Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management

June 19, 2021 updated by: Faiq Gorial, University of Baghdad

Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)

Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Protocol of therapy Niclosamaide Add on group

  • NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days]
  • If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.

Control group The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient:

  • Acetaminophen 500mg on need
  • Vitamin C 1000mg twice/ day
  • Zinc 75-125 mg/day
  • Vitamin D3 5000IU/day
  • Azithromycin 250mg/day for 5 days
  • Oxygen therapy/ C-Pap if needed
  • Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
  • Mechanical ventilation, if needed

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 2

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

  • Name: Faiq I. Gorial, Professor
  • Phone Number: 009647801730696
  • Email: faiqig@yahoo.com

Study Locations

  • Iraq
    • Baghdada
      • Baghdad, Baghdada, Iraq, 00964
        • Recruiting
        • Ahmed S. Abdulamir
        • Contact:
          • Faiq I. Gorial, Professor
          • Phone Number: 009647801730696
          • Email: faiqig@yahoo.com
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with age above 18 years and of any gender.
  2. Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18).
  3. Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases.
  4. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

  1. Patients refuse to enrol in the study
  2. Patients with hypersensitivity or severe adverse effects to niclosamide
  3. Renal impairment
  4. Hepatic impairment
  5. Pregnancy or a desire to become pregnant
  6. Breast feeding

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: Niclosamide group: NCS group
NCL + standard therapy
Drug: Niclosamide Oral Tablet
  • NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days]
  • If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.
Other Names:
  • Yomesan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Cure of the patient
Time Frame: 7 days
To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging.
7 days
Time to recovery
Time Frame: 7 days
- to study the time to recovery ( stay days in hospital)
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The percentage of Progressive patients
Time Frame: 7 days
- T assess percentage of progressive patients to more advanced disease
7 days
Rate of mortality
Time Frame: 7 days
- To evaluate mortality rate among NCS add on group compared to controls
7 days
Side effects
Time Frame: 7 days
- To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation.
7 days

Collaborators and Investigators

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

Sponsor

University of Baghdad

Investigators

  • Principal Investigator: Ahmed S Abdulamir, Professor, College of Medicine-Al-Nahrain University
  • Principal Investigator: Faiq I. Gorial, Prof, College of Medicine-University of Baghdad
  • Study Chair: Manal K abdulrrazaq, Professor, College of Medicine-University of Baghdad

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)

January 3, 2021

Primary Completion (Anticipated)

December 3, 2021

Study Completion (Anticipated)

December 3, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

February 11, 2021

First Posted (Actual)

February 15, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 19, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO2021070003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

All collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

6 months after publication

IPD Sharing Access Criteria

Will be given by the principle investgator

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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