Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-22

Study Completion Date

2023-03-31

Brief Summary

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This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

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Detailed Description

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This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical 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 BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..

Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.

Conditions

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covid19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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nitazoxanide BID

Patients will receive nitazoxanide 600 mg BID for 7 days.

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

Patients will receive nitazoxanide 600 mg BID for 7 days.

Placebo

Patients will receive matching placebo BID for 7 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Patients will receive matching placebo BID for 7 days.

Interventions

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Nitazoxanide

Patients will receive nitazoxanide 600 mg BID for 7 days.

Intervention Type DRUG

Placebo

Patients will receive matching placebo BID for 7 days.

Intervention Type DRUG

Other Intervention Names

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Viranitta (Nitazoxanide)

Eligibility Criteria

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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
4. chain reaction (RT-PCR) from any diagnostic sampling source;
5. Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation \<98%;

7\. 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. Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
7. History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
8. Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
9. Diagnose of severe autoimmune diseases in immunosuppression;
10. Transplanted patients;
11. 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No