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

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

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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