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

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ClinicalTrials.gov Identifier: NCT04473261

Recruitment Status : Recruiting

First Posted : July 16, 2020

Last Update Posted : July 7, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Covid19 SARS-CoV-2 Corona Virus Infection	Drug: Iodine Complex Drug: Placebo Drug: Idoine Complex	Phase 1 Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	200 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Randomized, controlled, multi-armed, close-label, interventional study designed
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:	empty capsule will be given as a placebo
Primary Purpose:	Treatment
Official Title:	Efficacy of Iodine Complex in Mild to Moderate COVID-19 Patients
Actual Study Start Date :	July 14, 2020
Estimated Primary Completion Date :	August 15, 2021
Estimated Study Completion Date :	October 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019)

Drug Information available for: Iodine

U.S. FDA Resources

Arms and Interventions

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
Experimental: Iodine Complex (Syrup form) Iodine Complex syrup form (40ml) 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 Name: 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

Outcome Measures

Primary Outcome Measures :

qRT-PCR [ Time Frame: 14 days ]
Time taken for viral load clearance
HRCT chest [ Time Frame: 14 days ]
Time taken for radiological improvement

Secondary Outcome Measures :

Severity of Symptoms [ Time Frame: 14 days ]
Time taken for symptomatic response in patients

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Positive PCR with mild to moderate disease

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04473261

Contacts

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Contact: Sohaib Ashraf, MBBS	+923334474523	sohaib-ashraf@outlook.com
Contact: Shoaib Ashraf, PhD	+16177949579	sashraf@mgh.harvard.edu

Locations

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

Sponsors and Collaborators

Sohaib Ashraf

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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Responsible Party:	Sohaib Ashraf, Post-Graduate Resident Cardiology, Sheikh Zayed Federal Postgraduate Medical Institute
ClinicalTrials.gov Identifier:	NCT04473261
Other Study ID Numbers:	SZMC/IRB/Internal/216/2020
First Posted:	July 16, 2020 Key Record Dates
Last Update Posted:	July 7, 2021
Last Verified:	July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute:


SARS-Cov-2 COVID-19 Coronavirus Iodine Complex

Additional relevant MeSH terms:

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COVID-19 Coronavirus Infections Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections	Lung Diseases Respiratory Tract Diseases Iodine Cadexomer iodine Anti-Infective Agents, Local Anti-Infective Agents Trace Elements Micronutrients Physiological Effects of Drugs

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