Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

NCT04348409 | Completed DMC

• 1 other identifier: NITFQM0320OR
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (1)

• Viral load

  PCR will be done to evaluate the change in viral load

  day 1, 4, 7, 14 and 21

Secondary Outcomes (5)

• Evolution of acute respiratory syndrome

  21 days

• Change in Clinical Condition

  21 days

• Hospital discharge

  21 days

• Rate of mortality within 21-days

  21 days

• Need of mechanical ventilation

  21 days

Study Arms (2)

nitazoxanide

EXPERIMENTAL

Patients will receive nitazoxanide 600 mg BID for 7 days.

Drug: Nitazoxanide Tablets

Placebo

PLACEBO COMPARATOR

Patients will receive placebo BID for 7 days

Drug: Placebo

Interventions

Nitazoxanide Tablets DRUG

Patients will receive nitazoxanide 600 mg BID for 7 days

nitazoxanide

Placebo DRUG

Patients will receive placebo BID for 7 days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent from patient or legal representative.
• Male or female, aged ≥ 18 years;
• Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
• Signs of respiratory failure requiring oxygen therapy
• Hospitalized for up to 36h with non-invasive ventilation
• Negative result for pregnancy test (if applicable).

You may not qualify if:

• Participating in another RCT in the past 12 months;
• Known allergy to nitazoxanide
• Severely reduced LV function;
• Severely reduced renal function;
• Pregnancy or breast feeding;
• Use of hydroxychloroquine and/or azithromycin in the past 15 days;
• Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products

Sponsors & Collaborators

• Azidus Brasil: lead
• Farmoquimica S.A.: collaborator
• Hospital Vera Cruz: collaborator
• Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil: collaborator
• Centro de Genomas - UNIFESP: collaborator
• Emilio Ribas Institute of Infectious Diseases: collaborator

Study Sites (3)

Hospital Vera Cruz

Campinas, São Paulo, Brazil

Location

Centro de Genomas

São Paulo, Brazil

Location

Hospital Emílio Ribas

São Paulo, Brazil

Location

Related Publications (1)

• Blum VF, Cimerman S, Hunter JR, Tierno P, Lacerda A, Soeiro A, Cardoso F, Bellei NC, Maricato J, Mantovani N, Vassao M, Dias D, Galinskas J, Janini LMR, Santos-Oliveira JR, Da-Cruz AM, Diaz RS. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine. 2021 Jul;37:100981. doi: 10.1016/j.eclinm.2021.100981. Epub 2021 Jun 27.

  PMID: 34222847 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to receive either nitazoxanide or placebo (1:1).

Study Record Dates

• First Submitted: April 3, 2020
• First Posted: April 16, 2020
• Study Start: May 25, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 28, 2022

Record last verified: 2022-10

Locations

BR (3)