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

Phase 2

• Conditions: Covid-19; SARS Pneumonia
• Interventions: Drug: Niclosamide Oral Tablet

• Registration Number: NCT04753619
• Lead Sponsor: University of Baghdad

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

Study Timeline

• Study Start: 2021-01-03
• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-11
• Study First Posted: 2021-02-15
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-19
• Last Update Posted: 2021-06-22
• Primary Completion: 2021-12-03
• Study Completion: 2021-12-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Niclosamide group: NCS group	Niclosamide Oral Tablet	NCL + standard therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Ahmed S. Abdulamir; 🇮🇶 Baghdad, Baghdada, Iraq