Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19 (NICLONEX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04558021
Recruitment Status : Recruiting
First Posted : September 22, 2020
Last Update Posted : October 12, 2020
Sponsor:
Information provided by (Responsible Party):
Imuneks Farma ilac San. Tic. A.S.

Brief Summary:

This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients.

The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo.

The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.


Condition or disease Intervention/treatment Phase
Covid19 Drug: Niclosamide suspension Other: Placebo Phase 3

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 200 patients will receive either 200 mg niclosamide in 10 mL of suspension or 10 mL of placebo three times a day together with an established treatment regimen in 1:1 ratio. The study will be conducted in 2 parts: an interim analysis will be conducted after the first 100 patients.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III, Randomized, Placebo-controlled, Clinical Trial to Evaluate the Efficacy and Safety of Co-administered Niclosamide in Patients Treated With an Established Regimen for Novel Coronavirus Infectious Disease (COVID-19)
Actual Study Start Date : October 8, 2020
Estimated Primary Completion Date : January 30, 2021
Estimated Study Completion Date : February 14, 2021

Arm Intervention/treatment
Experimental: Intervention Arm-I
Niclosamide 200 mg/10 mL Suspension will be administered to patients 3 times a day for 5 days along with the treatment regimen selected according to the official guidance for COVID-19 Adult Treatment Algorithm established by Republic of Turkey Ministry of Health
Drug: Niclosamide suspension
200mg/10ml
Other Name: Niclonex

Placebo Comparator: Intervention Arm-II
10 mL placebo will be administered to patients 3 times a day for 5 days along with the treatment regimen selected according to the official guidance for COVID-19 Adult Treatment Algorithm established by Republic of Turkey Ministry of Health
Other: Placebo
10ml placebo(absent of niclosamide)




Primary Outcome Measures :
  1. Physician's judgment on clinical recovery from the time of admission [ Time Frame: Day 1 to day 19 ]

    The physician will check for the following symptoms:

    • Fever: axillary temperature ≤36.6°C or oral temperature ≤37.2 °C;
    • Respiratory rate: ≤24/minute on room air;
    • Oxygen saturation: >94% on room air;
    • Cough: mild or absent on a patient reported scale of severe, moderate, mild, absent.)


Secondary Outcome Measures :
  1. Clinical improvement in NEWS2 [ Time Frame: 3 days from admission ]
    (National Early Warning Score 2) to 0 to 3 (Improvement in fever, respiratory rate, oxygen saturation,alleviation of cough scores to 3 points to 0 in 72 hours)

  2. Improvement in serum biomarkers [ Time Frame: Day 1 to day 3 ]
    An elevated D-dimer,ferritin, thrombocyte, PT, aPTT, troponine and fibrinogen were associated with a poor outcome in COVID19. These parameters will be checked on day 1 and day 3.

  3. Requirement for indotracheal intubation [ Time Frame: Day 1 to day 19 ]
    Requirement for indotracheal intubation is a key outcome for unsuccesful treatment

  4. Occurrence of Macrophage Activation Syndrome(MAS) [ Time Frame: Day 1 to day 19 ]
    Occurrence of Macrophage Activation Syndrome(MAS) will alert the physician that the patients condition is worsening.

  5. Occurrence of Coagulopathy [ Time Frame: Day 1 to day 19 ]
    Occurrence of Coagulopathy will alert the physician that the patients condition is worsening.


Other Outcome Measures:
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: Day 1 to day 19 ]
    The assessment of safety will be based on CTCAE v4.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Being able to understand the study and to give a written informed consent
  2. Adult hospitalized patients (aged ≥18) confirmed or suspected for COVID-19 according to the official General Information, Epidemiology and Diagnosis Guidance for COVID-19 (SARS-CoV-2 Infection) published by Republic of Turkey Ministry of Health showing at least one of the symptoms below:

    1. fever, cough, difficulty in breathing, sore throat, headache, muscle or body aches, new loss of taste or smell, diarreha without explanation of any cause than COVID-19 and history of herself/himself or her/his close contact presenting in the high-risk area of the disease within 14 days prior to the onset of symptoms or
    2. at least one of the symptoms of fever, cough, difficulty in breathing, sore throat, headache, muscle or body aches, new loss of taste or smell, diarrhea without explanation of any cause than COVID-19 and close contact with confirmed COVID-19 case within 14 days prior to symptoms or
    3. fever and at least one of the signs and symptoms of the severe acute respiratory infection (cough and difficulty in breathing) and need for hospitalization due to severe acute respiratory infection (SARI) explanation failure of the clinical features other than COVID-19 SARI: The need for hospitalization in a patient with acute respiratory infection due to fever, cough and dyspnea, tachypnea, hypoxemia, hypotension, wide radiological findings and consciousness developing in the last 14 days.

      or

    4. at least two of the signs and symptoms of fever, cough, difficulty in breathing, sore throat, headache, muscle or body aches, new loss of taste or smell, diarrhoea without explanation of any cause than COVID-19 or
  3. Patients detected with SARS-COV-2 by molecular methods who meet the criteria for possible case of SARS-COV-2

Exclusion Criteria:

  1. Who have allergy to niclosamide and/or any of the treatment agents and/or any of the excipients of the products,
  2. Who is diagnosed as "severe or critical case" (e.g. pneumonia or severe pneumonia),
  3. Whose National Early Warning Score 2 (NEWS2) score is indicated as "urgent" or "emergency",
  4. Any history of bone marrow transplant, solid-organ transplant, immune compromising conditions, immunomodulatory therapy, haematologic malignancy,
  5. Who have Multiple Sclerosis,
  6. Who have electrolyte imbalance, chronic haemodialysis or glomerular filtration rate < 30 30 mL/min/1.73m2,
  7. Who have history of serious cardiovascular diseases,
  8. Who are diagnosed with another ongoing viral infection other than SARS CoV-2,
  9. Who have macrophage activation syndrome,
  10. Who have a need for coagulopathy treatment,
  11. Who have severe liver disease,
  12. Who is pregnant or nursing,
  13. Who are not suitable to 1st articles of inclusion criteria,
  14. Who is not eligible to swallow oral medications,
  15. Who use vitamin C as supplementary medication during the study,
  16. Who are included in another trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04558021


Contacts
Layout table for location contacts
Contact: Aydin Erenmemisoglu, Prof.Dr. +90 352 224-2322 erenmemis@gmail.com
Contact: Ayşe Ö Mete, Dr. +90 506 488-3309 ayseozlem_ornek@hotmail.com

Locations
Layout table for location information
Turkey
Akdeniz Üniversitesi Tıp Fakültesi Hastanesi Recruiting
Antalya, Turkey, 07070
Antalya Eğitim ve Araştırma Hastanesi Recruiting
Antalya, Turkey, 07100
Gaziantep Üniversitesi Tıp Fakültesi Hastanesi Recruiting
Gaziantep, Turkey, 27410
Contact: Ayse O Mete, Dr.    +90342 360 60 60    ayseozlem_ornek@hotmail.com   
Contact: İlkay Karaoglan, Prof. Dr.    +90342 360 60 60    ikaraoglan10@hotmail.com   
Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi Recruiting
Istanbul, Turkey, 34255
Dokuz Eylül Üniversitesi Hastanesi Recruiting
İzmir, Turkey, 1606
İzmir SBÜ Tepecik Eğitim ve Araştırma Hastanesi Recruiting
İzmir, Turkey, 35020
SBÜ Dr. Suat Seren Göğüs Hastalıkları ve Cerrahisi Eğitim ve Araştırma Hastanesi Recruiting
İzmir, Turkey, 35110
İzmir Katip Çelebi Üniversitesi Atatürk Eğitim ve Araştırma Hastanesi Recruiting
İzmir, Turkey, 35150
Sponsors and Collaborators
Imuneks Farma ilac San. Tic. A.S.
Investigators
Layout table for investigator information
Study Director: Aydin Erenmemisoglu, Prof.Dr. ALPAN Farma Ltd.Sti.
Publications:
Layout table for additonal information
Responsible Party: Imuneks Farma ilac San. Tic. A.S.
ClinicalTrials.gov Identifier: NCT04558021    
Other Study ID Numbers: NOV2020/01930
First Posted: September 22, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Imuneks Farma ilac San. Tic. A.S.:
Coronavirus
Niclosamide Suspension
Anti-viral
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Niclosamide
Anticestodal Agents
Antiplatyhelmintic Agents
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents