Clinical trial NCT04348409: Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Lead sponsor: Azidus Brasil
Sponsor class: INDUSTRY
Collaborators: name: Farmoquimica S.A.
name: Hospital Vera Cruz
name: Hospital Casa de Saúde - Vera Cruz - Campinas - SP - Brazil
name: Centro de Genomas - UNIFESP
name: Emilio Ribas Institute of Infectious Diseases
First posted: 2020-04-16
Enrollment: 50
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 or placebo (1:1).
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Viral load
timeFrame: day 1, 4, 7, 14 and 21
Secondary outcomes:
measure: Evolution of acute respiratory syndrome
timeFrame: 21 days
measure: Change in Clinical Condition
timeFrame: 21 days
measure: Hospital discharge
timeFrame: 21 days
measure: Rate of mortality within 21-days
timeFrame: 21 days
measure: Need of mechanical ventilation
timeFrame: 21 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Hospital Vera Cruz
state: São Paulo
city: São Paulo
country: Brazil
facility: Centro de Genomas
city: São Paulo
country: Brazil
facility: Hospital Emílio Ribas
Study officials:
References:
citation: Blum VF, Cimerman S, Hunter JR, Tierno P, Lacerda A, Soeiro A, Cardoso F, Bellei NC, Maricato J, Mantovani N, Vassao M, Dias D, Galinskas J, Janini LMR, Santos-Oliveira JR, Da-Cruz AM, Diaz RS. Nitazoxanide superiority to placebo to treat moderate COVID-19 - A Pilot prove of concept randomized double-blind clinical trial. EClinicalMedicine. 2021 Jul;37:100981. doi: 10.1016/j.eclinm.2021.100981. Epub 2021 Jun 27.