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

covid19 Clinical Trial

Official title:

Prospective, Randomized, Double-blind, Parallel, Placebo Controlled Study to Evaluate the Safety and Efficacy of Nitazoxanide 600 mg to Treat Ambulatory Adult Subjects Diagnosed With COVID-19 With Mild Symptoms Assisted in the Public Health System of the City of Mesquita

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04441398
• Other study ID #: NITFQM0720OR
• Status: Withdrawn
• Phase: Phase 2/Phase 3
• Start date: July 2020
• Est. completion date: September 2020

Study information

• Verified date: October 2022
• Source: Azidus Brasil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• covid19

Intervention

Drug:
• Nitazoxanide
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 for 7 days. Treatment can be extended for another 7 days at Investigators discretion.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Azidus Brasil	Farmoquimica S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence of Treatment-Emergent Adverse Events	Number of participants with treatment-related adverse events	21 days
Secondary	The proportion of subjects hospitalized after start of treatment and before the end of the study	Change in clinical condition - 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)	21 days
Secondary	The proportion of subjects that need mechanical ventilation after start of treatment and before the end of the study	Change in clinical condition - 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)	21 days
Secondary	Duration of symptoms	Time required (days) to full symptom recovery	21 days
Secondary	Rate of mortality within 21-days	Evaluation of change in acute respiratory syndrome	21 days