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

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

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

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

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

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.

To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging.

- To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation.

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