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

NCT04558021 | Unknown Phase 3 DMC

• 1 other identifier: NOV2020/01930
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 8

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.

Conditions

Covid19

Keywords

Coronavirus; Niclosamide Suspension; Anti-viral

Outcome Measures

Primary Outcomes (1)

• Physician's judgment on clinical recovery from the time of admission

  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.)

  Day 1 to day 19

Secondary Outcomes (5)

• Clinical improvement in NEWS2

  3 days from admission

• Improvement in serum biomarkers

  Day 1 to day 3

• Requirement for indotracheal intubation

  Day 1 to day 19

• Occurrence of Macrophage Activation Syndrome(MAS)

  Day 1 to day 19

• Occurrence of Coagulopathy

  Day 1 to day 19

Other Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Day 1 to day 19

Study Arms (2)

Intervention Arm-I

EXPERIMENTAL

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

Intervention Arm-II

PLACEBO COMPARATOR

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

Interventions

Niclosamide suspension DRUG

200mg/10ml

Also known as: Niclonex

Intervention Arm-I

Placebo OTHER

10ml placebo(absent of niclosamide)

Intervention Arm-II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being able to understand the study and to give a written informed consent
• 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:
• 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
• 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
• 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.
• 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
• Patients detected with SARS-COV-2 by molecular methods who meet the criteria for possible case of SARS-COV-2

You may not qualify if:

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

Sponsors & Collaborators

• Imuneks Farma ilac San. Tic. A.S.: lead

Study Sites (8)

Akdeniz Üniversitesi Tıp Fakültesi Hastanesi

Antalya, 07070, Turkey (Türkiye)

RECRUITING

Antalya Eğitim ve Araştırma Hastanesi

Antalya, 07100, Turkey (Türkiye)

RECRUITING

Gaziantep Üniversitesi Tıp Fakültesi Hastanesi

Gaziantep, 27410, Turkey (Türkiye)

RECRUITING

Gaziosmanpaşa Taksim Eğitim ve Araştırma Hastanesi

Istanbul, 34255, Turkey (Türkiye)

RECRUITING

Dokuz Eylül Üniversitesi Hastanesi

Izmir, 1606, Turkey (Türkiye)

RECRUITING

İzmir SBÜ Tepecik Eğitim ve Araştırma Hastanesi

Izmir, 35020, Turkey (Türkiye)

RECRUITING

SBÜ Dr. Suat Seren Göğüs Hastalıkları ve Cerrahisi Eğitim ve Araştırma Hastanesi

Izmir, 35110, Turkey (Türkiye)

RECRUITING

İzmir Katip Çelebi Üniversitesi Atatürk Eğitim ve Araştırma Hastanesi

Izmir, 35150, Turkey (Türkiye)

RECRUITING

Related Publications (1)

• Wu CJ, Jan JT, Chen CM, Hsieh HP, Hwang DR, Liu HW, Liu CY, Huang HW, Chen SC, Hong CF, Lin RK, Chao YS, Hsu JT. Inhibition of severe acute respiratory syndrome coronavirus replication by niclosamide. Antimicrob Agents Chemother. 2004 Jul;48(7):2693-6. doi: 10.1128/AAC.48.7.2693-2696.2004.

  PMID: 15215127 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Aydin Erenmemisoglu, Prof.Dr.

  ALPAN Farma Ltd.Sti.

  STUDY DIRECTOR

Central Study Contacts

Aydin Erenmemisoglu, Prof.Dr.

CONTACT

+90 352 224-2322; erenmemis@gmail.com

Ayşe Ö Mete, Dr.

CONTACT

+90 506 488-3309; ayseozlem_ornek@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 22, 2020
• Study Start: October 8, 2020
• Primary Completion: January 30, 2021
• Study Completion: February 14, 2021
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (8)