Clinical trial: A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19 (NCT04558021)

Eligibility 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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): The patient is a 38-year-old man with cough and body ache that started 3 days ago.  He had fever and chills at the beginning and has low grade fever at the time of visit. He feels tired and sleepy. His body ache and myalgia get better after using Tylenol. The PCR test for Covid is positive. His vital signs are within normal limits with a body temperature of 37.9 C. There is no lymphadenopathy or white exudates in the pharynx.

Patient description (patient's own words): I was feeling really sick the other day, to the point that I showed up at the doctor's office. I was coughing, and my body was hurting for 3 days. I had a fever and chills and felt tired and sleepy. I got better after using Tylenol. They did a PCR Covid test on me, and it was positive! My vitals were normal, and my temperature was 37.9 C. I had no swelling around my neck or white spots on the back of my throat.

Does the patient match the trial criteria? 1