Effects of Early Use of Nitazoxanide in Patients With COVID-19

NCT04552483 | Completed Phase 2 DMC

• 3 other identifiers: SARITA-2RBR-4nr86m32258920.0.1001.5257
• Study Type: interventional
• Target: 392
• Locations: 1 country
• Sites: 1

Brief Summary

Multicenter, randomized, placebo-controlled, parallel, blinded, interventional, treatment clinical trial with two arms. Population: 392 Patients with COVID-19 (Coronavirus Disease-19), confirmed by RT-PCR (Real Time polymerase chain reaction), symptomatic in the early phase of the disease. Experimental group: 196 patients, nitazoxanide 500mg 8 / 8 hours for 5 days. Control group: 196 patients, placebo 8/8 hours for 5 days.

Conditions

Covid19; Coronavirus

Keywords

covid19; coronavirus; early treatment; COVID-19; new coronavirus; treatment; brazil; nitazoxanide

Outcome Measures

Primary Outcomes (3)

• Days with fever

  Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.

  Day8

• Days with cough

  Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.

  Day8

• Days with asthenia

  Reduction in the duration of asthenia of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.

  Day8

Secondary Outcomes (24)

• SARS-COV-2 viral load - absolute number

  Day1

• SARS-COV-2 viral load - absolute number

  Day8

• SARS-COV-2 viral load - percentage

  Day 1

• SARS-COV-2 viral load - percentage

  Day 8

• Hospital admission rate - absolute number

  Day8

Other Outcomes (4)

• Adverse events - percentage

  Day 8

• Adverse events - absolute number

  Day8

• Treatment discontinuation rate - absolute number

  Day8

Study Arms (2)

Nitazoxanide

EXPERIMENTAL

Patients received nitazoxanide 500mg 8/8hours, for 5 days.

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Patients received placebo 500mg 8/8hours, for 5 days.

Drug: Placebo

Interventions

Nitazoxanide DRUG

Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.

Also known as: azox, annita, irose, tanisea, trinida, zoxany

Nitazoxanide

Placebo DRUG

Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.

Placebo

Eligibility Criteria

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

You may qualify if:

• Clinical scenario compatible with infection by the SARS-CoV-2 \[Characteristic symptoms of COVID-19 (fever and / or cough and / or fatigue)
• Age equal or superior to 18 years
• Willingness to receive study treatment
• Providing written and informed consent or the same consent signed by a family member

You may not qualify if:

• Negative result of RT-PCR for SARS-COV2 collected on admission
• Impossibility to use oral medications
• History of severe liver disease (Child Pugh C class)
• Previous renal failure
• Severe heart failure (NYHA 3 or 4)
• COPD (GOLD 3 and 4)
• Neoplasia in the last 5 years
• Known autoimmune disease
• Individuals with known hypersensitivity to study drug
• Previous treatment with the study medication during the last 30 days
• Clinical suspicion of tuberculosis and bacterial pneumonia

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Ministry of Science and Technology, Brazil: collaborator
• National Research Council, Brazil: collaborator
• ATCGen: collaborator
• Complexo Hospitalar Municipal de São Caetano do Sul: collaborator
• Hospital de Transplante Doutor Euryclides de Jesus Zerbini: collaborator
• Secretaria Municipal de Saúde de Bauru: collaborator
• Santa Casa de Misericórdia de Sorocaba: collaborator
• Secretaria Municipal de Saúde de Guarulhos: collaborator
• Hospital e Maternidade Therezinha de Jesus: collaborator
• Secretaria de Estado de Saúde do Distrito Federal: collaborator

Study Sites (1)

Universidade Federal do Rio de Janeiro

Rio de Janeiro, 21941902, Brazil

Location

Related Publications (4)

• Rossignol JF. Nitazoxanide, a new drug candidate for the treatment of Middle East respiratory syndrome coronavirus. J Infect Public Health. 2016 May-Jun;9(3):227-30. doi: 10.1016/j.jiph.2016.04.001. Epub 2016 Apr 16.

  PMID: 27095301 BACKGROUND

• Rossignol JF. Nitazoxanide: a first-in-class broad-spectrum antiviral agent. Antiviral Res. 2014 Oct;110:94-103. doi: 10.1016/j.antiviral.2014.07.014. Epub 2014 Aug 7.

  PMID: 25108173 BACKGROUND

• Rajoli RK, Pertinez H, Arshad U, Box H, Tatham L, Curley P, Neary M, Sharp J, Liptrott NJ, Valentijn A, David C, Rannard SP, Aljayyoussi G, Pennington SH, Hill A, Boffito M, Ward SA, Khoo SH, Bray PG, O'Neill PM, Hong WD, Biagini G, Owen A. Dose prediction for repurposing nitazoxanide in SARS-CoV-2 treatment or chemoprophylaxis. medRxiv [Preprint]. 2020 May 6:2020.05.01.20087130. doi: 10.1101/2020.05.01.20087130.

  PMID: 32511548 BACKGROUND

• Pepperrell T, Pilkington V, Owen A, Wang J, Hill AM. Review of safety and minimum pricing of nitazoxanide for potential treatment of COVID-19. J Virus Erad. 2020 Apr 30;6(2):52-60. doi: 10.1016/S2055-6640(20)30017-0.

  PMID: 32405422 BACKGROUND

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

nitazoxanide

Condition Hierarchy (Ancestors)

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

Study Officials

• Patricia RM Rocco, MD, PhD

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients were randomly allocated into one of the two groups: A or B. Patients received labelled medication: A or B, by the pharmacist. Patients received an identification number, so care providers, outcomes assessors and investigators did not know anything regarding the patients' groups.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Investigator

Model Details: Patients diagnosed with COVID-19 will be randomly divided into 2 groups: experimental and control groups. Experimental group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receive nitazoxanide 500mg 8/8 hs for 5 days. Control group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receive placebo 8/8 hs for 5 days.

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 17, 2020
• Study Start: June 8, 2020
• Primary Completion: August 20, 2020
• Study Completion: September 5, 2020
• Last Updated: November 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Available as soon as the editorial board of the journal accepting the manuscript requires.
• Access Criteria: Editorial board of the Journal accepting the manuscript.

Locations

BR (1)