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

Covid-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04753619
• Other study ID #: PRO2021070003
• Status: Recruiting
• Phase: Phase 2
• Start date: January 3, 2021
• Est. completion date: December 3, 2021

Study information

• Verified date: June 2021
• Source: University of Baghdad
• Contact: Faiq I. Gorial, Professor
• Phone: 009647801730696
• Email: faiqig[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 3, 2021
• Est. primary completion date: December 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients with age above 18 years and of any gender.

2. Definite diagnosis of COVID-19 according to the WHO classification criteria ( 18).

3. 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.

4. Understands and agrees to comply with planned study procedures.

Exclusion Criteria:

1. Patients refuse to enrol in the study

2. Patients with hypersensitivity or severe adverse effects to niclosamide

3. Renal impairment

4. Hepatic impairment

5. Pregnancy or a desire to become pregnant

6. Breast feeding

Related Conditions & MeSH terms

• Covid-19
• Pneumonia
• SARS Pneumonia

Intervention

Drug:
• Niclosamide Oral Tablet
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.

Locations

Country	Name	City	State
Iraq	Ahmed S. Abdulamir	Baghdad	Baghdada

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Time to recovery	- to study the time to recovery ( stay days in hospital)	7 days
Secondary	The percentage of Progressive patients	- T assess percentage of progressive patients to more advanced disease	7 days
Secondary	Rate of mortality	- To evaluate mortality rate among NCS add on group compared to controls	7 days
Secondary	Side effects	- To demonstrate side effects seen during the trial and will be assessed according clinical evaluation and the appropriate laboratory investigation.	7 days