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

NCT ID: NCT04441398

Last Updated: 2022-10-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-31
• Study Completion Date: 2020-09-30

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.

Detailed Description

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.

After 7 days of treatment, the Investigator can extend the treatment duration for another 7 days at his/her discretion.

Conditions

covid19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

nitazoxanide

Subjects will receive nitazonanide 600 mg TID.

Group Type: EXPERIMENTAL

Nitazoxanide

Intervention Type: DRUG

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

Placebo

Subjects will receive placebo TID.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Nitazoxanide

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Viranitta

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Farmoquimica S.A.

INDUSTRY

Sponsor Role: collaborator

Azidus Brasil

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Edimilson Migowski, MD

Role: PRINCIPAL_INVESTIGATOR

NEPS SEMUS Mesquita

Other Identifiers

NITFQM0720OR

Identifier Type: -

Identifier Source: org_study_id