Efficacy of Iodine Complex Against COVID-19 Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Covid19, SARS-CoV-2, Corona Virus Infection

Intervention / Treatment
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* Drug: Iodine Complex
* Drug: Iodine Complex
* Drug: Placebo
* Drug: Idoine Complex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive PCR with mild to moderate disease Exclusion Criteria: Allergic to iodine Any co-morbidity other than hypertension and dietetics

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, multi-armed, close-label, interventional study designed
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iodine Complex (Capsule form)<br>Iodine Complex) capsule (200mg) will be given three times a day | Drug: Iodine Complex<br>* Iodine Complex capsule (200mg) will be given three times a day<br>|
| Experimental: Iodine Complex (Syrup form)<br>Iodine Complex syrup form (40ml) will be given three times a day | Drug: Iodine Complex<br>* Iodine Complex syrup form (40ml) will be given three times a day<br>|
| Placebo Comparator: Standard Care Alone<br>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<br>* Empty capsule will be given as placebo<br>* Other names: capsule;|
| Experimental: Iodine Complex (Nasal Spray)<br>Iodine complex throat spray of 2 puffs three times a day. | Drug: Idoine Complex<br>* Iodine Complex spray form 2 puffs will be given three times a day<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SARS-Cov-2, COVID-19, Coronavirus, Iodine Complex