Clincosm LogoSign in Get a demo

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

Sponsor
University of Baghdad (Other)
Overall Status
Recruiting
CT.gov ID
NCT04753619
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
11
Anticipated Duration (Months)
13.7
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Niclosamide Oral Tablet
 Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)
Actual Study Start Date :
Jan 3, 2021
Anticipated Primary Completion Date :
Dec 3, 2021
Anticipated Study Completion Date :
Dec 3, 2021

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    No Intervention: Control group

    Control group

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Cure of the patient [7 days]

      To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging.

    2. Time to recovery [7 days]

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

    Secondary Outcome Measures

    1. The percentage of Progressive patients [7 days]

      - T assess percentage of progressive patients to more advanced disease

    2. Rate of mortality [7 days]

      - To evaluate mortality rate among NCS add on group compared to controls

    3. Side effects [7 days]

      - To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed S. Abdulamir Baghdad Baghdada Iraq 00964

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Faiq Gorial, Professor, University of Baghdad
    ClinicalTrials.gov Identifier:
    NCT04753619
    Other Study ID Numbers:
    • PRO2021070003
    First Posted:
    Feb 15, 2021
    Last Update Posted:
    Jun 22, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Faiq Gorial, Professor, University of Baghdad
    Niclosamide
    Covid-19
    Additional relevant MeSH terms:
    COVID-19
    Niclosamide

    Study Results

    No Results Posted as of Jun 22, 2021