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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
Sponsor:
Information provided by (Responsible Party):
Sohaib Ashraf, Sheikh Zayed Federal Postgraduate Medical Institute

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.

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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

Drug Information available for: Iodine

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




Primary Outcome Measures :
  1. qRT-PCR [ Time Frame: 14 days ]
    Time taken for viral load clearance

  2. HRCT chest [ Time Frame: 14 days ]
    Time taken for radiological improvement


Secondary Outcome Measures :
  1. Severity of Symptoms [ Time Frame: 14 days ]
    Time taken for symptomatic response in patients



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

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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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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Coronavirus Infections
Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Iodine
Cadexomer iodine
Anti-Infective Agents, Local
Anti-Infective Agents
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs