Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19

Proof of Concept, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Safety and Efficacy of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Moderate Condition.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04348409

Enrollment

Registered

2020-04-16

Start date

2020-05-25

Completion date

2020-12-31

Last updated

2022-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Brief summary

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.

Detailed description

This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19. The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide for 7 days on top of standard care compared to patients who receive standard care and placebo. Patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide or placebo.

Interventions

DRUGNitazoxanide Tablets

Patients will receive nitazoxanide 600 mg BID for 7 days

DRUGPlacebo

Patients will receive placebo BID for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Patients will be randomized to receive either nitazoxanide or placebo (1:1).

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Informed consent from patient or legal representative. 2. Male or female, aged ≥ 18 years; 3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source; 4. Signs of respiratory failure requiring oxygen therapy 5. Hospitalized for up to 36h with non-invasive ventilation 6. Negative result for pregnancy test (if applicable).

Exclusion criteria

1. Participating in another RCT in the past 12 months; 2. Known allergy to nitazoxanide 3. Severely reduced LV function; 4. Severely reduced renal function; 5. Pregnancy or breast feeding; 6. Use of hydroxychloroquine and/or azithromycin in the past 15 days; 7. 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

Design outcomes

Primary

Measure	Time frame	Description
Viral load	day 1, 4, 7, 14 and 21	PCR will be done to evaluate the change in viral load

Secondary

Measure	Time frame	Description
Evolution of acute respiratory syndrome	21 days	Time to wean off oxygen supplementation
Change in Clinical Condition	21 days	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)
Hospital discharge	21 days	Time to be discharged from hospital
Rate of mortality within 21-days	21 days	Evaluation of change in acute respiratory syndrome
Need of mechanical ventilation	21 days	Evaluation of change in acute respiratory syndrome

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026