Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)
Overview
- Phase
- Phase 2
- Intervention
- Niclosamide Oral Tablet
- Conditions
- Covid-19
- Sponsor
- University of Baghdad
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Time to recovery
- Last Updated
- 4 years ago
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
Investigators
Faiq Gorial
Professor
University of Baghdad
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
Arms & Interventions
Niclosamide group: NCS group
NCL + standard therapy
Intervention: Niclosamide Oral Tablet
Outcomes
Primary Outcomes
Time to recovery
Time Frame: 7 days
- to study the time to recovery ( stay days in hospital)
Percentage of Cure of the patient
Time Frame: 7 days
To assess the percentage of cure of the patient and evaluated by normalization of clinical evaluation, laboratory investigations, and imaging.
Secondary Outcomes
- The percentage of Progressive patients(7 days)
- Rate of mortality(7 days)
- Side effects(7 days)