Clinical trial NCT04423861: Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19
Official title: A Phase III, Multicentre, Parallel, Randomized, Double-blind Clinical Trial to Assess the Efficacy and Safety of Nitazoxanide 600 mg Compared to Placebo in the Treatment of Hospitalized Patients With COVID-19 in Non-critical Condition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: covid19
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Farmoquimica S.A.
First posted: 2020-06-09
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to receive either nitazoxanide 600 mg BID or Placebo (1:1)
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Need of mechanical ventilation
timeFrame: 14 days
Secondary outcomes:
measure: Change in the pulmonary condition
timeFrame: Baseline, Day 7 and Day 14
measure: Change in Clinical Condition
timeFrame: Baseline, Day 7 and Day 14
measure: Change in tomographic pulmonary condition
timeFrame: Baseline, Day 7
measure: Rate of mortality within 14-days
timeFrame: 14 days
measure: Change in inflammatory markers
timeFrame: Baseine, Day 7, Day 14
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital Vera Cruz
state: São Paulo
Study officials:
affiliation: +55 19 991232882
name: Florentino de Araujo Cardoso Filho, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: