NCT04473261

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_1 covid19

Timeline
Completed

Started Jul 2020

Typical duration for phase_1 covid19

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 14, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

July 14, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2021

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

1.1 years

First QC Date

July 14, 2020

Last Update Submit

July 4, 2021

Conditions

Covid19SARS-CoV-2Corona Virus Infection

Keywords

SARS-Cov-2COVID-19CoronavirusIodine Complex

Outcome Measures

Primary Outcomes (2)

  • qRT-PCR

    Time taken for viral load clearance

    14 days

  • HRCT chest

    Time taken for radiological improvement

    14 days

Secondary Outcomes (1)

  • Severity of Symptoms

    14 days

Study Arms (4)

Iodine Complex (Capsule form)

EXPERIMENTAL

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

Drug: Iodine Complex

Iodine Complex (Syrup form)

EXPERIMENTAL

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

Drug: Iodine Complex

Standard Care Alone

PLACEBO COMPARATOR

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

Iodine Complex (Nasal Spray)

EXPERIMENTAL

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

Drug: Idoine Complex

Interventions

Iodine ComplexDRUG

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

Iodine Complex (Capsule form)
PlaceboDRUG

Empty capsule will be given as placebo

Also known as: capsule
Standard Care Alone
Idoine ComplexDRUG

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

Iodine Complex (Nasal Spray)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Positive PCR with mild to moderate disease

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital

Lahore, 54600, Pakistan

RECRUITING

Related Publications (2)

  • Ashraf S, Ashraf S, Ashraf M, Farooq I, Akmal R, Imran MA, Kalsoom L, Ashraf S, Rafique S, Ghufran M, Akram MK, Sohaib-Ur-Rehman, Nadeem MF, Matti N, Siddiqui UN, Humayun A, Saboor QA, Ahmad A, Ashraf M, Izhar M; DOCTORS LOUNGE consortium. Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial. Trials. 2022 Jan 19;23(1):58. doi: 10.1186/s13063-021-05848-8.

    PMID: 35045888DERIVED

  • 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.

    PMID: 33568226DERIVED

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Capsules

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Study Officials

  • Muhammad Ashraf, PhD

    University of Veterinary & Animal Sciences, Pakistan

    STUDY CHAIR

  • Shoaib Ashraf, PhD

    Harvard University, Massachusetts General Hospital, Boston, USA

    STUDY DIRECTOR

  • Moneeb Ashraf, MBBS

    Mayo Hospital, Pakistan

    PRINCIPAL INVESTIGATOR

  • Sohaib Ashraf, MBBS

    Shaikh Zayed Medical Complex, Pakistan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sohaib Ashraf, MBBS

CONTACT

+923334474523sohaib-ashraf@outlook.com

Shoaib Ashraf, PhD

CONTACT

+16177949579sashraf@mgh.harvard.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
empty capsule will be given as a placebo
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized, controlled, multi-armed, close-label, interventional study designed
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Post-Graduate Resident Cardiology

Study Record Dates

First Submitted

July 14, 2020

First Posted

July 16, 2020

Study Start

July 14, 2020

Primary Completion

August 15, 2021

Study Completion

October 15, 2021

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations

PA(1)