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

• Status: Recruiting
• Trial end date: 2021-02-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imuneks Farma ilac San. Tic. A.S.
• Treatments: Niclosamide

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.