Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management

Study Overview
=================
Brief Summary
-----------------
Assessment of the Effectiveness of Niclosamide as Add on Therapy to the Standard of care Measures in COVID-19 Management in a randomized controlled clinical trial

Detailed Description
-----------------
Protocol of therapy Niclosamaide Add on group NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days] If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding. Control group The patients in this group will receive only standard care which will include all or some of the following, according to the clinical condition of each patient: Acetaminophen 500mg on need Vitamin C 1000mg twice/ day Zinc 75-125 mg/day Vitamin D3 5000IU/day Azithromycin 250mg/day for 5 days Oxygen therapy/ C-Pap if needed Dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed Mechanical ventilation, if needed

Official Title
-----------------
Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)

Conditions
-----------------
Covid-19, SARS Pneumonia

Intervention / Treatment
-----------------
* Drug: Niclosamide Oral Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with age above 18 years and of any gender. Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18). Patients symptomatic for no more than three days for mild-moderate cases, no more than two days after being severe cases, and no more than one day after being critical cases. Understands and agrees to comply with planned study procedures. Exclusion Criteria: Patients refuse to enrol in the study Patients with hypersensitivity or severe adverse effects to niclosamide Renal impairment Hepatic impairment Pregnancy or a desire to become pregnant Breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Niclosamide group: NCS group<br>NCL + standard therapy | Drug: Niclosamide Oral Tablet<br>* NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days] If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding.<br>* Other names: Yomesan;|
| No Intervention: Control group<br>Control group | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Cure of the patient | To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging. | 7 days | 
| Time to recovery | - to study the time to recovery ( stay days in hospital) | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of Progressive patients | - T assess percentage of progressive patients to more advanced disease | 7 days | 
| Rate of mortality | - To evaluate mortality rate among NCS add on group compared to controls | 7 days | 
| Side effects | - To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation. | 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Niclosamide, Covid-19