Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19

NCT04423861 | Unknown Phase 3 DMC

• 1 other identifier: NITFQM0920OR-III
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

Conditions

covid19

Outcome Measures

Primary Outcomes (1)

• Need of mechanical ventilation

  Evaluation of change in acute respiratory syndrome using WHO Ordinal Scale for Clinical Improvement that measures illness severity over time (0=uninfected; ambulatory, no limitation of activities=1; ambulatory, limitation of activities=2, hospitalized no oxygen therapy=3; hospitalized oxygen by mask or nasal prongs=4; hospitalized non invasive ventilation or high-flow oxygen=5; hospitalized intubation or mechanical ventilation=6; hospitalized ventilation + additional organ support=7; death=8)

  14 days

Secondary Outcomes (5)

• Change in the pulmonary condition

  Baseline, Day 7 and Day 14

• Change in Clinical Condition

  Baseline, Day 7 and Day 14

• Change in tomographic pulmonary condition

  Baseline, Day 7

• Rate of mortality within 14-days

  14 days

• Change in inflammatory markers

  Baseine, Day 7, Day 14

Study Arms (2)

nitazoxanide BID

EXPERIMENTAL

Patients will receive nitazoxanide 600 mg BID for 7 days.

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Patients will receive matching placebo BID for 7 days.

Drug: Placebo

Interventions

Nitazoxanide DRUG

Patients will receive nitazoxanide 600 mg BID for 7 days.

Also known as: Viranitta (Nitazoxanide)

nitazoxanide BID

Placebo DRUG

Patients will receive matching 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;
• Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation \<98%;
• \. 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;
• Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
• History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
• Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
• Diagnose of severe autoimmune diseases in immunosuppression;
• Transplanted patients;
• 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

Study Sites (1)

Hospital Vera Cruz

Campinas, São Paulo, Brazil

RECRUITING

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 Officials

• Florentino de Araujo Cardoso Filho, MD, PhD

  +55 19 991232882

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Florentino de Araujo Cardoso Filho, MD, PhD

CONTACT

+55 19 991232882; florentino.cardoso@hospitalcare.com.br

Luciana Ferrara

CONTACT

+55 19 981428814; luciana.ferrara@azidusbrasil.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• 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 600 mg BID or Placebo (1:1)

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 9, 2020
• Study Start: June 22, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

BR (1)