Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management
Primary Purpose
Covid-19, SARS Pneumonia
Status
Unknown status
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Niclosamide Oral Tablet
Sponsored by
About this trial
This is an interventional treatment trial for Covid-19 focused on measuring Niclosamide, Covid-19
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Ahmed S. AbdulamirRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Niclosamide group: NCS group
Control group
Arm Description
NCL + standard therapy
Control group
Outcomes
Primary Outcome Measures
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.
Time to recovery
- to study the time to recovery ( stay days in hospital)
Secondary Outcome Measures
The percentage of Progressive patients
- T assess percentage of progressive patients to more advanced disease
Rate of mortality
- To evaluate mortality rate among NCS add on group compared to controls
Side effects
- To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04753619
Brief Title
Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management
Official Title
Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 3, 2021 (Actual)
Primary Completion Date
December 3, 2021 (Anticipated)
Study Completion Date
December 3, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid-19, SARS Pneumonia
Keywords
Niclosamide, Covid-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Niclosamide group: NCS group
Arm Type
Experimental
Arm Description
NCL + standard therapy
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group
Intervention Type
Drug
Intervention Name(s)
Niclosamide Oral Tablet
Other Intervention Name(s)
Yomesan
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Cure of the patient
Description
To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging.
Time Frame
7 days
Title
Time to recovery
Description
- to study the time to recovery ( stay days in hospital)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
The percentage of Progressive patients
Description
- T assess percentage of progressive patients to more advanced disease
Time Frame
7 days
Title
Rate of mortality
Description
- To evaluate mortality rate among NCS add on group compared to controls
Time Frame
7 days
Title
Side effects
Description
- To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faiq I. Gorial, Professor
Phone
009647801730696
Email
faiqig@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Abdulamir, Professor
Organizational Affiliation
College of Medicine-Al-Nahrain University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Faiq I. Gorial, Prof
Organizational Affiliation
College of Medicine-University of Baghdad
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Manal K abdulrrazaq, Professor
Organizational Affiliation
College of Medicine-University of Baghdad
Official's Role
Study Chair
Facility Information:
Facility Name
Ahmed S. Abdulamir
City
Baghdad
State/Province
Baghdada
ZIP/Postal Code
00964
Country
Iraq
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ahmed S. Abdulamir, Professor
Phone
009747702677741
Email
ahmsah73@yahoo.com
First Name & Middle Initial & Last Name & Degree
Faiq I. Gorial, Professor
Phone
009647801730696
Email
faiqig@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Learn more about this trial
Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management
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