COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04558021

Aydin Erenmemisoglu, Prof.Dr.

erenmemis@gmail.com

2020-09-22

Unknown

RCT

Randomized

Parallel

Blind label

multi-center

Treatment

inclusion criteria: 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. or 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

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 are not suitable to 1st articles of inclusion criteria, who is not eligible to swallow oral medications, who use vitamin c as supplementary medication during the study, who are included in another trial.

2

Imuneks Farma ilac San. Tic. A.S.

18

100

Turkey

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

200

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

None

Phase 3

[{"arm_notes": "", "treatment_id": 883, "treatment_name": "Niclosamide", "treatment_type": "Antiparasitics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]