NCT04558021: NICLONEX

A Study To Evaluate The Efficacy And Safety Of a Novel Niclosamide Suspension Formulation For COVID-19

Status unknown Phase 3 Last updated 12 October 2020

What this trial tests

Phase 3 trial testing Niclosamide suspension in Covid19 in 200 participants. Status unknown.

Timeline

8 October 2020

Primary endpoint
30 January 2021

14 February 2021

Quick facts

Lead sponsor	Imuneks Farma ilac San. Tic. A.S.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	200
Start date	8 October 2020
Primary completion	30 January 2021
Estimated completion	14 February 2021
Sites	8 locations across Turkey (Türkiye)

Drugs / interventions tested

• Niclosamide suspension
• Placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Imuneks Farma ilac San. Tic. A.S. — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study aims to investigate the potential antiviral efficacy and safety of a novel formulation of Niclosamide; a well-known antihelmintic agent, together with an established COVID-19 treatment regimen in patients.

The aim of this study is to evaluate the safety and efficacy profile of niclosamide from the test product (Niclosamide 200 mg/10 mL Suspension) in patients treated for the novel coronavirus infectious disease (COVID-19) in a placebo controlled phase III trial. Both treatment groups will receive an established treatment regimen against COVID-19 together with either niclosamide or placebo.

The efficacy and safety of the molecule is well-known and the properties of novel formulation is well-established. The promising in vitro results of niclosamide as an antiviral compound is well documented and make it an ideal candidate as a therapy against SARS-CoV 2 infection. A good safety profile is expected with solid antiviral activity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Small molecules in the treatment of COVID-19.
   Lei S, Chen X, Wu J, Duan X, et al · · 2022 · cited 74× · PMID 36464706 · DOI 10.1038/s41392-022-01249-8
3. Races of small molecule clinical trials for the treatment of COVID-19: An up-to-date comprehensive review.
   Hu S, Jiang S, Qi X, Bai R, et al · · 2022 · cited 68× · PMID 34762760 · DOI 10.1002/ddr.21895
4. Niclosamide-A promising treatment for COVID-19.
   Singh S, Weiss A, Goodman J, Fisk M, et al · · 2022 · cited 64× · PMID 35348204 · DOI 10.1111/bph.15843
5. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
6. Pharmacological Modulation of Ion Channels for the Treatment of Cystic Fibrosis.
   Pinto MC, Silva IAL, Figueira MF, Amaral MD, et al · · 2021 · cited 37× · PMID 34326672 · DOI 10.2147/jep.s255377
7. Transcriptomics-based drug repositioning pipeline identifies therapeutic candidates for COVID-19.
   Le BL, Andreoletti G, Oskotsky T, Vallejo-Gracia A, et al · · 2021 · cited 35× · PMID 34112877 · DOI 10.1038/s41598-021-91625-1
8. Niclosamide-loaded nanoparticles (Ncl-NPs) reverse pulmonary fibrosis in vivo and in vitro.
   Gan C, Wang Y, Xiang Z, Liu H, et al · · 2023 · cited 22× · PMID 36347425 · DOI 10.1016/j.jare.2022.10.018