Efficacy and Safety of Nitazoxanide 600 mg to Treat Mild Ambulatory COVID-19 Patients

NCT04441398 | Withdrawn Phase 2

• 1 other identifier: NITFQM0720OR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim is to demonstrate a decrease in complications among ambulatory patients who are diagnosed with mild COVID-19 by treating them with nitazoxanide for 7 to 14 days on top of standard care compared to patients who receive standard care and placebo only.

Conditions

covid19

Outcome Measures

Primary Outcomes (1)

• Change in signs and symptoms scale

  Symptoms will be assessed using a 5 point scale (1- excellent, 2- good, 3- fair, 4 - poor 5 - very poor).

  21 days

Secondary Outcomes (5)

• Incidence of Treatment-Emergent Adverse Events

  21 days

• The proportion of subjects hospitalized after start of treatment and before the end of the study

  21 days

• The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study

  21 days

• Duration of symptoms

  21 days

• Rate of mortality within 21-days

  21 days

Study Arms (2)

nitazoxanide

EXPERIMENTAL

Subjects will receive nitazonanide 600 mg TID.

Drug: Nitazoxanide

Placebo

PLACEBO COMPARATOR

Subjects will receive placebo TID.

Drug: Placebo

Interventions

Nitazoxanide DRUG

Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.

Also known as: Viranitta

nitazoxanide

Placebo DRUG

Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.

Placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent from patient or legal representative.
• Subject of both genders (male and female not pregnant and not breastfeeding) aged over 49;
• Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
• Symptomatic subject with symptoms for up to 72 hours who does not require hospitalization, with signs and symptoms of acute respiratory viral infection characterized by a feverish sensation or fever, which may or may not be present at the time of the examination (which may be reported to the health professional), accompanied by cough or sore throat or runny nose or difficulty breathing and:
• i) Oxygen saturation ≥ 90%; ii) Risk classification for COVID-19 between low (A) or medium (B) (scores 1 to 19), according to the Brazilian Ministry of Health.

You may not qualify if:

• Participating in another RCT in the past 12 months;
• Presence of comorbidities, which have a contraindication to the use of the study product, not being restricted to:
• HIV or HTLV virus infection;
• Chronic hepatitis C (HCV) treated with direct antiviral drugs;
• Liver failure;
• Severe renal failure, including dialysis;
• Present hypersensitivity to the study product (nitazoxanide), as well as to related compounds;
• Concomitant administration of drugs that may interact with the product under study (nitazoxanide);
• Participants who underwent treatment with other antiviral drugs;
• Subject in antineoplastic treatment with chemotherapy or radiation therapy;
• Subject with severe autoimmune diseases in immunosuppression;
• Transplanted participants;
• Pregnant or lactating women;
• Any other clinical condition that is deemed by the Investigator to be an imminent risk to the health and life of the subject.

Sponsors & Collaborators

• Azidus Brasil: lead
• Farmoquimica S.A.: collaborator

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

• Edimilson Migowski, MD

  NEPS SEMUS Mesquita

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: Subjects will be randomized to receive either nitazoxanide (n=150) or placebo (n=150)

Study Record Dates

• First Submitted: June 18, 2020
• First Posted: June 22, 2020
• Study Start: July 1, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 28, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share