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

Primary Purpose

Covid19, SARS-CoV-2, Corona Virus Infection

Status

Unknown status

Phase

Phase 1

Locations

Pakistan

Study Type

Interventional

Intervention

Iodine Complex

Placebo

Idoine Complex

About this trial

This is an interventional treatment trial for Covid19 focused on measuring SARS-Cov-2, COVID-19, Coronavirus, Iodine Complex

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Positive PCR with mild to moderate disease

Exclusion Criteria:

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

Sites / Locations

Shaikh Zayed HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Iodine Complex (Capsule form)

Iodine Complex (Syrup form)

Standard Care Alone

Iodine Complex (Nasal Spray)

Arm Description

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

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

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.

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

Outcomes

Primary Outcome Measures

qRT-PCR

Time taken for viral load clearance

HRCT chest

Time taken for radiological improvement

Secondary Outcome Measures

Severity of Symptoms

Time taken for symptomatic response in patients

Full Information

NCT ID

NCT04473261

First Posted

July 14, 2020

Last Updated

July 4, 2021

Sponsor

Sohaib Ashraf

1. Study Identification

Unique Protocol Identification Number

NCT04473261

Brief Title

Efficacy of Iodine Complex Against COVID-19 Patients

Acronym

I-COVID-PK

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Unknown status

Study Start Date

July 14, 2020 (Actual)

Primary Completion Date

August 15, 2021 (Anticipated)

Study Completion Date

October 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sohaib Ashraf

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Covid19, SARS-CoV-2, Corona Virus Infection

Keywords

SARS-Cov-2, COVID-19, Coronavirus, Iodine Complex

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Randomized, controlled, multi-armed, close-label, interventional study designed

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

empty capsule will be given as a placebo

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Iodine Complex (Capsule form)

Arm Type

Experimental

Arm Description

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

Arm Title

Iodine Complex (Syrup form)

Arm Type

Experimental

Arm Description

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

Arm Title

Standard Care Alone

Arm Type

Placebo Comparator

Arm Description

Arm Title

Iodine Complex (Nasal Spray)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Iodine Complex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Iodine Complex

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

capsule

Intervention Description

Empty capsule will be given as placebo

Intervention Type

Drug

Intervention Name(s)

Idoine Complex

Intervention Description

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

Primary Outcome Measure Information:

Title

qRT-PCR

Description

Time taken for viral load clearance

Time Frame

14 days

Title

HRCT chest

Description

Time taken for radiological improvement

Time Frame

14 days

Secondary Outcome Measure Information:

Title

Severity of Symptoms

Description

Time taken for symptomatic response in patients

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sohaib Ashraf, MBBS

Phone

+923334474523

sohaib-ashraf@outlook.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shoaib Ashraf, PhD

Phone

+16177949579

sashraf@mgh.harvard.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Muhammad Ashraf, PhD

Organizational Affiliation

University of Veterinary & Animal Sciences, Pakistan

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Shoaib Ashraf, PhD

Organizational Affiliation

Harvard University, Massachusetts General Hospital, Boston, USA

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Moneeb Ashraf, MBBS

Organizational Affiliation

Mayo Hospital, Pakistan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sohaib Ashraf, MBBS

Organizational Affiliation

Shaikh Zayed Medical Complex, Pakistan

Official's Role

Principal Investigator

Facility Information:

Facility Name

Shaikh Zayed Hospital

City

Lahore

ZIP/Postal Code

54600

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sohaib Ashraf, MBBS

Phone

+923334474523

sohaib@skzmdc.edu.pk

First Name & Middle Initial & Last Name & Degree

Muhammad Ahmad Imran, MBBS

Phone

+923338110708

ahmad.ammy93@gmail.com

First Name & Middle Initial & Last Name & Degree

Muhammad Ahmad Imran, MBBS

First Name & Middle Initial & Last Name & Degree

Uzma Nasim, FCPS

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

33568226

Citation

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.

Results Reference

derived

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Efficacy of Iodine Complex Against COVID-19 Patients

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