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 Sohaib , Ashraf Shoaib , Ashraf Moneeb , Farooq Iqra , Akmal Rutaba , Imran Muhammad Ahmad , Kalsoom Larab , Ashraf Sidra , Rafique Sundas , Ghufran Muhammad , Akram Muhammad Kiwan , Sohaib-ur-Rehman  , Nadeem Muhammad Faisal , Matti Nazish , Siddiqui Uzma Nasim , Humayun Ayesha , Saboor Qazi Abdul , Ahmad Ali , Ashraf Muhammad , Izhar Mateen ,   DOCTORS LOUNGE consortium, Habib Zaigham , Hayat Kanwal , Amjad Ghazala , Kousar Misbah , Arshad Shahroze , Hafeez Umair , Mughal Tayyab , Saleem Muhammad Sikandar , Ahmad Ammara , Awais Abeer bin , Khalid Noman , Iqbal Qurat-ul-Ain , Hassan Muhammad , Virk Abdul Rehman , Gul Mehak , Naeem Muhammad Tayyab , Umer Roa , Khalil Musa , Muzafar Tayyaba , Zulfiqar Sibgha , Alam Saadia Shahzad , Chohan Emed , Anwar Muhammad Imran , Mirza Ali Rafique , Malik Amber , Mahmud Talha , Akmal Adeen , Sherazi Syed Sami Husain , Safdar Zartasha , Ahmad Sohail , Arshad Ali , Nawaz Khawar , Yousaf Muhammad Ismail Khalid , Zahid Muhammad Nauman 
Published: January 2022

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.govNCT04473261. Registered on July 16, 2020.