Covid19 Clinical Trial
— NICLONEXOfficial 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)
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.
Status | Recruiting |
Enrollment | 200 |
Est. completion date | February 14, 2021 |
Est. primary completion date | January 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz Üniversitesi Tip Fakültesi Hastanesi | Antalya | |
Turkey | Antalya Egitim ve Arastirma Hastanesi | Antalya | |
Turkey | Gaziantep Üniversitesi Tip Fakültesi Hastanesi | Gaziantep | |
Turkey | Gaziosmanpasa Taksim Egitim ve Arastirma Hastanesi | Istanbul | |
Turkey | Dokuz Eylül Üniversitesi Hastanesi | Izmir | |
Turkey | Izmir Katip Çelebi Üniversitesi Atatürk Egitim ve Arastirma Hastanesi | Izmir | |
Turkey | Izmir SBÜ Tepecik Egitim ve Arastirma Hastanesi | Izmir | |
Turkey | SBÜ Dr. Suat Seren Gögüs Hastaliklari ve Cerrahisi Egitim ve Arastirma Hastanesi | Izmir |
Lead Sponsor | Collaborator |
---|---|
Imuneks Farma ilac San. Tic. A.S. |
Turkey,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | The assessment of safety will be based on CTCAE v4.0 | Day 1 to day 19 | |
Primary | 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 | Clinical improvement in NEWS2 | (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) | 3 days from admission | |
Secondary | Improvement in serum biomarkers | 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. | Day 1 to day 3 | |
Secondary | Requirement for indotracheal intubation | Requirement for indotracheal intubation is a key outcome for unsuccesful treatment | Day 1 to day 19 | |
Secondary | Occurrence of Macrophage Activation Syndrome(MAS) | Occurrence of Macrophage Activation Syndrome(MAS) will alert the physician that the patients condition is worsening. | Day 1 to day 19 | |
Secondary | Occurrence of Coagulopathy | Occurrence of Coagulopathy will alert the physician that the patients condition is worsening. | Day 1 to day 19 |
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