NCT04753619

Brief Summary

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

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
150

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Jan 2021

Typical duration for phase_2 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

Study Start

First participant enrolled

January 3, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 10, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2021

Completed
Last Updated

June 22, 2021

Status Verified

June 1, 2021

Enrollment Period

11 months

First QC Date

February 10, 2021

Last Update Submit

June 19, 2021

Conditions

Covid-19SARS Pneumonia

Keywords

NiclosamideCovid-19

Outcome Measures

Primary Outcomes (2)

  • Percentage of Cure of the patient

    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

    \- to study the time to recovery ( stay days in hospital)

    7 days

Secondary Outcomes (3)

  • The percentage of Progressive patients

    7 days

  • Rate of mortality

    7 days

  • Side effects

    7 days

Study Arms (2)

Niclosamide group: NCS group

EXPERIMENTAL

NCL + standard therapy

Drug: Niclosamide Oral Tablet

Control group

NO INTERVENTION

Control group

Interventions

Niclosamide Oral TabletDRUG

* 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.

Also known as: Yomesan
Niclosamide group: NCS group

Eligibility Criteria

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

You may qualify if:

  • Patients with age above 18 years and of any gender.
  • Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18).
  • 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.
  • Understands and agrees to comply with planned study procedures.

You may not qualify if:

  • Patients refuse to enrol in the study
  • Patients with hypersensitivity or severe adverse effects to niclosamide
  • Renal impairment
  • Hepatic impairment
  • Pregnancy or a desire to become pregnant
  • Breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed S. Abdulamir

Baghdad, Baghdada, 00964, Iraq

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Niclosamide

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SalicylanilidesAnilidesAmidesOrganic ChemicalsSalicylamidesAniline CompoundsAmines

Study Officials

  • Ahmed S Abdulamir, Professor

    College of Medicine-Al-Nahrain University

    PRINCIPAL INVESTIGATOR

  • Faiq I. Gorial, Prof

    College of Medicine-University of Baghdad

    PRINCIPAL INVESTIGATOR

  • Manal K abdulrrazaq, Professor

    College of Medicine-University of Baghdad

    STUDY CHAIR

Central Study Contacts

Faiq I. Gorial, Professor

CONTACT

009647801730696faiqig@yahoo.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 10, 2021

First Posted

February 15, 2021

Study Start

January 3, 2021

Primary Completion

December 3, 2021

Study Completion

December 3, 2021

Last Updated

June 22, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

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

Time Frame
6 months after publication
Access Criteria
Will be given by the principle investgator

Locations

IR(1)