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Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol
Sohaib Ashraf1, Shoaib Ashraf2, Moneeb Ashraf3
1Department of Cardiology, Shaikh Zayed Post-Graduate Medical Institute, Lahore, Pakistan. sohaib@skzmdc.edu.pk.
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.
Insights
This clinical trial investigates an iodine complex for treating COVID-19, aiming to reduce viral load and symptom duration. The study hypothesizes that this intervention offers an accessible and inexpensive strategy for managing coronavirus disease 2019.
Area of Science:
- Infectious Diseases
- Virology
- Clinical Trials
Background:
- The COVID-19 pandemic caused by SARS-CoV-2 has led to millions of infections globally.
- Existing treatments for COVID-19 lack a universally effective strategy.
- This study explores a novel therapeutic approach for managing coronavirus disease 2019.
Purpose of the Study:
- To evaluate the efficacy of an iodine complex as an add-on therapy for mild to moderate COVID-19.
- To determine if the iodine complex can reduce viral load and shorten symptom duration in SARS-CoV-2 infected patients.
- To assess the potential of this intervention to lower mortality and hospitalization rates.
Main Methods:
- A placebo-controlled, randomized, parallel-group trial with a 1:1:1:1 allocation ratio.
- Three intervention arms receiving different forms of an ionic-iodine polymer complex (encapsulated, suspension, throat spray) alongside standard care.
- Standard care with placebo as the control arm, with data collected via questionnaires and analyzed using SAS 9.4.
- Patient monitoring through RT-PCR and HRCT chest, analyzing symptomatic phase duration and mortality benefits.
Main Results:
- The study is designed to measure the superior efficacy of the iodine complex.
- Hypothesized improvements include rapid viral load reduction, clinical and radiological enhancement, and decreased mortality.
- The trial aims to provide data on the effectiveness of iodine complex in managing COVID-19 symptoms and outcomes.
Conclusions:
- The iodine complex shows potential as an effective add-on treatment for COVID-19 patients with mild to moderate symptoms.
- This intervention is hypothesized to offer a cost-effective and accessible strategy for managing the pandemic.
- The findings could have global implications, particularly for resource-limited settings, providing a manageable intervention against SARS-CoV-2.
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