Efficacy of Iodine Complex Against COVID-19 Patients

NCT ID: NCT04473261

Last Updated: 2021-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-14

Study Completion Date

2021-10-15

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.

Conditions

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Covid19 SARS-CoV-2 Corona Virus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, multi-armed, close-label, interventional study designed
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
empty capsule will be given as a placebo

Study Groups

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Iodine Complex (Capsule form)

Iodine Complex) capsule (200mg) will be given three times a day

Group Type EXPERIMENTAL

Iodine Complex

Intervention Type DRUG

Iodine Complex capsule (200mg) will be given three times a day

Iodine Complex (Syrup form)

Iodine Complex syrup form (40ml) will be given three times a day

Group Type EXPERIMENTAL

Iodine Complex

Intervention Type DRUG

Iodine Complex syrup form (40ml) will be given three times a day

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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Empty capsule will be given as placebo

Iodine Complex (Nasal Spray)

Iodine complex throat spray of 2 puffs three times a day.

Group Type EXPERIMENTAL

Idoine Complex

Intervention Type DRUG

Iodine Complex spray form 2 puffs will be given three times a day

Interventions

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Iodine Complex

Iodine Complex capsule (200mg) will be given three times a day

Intervention Type DRUG

Iodine Complex

Iodine Complex syrup form (40ml) will be given three times a day

Intervention Type DRUG

Placebo

Empty capsule will be given as placebo

Intervention Type DRUG

Idoine Complex

Iodine Complex spray form 2 puffs will be given three times a day

Intervention Type DRUG

Other Intervention Names

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capsule

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohaib Ashraf

OTHER

Sponsor Role lead

Responsible Party

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Sohaib Ashraf

Post-Graduate Resident Cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Muhammad Ashraf, PhD

Role: STUDY_CHAIR

University of Veterinary & Animal Sciences, Pakistan

Shoaib Ashraf, PhD

Role: STUDY_DIRECTOR

Harvard University, Massachusetts General Hospital, Boston, USA

Moneeb Ashraf, MBBS

Role: PRINCIPAL_INVESTIGATOR

Mayo Hospital, Pakistan

Sohaib Ashraf, MBBS

Role: PRINCIPAL_INVESTIGATOR

Shaikh Zayed Medical Complex, Pakistan

Locations

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Shaikh Zayed Hospital

Lahore, , Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Sohaib Ashraf, MBBS

Role: CONTACT

+923334474523

Shoaib Ashraf, PhD

Role: CONTACT

+16177949579

Facility Contacts

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Sohaib Ashraf, MBBS

Role: primary

+923334474523

Muhammad Ahmad Imran, MBBS

Role: backup

+923338110708

References

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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.

Reference Type DERIVED
PMID: 33568226 (View on PubMed)

Other Identifiers

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SZMC/IRB/Internal/216/2020

Identifier Type: -

Identifier Source: org_study_id

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