Clinical trial NCT04753619: Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management
Official title: Effectiveness of Niclosamide as Add-on Therapy to the Standard of Care Measures in COVID-19 Management (Randomized Controlled Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Covid-19
SARS Pneumonia
Keywords: Niclosamide
Covid-19
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2021-02-15
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Cure of the patient
timeFrame: 7 days
measure: Time to recovery
timeFrame: 7 days
Secondary outcomes:
measure: The percentage of Progressive patients
timeFrame: 7 days
measure: Rate of mortality
timeFrame: 7 days
measure: Side effects
timeFrame: 7 days
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Ahmed S. Abdulamir
state: Baghdada
Study officials:
affiliation: College of Medicine-Al-Nahrain University
name: Ahmed S Abdulamir, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Medicine-University of Baghdad
name: Faiq I. Gorial, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: College of Medicine-University of Baghdad
name: Manal K abdulrrazaq, Professor
role: STUDY_CHAIR
References: