the treatment of COVID-19, a single strategy to tackle this pandemic remains elusive, thus far. That is why we are conducting a clinical trial to find out the efficacy of iodine complex to clear a viral load of severe respiratory syndrome coronavirus-2 (SARS-CoV-2) along with a reduction in time taken to alleviate symptoms.; Method: The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a closed-label and adaptive with sample size reassessment, multi-centered design with a 1:1:1:1 allocation ratio and superiority framework. It will be conducted in Shaikh Zayed Post-Graduate Medical Complex, Ali Clinic, and Doctors Lounge, Lahore, Pakistan. This study will have three arms of mild to moderately symptomatic COVID-19 patients (50 patients in each) which will receive ionic-iodine polymer complex with 200 mg of elemental iodine: interventional arm A will have encapsulated, arm B will receive suspension syrup form, arm C will get throat spray, while arm X will be standard care with placebo. Data will be collected on self-constructed, close-ended questionnaires after obtaining written consent. Data will be analyzed using SAS version 9.4. COVID-19 patients will be monitored by RT-PCR and HRCT (high-resolution computed tomography) chest. In addition to these, the duration of the symptomatic phase and mortality benefits will be analyzed in both groups.; Discussion: The study is designed to measure the superior efficacy of the iodine complex as an add-on in treating COVID-19-positive patients with mild to moderate symptoms. This combination is hypothesized to improve various parameters like rapid viral load reduction, clinical and radiological improvement, lower mortality, and reduction in hospitalization. The trial will aid in devising a better strategy to cope with COVID-19 in a relatively inexpensive and accessible way. The implications are global, and this could prove itself to be the most manageable intervention against COVID-19 especially for patients from limited-resource countries with deprived socioeconomic status.; Trial Registration: ClinicalTrials.gov NCT04473261 . Registered on July 16, 2020.; (© 2022. The Author(s).) |
| References: | J Laryngol Otol. 2015 Jan;129 Suppl 1:S45-50. (PMID: 25363372); Virol J. 2009 Aug 13;6:124. (PMID: 19678928); Arch Microbiol. 2021 Sep;203(7):4743-4749. (PMID: 34136927); Nutrients. 2017 Oct 05;9(10):. (PMID: 28981457); Eur Radiol. 2020 Dec;30(12):6808-6817. (PMID: 32623505); Ear Nose Throat J. 2021 Apr;100(2_suppl):192S-196S. (PMID: 32951446); Dermatology. 2006;212 Suppl 1:119-23. (PMID: 16490989); Radiology. 2011 Jul;260(1):18-39. (PMID: 21697307); Clin Nutr. 2016 Feb;35(1):183-189. (PMID: 25703452); Dermatology. 2002;204 Suppl 1:114-20. (PMID: 12011534); Trials. 2021 Feb 10;22(1):127. (PMID: 33568226); Biomed Res Int. 2013;2013:597282. (PMID: 23781504); Radiographics. 2018 May-Jun;38(3):719-739. (PMID: 29757717); Acta Endocrinol (Copenh). 1990 Nov;123(5):531-4. (PMID: 1979466); Eur J Clin Pharmacol. 1980 Jan;17(1):19-23. (PMID: 6966220); Infect Dis Ther. 2018 Jun;7(2):249-259. (PMID: 29633177); Med Hypotheses. 2020 Nov;144:109860. (PMID: 32540604); Int J Infect Dis. 2005 Sep;9(5):292-3. (PMID: 16046271); Clin Pharmacol Ther. 2012 Sep;92(3):294-305. (PMID: 22850602); Radiology. 2020 Jun;295(3):715-721. (PMID: 32053470); JAMA Otolaryngol Head Neck Surg. 2020 Nov 1;146(11):1054-1058. (PMID: 32940656) |
| Contributed Indexing: | Investigator: Z Habib; K Hayat; G Amjad; M Kousar; S Arshad; U Hafeez; T Mughal; MS Saleem; A Ahmad; AB Awais; N Khalid; QU Iqbal; M Hassan; AR Virk; M Gul; MT Naeem; R Umer; M Khalil; T Muzafar; S Zulfiqar; SS Alam; E Chohan; MI Anwar; AR Mirza; A Malik; T Mahmud; A Akmal; SSH Sherazi; Z Safdar; S Ahmad; A Arshad; K Nawaz; MIK Yousaf; MN Zahid; Keywords: COVID-19; Iodine; SARS-CoV-2 |
| Molecular Sequence: | ClinicalTrials.gov NCT04473261 |
| Substance Nomenclature: | 9679TC07X4 (Iodine) |
| Entry Date(s): | Date Created: 20220120 Date Completed: 20220121 Latest Revision: 20260109 |
| Update Code: | 20260130 |
| PubMed Central ID: | PMC8767036 |
| DOI: | 10.1186/s13063-021-05848-8 |
| PMID: | 35045888 |
| Database: | MEDLINE |
Clinical Trial Protocol; Journal Article