Efficacy of Subcutaneous Ivermectin With or Without Zinc in COVID-19 Patients (SIZI-COVID-PK)

February 13, 2021 updated by: Sohaib Ashraf

Sub-cutaneous Ivermectin in Combination With and Without Oral Zinc: a Placebo Randomized Control Trial on Mild to Moderate COVID-19 Patients

To measure the effect of Ivermectin (sub-cutaneous) with or without zinc 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a parallel assigned, randomized, controlled, multi-armed, investigator Initiated interventional study is designed to demonstrate efficacy to lower the viral load of COVID-19 and to demonstrate the antiviral effects of subcutaneous Ivermectin with or without zinc in mild to moderate symptomatic patients who consent to randomization following a new diagnosis in Pakistan with COVID-19 (PCR positive). Investigators will follow up with participants daily and PCR will be done on alternate days in BSL-3 lab. Dose will only be repeated if test remained positive..

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Pakistan
    • MA
      • Lahore, MA, Pakistan, 54600
    • Punjab
      • Lahore, Punjab, Pakistan, 54600
        • Recruiting
        • Shaikh Zayed Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammad Ahmad Imran, MBBS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Nasopharyngeal RT-PCR positive SARS-CoV-2 patient with mild to moderate disease
  • Age 18 and above
  • BMI 18-28 kg/m

Exclusion Criteria:

  • Allergy to any drug
  • Co-morbidities: any pre-existing cardiac disease, pulmonary disease
  • Arrhythmias
  • Pregnancy
  • RT-PCR performed >3 days prior to enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Ivermectin alone
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly plus standard care
Drug: Ivermectin Injectable Solution
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Other Names:
  • Montpellier
Drug: Placebo empty capsule
Placebo empty capsule
Active Comparator: Ivermectin with Zinc
Sub-cutaneous injection ivermectin 200ug/kg body weight once every 48 hourly with 20mg Zinc Sulphate 8 hourly plus standard care
Drug: Ivermectin Injectable Solution
Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
Other Names:
  • Montpellier
Drug: Placebo empty capsule
Placebo empty capsule
Drug: Zinc
Zinc Sulphate 20mg 3 times a day
Placebo Comparator: Placebo
Placebo drug plus standard care
Drug: Placebo empty capsule
Placebo empty capsule
Other: Injectable Placebo
0.9% normal saline
Other Names:
  • 0.9% normal saline
Active Comparator: Ivermectin (oral) alone
Oral ivermectin 0.2mg/kg/day
Drug: Placebo empty capsule
Placebo empty capsule
Drug: Oral Ivermectin
0.2mg/kg/day
Active Comparator: Ivermectin (oral) with Zinc
Oral ivermectin 0.2mg/kg/day with 20mg Zinc Sulphate 8 hourly plus standard care
Drug: Placebo empty capsule
Placebo empty capsule
Drug: Zinc
Zinc Sulphate 20mg 3 times a day
Drug: Oral Ivermectin
0.2mg/kg/day
Active Comparator: Zinc Alone
20mg Zinc Sulphate 8 hourly plus standard care
Drug: Placebo empty capsule
Placebo empty capsule
Drug: Zinc
Zinc Sulphate 20mg 3 times a day

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
qRT-PCR
Time Frame: 14 days
time needed to turn positive COVID-19 PCR to negative
14 days
Time taken for alleviation of symptoms
Time Frame: upto 14 days
time needed to turn off symptoms
upto 14 days
Severity of symptoms
Time Frame: upto 14 days
time needed of symptom serverity
upto 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Severity of symptoms
Time Frame: 14 days
time needed to make patients clinically better
14 days
Morality
Time Frame: 30 days
death rate
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sohaib Ashraf

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Muhammad Ashraf, PhD, University of Veterinary & Animal Sciences, Lahore, Pakistan
  • Study Director: Shoaib Ashraf, PhD, Harvard University Boston, USA
  • Principal Investigator: Sohaib Ashraf, MBBS, Shaikh Zayed Medical Complex, Pakistan
  • Principal Investigator: Moneeb Ashraf, MBBS, Mayo Hospital, Pakistan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 14, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SZMC/IRB/Internal/215/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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