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

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Azidus

Status and phase

Enrolling
Phase 3

Conditions

covid19

Treatments

Drug: Placebo
Drug: Nitazoxanide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04423861
NITFQM0920OR-III

Details and patient eligibility

About

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.

Full description

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.

Enrollment

380 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

  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%;

  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. 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

380 participants in 2 patient groups, including a placebo group

nitazoxanide BID
Experimental group
Description:
Patients will receive nitazoxanide 600 mg BID for 7 days.
Treatment:
Drug: Nitazoxanide
Placebo
Placebo Comparator group
Description:
Patients will receive matching placebo BID for 7 days.
Treatment:
Drug: Placebo

Trial contacts and locations

1

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Central trial contact

Luciana Ferrara; Florentino de Araujo Cardoso Filho, MD, PhD

Data sourced from clinicaltrials.gov

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