NCT04463264

Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)

Status unknown Phase 2, PHASE3 Last updated 8 October 2020

What this trial tests

Phase 2, PHASE3 trial testing Nitazoxanide in COVID-19 in 135 participants. Status unknown.

Timeline

26 June 2020

Primary endpoint
15 November 2020

26 December 2020

Quick facts

Lead sponsor	Laboratorios Roemmers S.A.I.C.F.
Phase	Phase 2, PHASE3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	135
Start date	26 June 2020
Primary completion	15 November 2020
Estimated completion	26 December 2020
Sites	1 location across Argentina

Drugs / interventions tested

• Nitazoxanide (NITAZOXANIDE) — full drug profile →
• Placebo

Conditions studied

• COVID-19 — all drugs for COVID-19 →

Sponsor

Laboratorios Roemmers S.A.I.C.F.

Who can join

Adults 18 to 59, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and \<60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients will be randomized to either Nitazoxanide (n=90) or placebo (n=45) (2:1). Simple blind design. Primary endpoint: eradication of virus from patients' respiratory tract secretions by the 7th day of treatment.

Publications & conference data

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

1. Molecular mechanism of interaction between SARS-CoV-2 and host cells and interventional therapy.
   Zhang Q, Xiang R, Huo S, Zhou Y, et al · · 2021 · cited 219× · PMID 34117216 · DOI 10.1038/s41392-021-00653-w
2. 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
3. A review of potential suggested drugs for coronavirus disease (COVID-19) treatment.
   Tarighi P, Eftekhari S, Chizari M, Sabernavaei M, et al · · 2021 · cited 80× · PMID 33482181 · DOI 10.1016/j.ejphar.2021.173890
4. A review on possible mechanistic insights of Nitazoxanide for repurposing in COVID-19.
   Lokhande AS, Devarajan PV. · · 2021 · cited 69× · PMID 33227285 · DOI 10.1016/j.ejphar.2020.173748
5. 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
6. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial.
   Blum VF, Cimerman S, Hunter JR, Tierno P, et al · · 2021 · cited 50× · PMID 34222847 · DOI 10.1016/j.eclinm.2021.100981
7. Anti-viral treatment for SARS-CoV-2 infection: A race against time amidst the ongoing pandemic.
   Vallianou NG, Tsilingiris D, Christodoulatos GS, Karampela I, et al · · 2021 · cited 28× · PMID 34056571 · DOI 10.1016/j.metop.2021.100096
8. Adjunctive Nutraceutical Therapies for COVID-19.
   Subedi L, Tchen S, Gaire BP, Hu B, et al · · 2021 · cited 28× · PMID 33669456 · DOI 10.3390/ijms22041963