Efficacy of Iodine Complex Against COVID-19 Patients (I-COVID-PK)

Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients

The objective of this study is to measure the effect of Iodine complex in treating the COVID-19 patients to clear viral load of SARS-CoV-2 along with reduction in severity of symptoms and length of hospitalization of patients with COVID-19.

Study Overview

• Status: Recruiting
• Conditions: Covid19; Corona Virus Infection; SARS-CoV-2
• Intervention / Treatment: Drug: Iodine Complex; Drug: Iodine Complex; Drug: Placebo; Drug: Idoine Complex

Detailed Description

The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a close-label and adaptive, multi-centered design with 1:1:1:1 allocation ratio and superiority framework.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Sohaib Ashraf, MBBS; Phone Number: +923334474523; Email: sohaib-ashraf@outlook.com
• Study Contact Backup: Name: Shoaib Ashraf, PhD; Phone Number: +16177949579; Email: sashraf@mgh.harvard.edu

Study Locations

• Pakistan
  • Lahore, Pakistan, 54600
    • Recruiting
    • Shaikh Zayed Hospital
    • Contact: Muhammad Ahmad Imran, MBBS; Phone Number: +923338110708; Email: ahmad.ammy93@gmail.com
    • Principal Investigator: Muhammad Ahmad Imran, MBBS
    • Contact: Sohaib Ashraf, MBBS; Phone Number: +923334474523; Email: sohaib@skzmdc.edu.pk
    • Sub-Investigator: Uzma Nasim, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Positive PCR with mild to moderate disease

Exclusion Criteria:

• Allergic to iodine
• Any co-morbidity other than hypertension and dietetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iodine Complex (Capsule form); Iodine Complex) capsule (200mg) will be given three times a day	Drug: Iodine Complex; Iodine Complex capsule (200mg) will be given three times a day; Drug: Iodine Complex; Iodine Complex syrup form (40ml) will be given three times a day
Experimental: Iodine Complex (Syrup form); Iodine Complex syrup form (40ml) will be given three times a day	Drug: Iodine Complex; Iodine Complex capsule (200mg) will be given three times a day; Drug: Iodine Complex; Iodine Complex syrup form (40ml) will be given three times a day
Placebo Comparator: Standard Care Alone; Placebo as empty capsule. Treatment will be given for all 4 arms will be receiving standard care as per version 3.0 of clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan COVID-19 guidelines of the study setting.	Drug: Placebo; Empty capsule will be given as placebo; Other Names: capsule
Experimental: Iodine Complex (Nasal Spray); Iodine complex throat spray of 2 puffs three times a day.	Drug: Idoine Complex; Iodine Complex spray form 2 puffs will be given three times a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
qRT-PCR	Time taken for viral load clearance	14 days
HRCT chest	Time taken for radiological improvement	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of Symptoms	Time taken for symptomatic response in patients	14 days

Collaborators and Investigators

• Sponsor: Sohaib Ashraf
• Investigators: Principal Investigator: Sohaib Ashraf, MBBS, Shaikh Zayed Medical Complex, Pakistan; Principal Investigator: Moneeb Ashraf, MBBS, Mayo Hospital, Pakistan; Study Chair: Muhammad Ashraf, PhD, University of Veterinary & Animal Sciences, Pakistan; Study Director: Shoaib Ashraf, PhD, Harvard University, Massachusetts General Hospital, Boston, USA

Publications and helpful links

General Publications

• Ashraf S, Ashraf S, Ashraf M, Imran MA, Kalsoom L, Siddiqui UN, Farooq I, Ghufran M, Khokhar RA, Akram MK, Shahid I, Sohaib Ur Rehman M, Akmal R, Tahir A, Zahid A, Ashraf S, Rafique S, Matti N, Nadeem MF, Humayun A, Malik A, Saboor QA, Ahmad A, Ashraf M, Izhar M. A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial. Trials. 2021 Feb 10;22(1):127. doi: 10.1186/s13063-021-05081-3.

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2020
• Primary Completion (Anticipated): August 15, 2021
• Study Completion (Anticipated): October 15, 2021

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 7, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Coronavirus; COVID-19; SARS-Cov-2; Iodine Complex
• Additional Relevant MeSH Terms: Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Coronavirus Infections; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Trace Elements; Micronutrients; Iodine; Cadexomer iodine
• Other Study ID Numbers: SZMC/IRB/Internal/216/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No