Trial | NCT04348409  Report issue

Title

Efficacy and Safety of Nitazoxanide for the Treatment of Hospitalized Patients With Moderate COVID-19
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.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    50
This is a proof of concept study to evaluate the efficacy of nitazoxanide (600 mg BID) to treat hospitalized patients with moderate COVID-19.
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.
Study Started
May 25
2020
Primary Completion
Dec 31
2020
Study Completion
Dec 31
2020
Last Update
Oct 28
2022

Drug Nitazoxanide Tablets

Patients will receive nitazoxanide 600 mg BID for 7 days

Drug Placebo

Patients will receive placebo BID for 7 days

nitazoxanide Experimental

Patients will receive nitazoxanide 600 mg BID for 7 days.

Placebo Placebo Comparator

Patients will receive placebo BID for 7 days

Criteria 

Inclusion Criteria:

Informed consent from patient or legal representative.
Male or female, aged ≥ 18 years;
Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source;
Signs of respiratory failure requiring oxygen therapy
Hospitalized for up to 36h with non-invasive ventilation
Negative result for pregnancy test (if applicable).

Exclusion Criteria:

Participating in another RCT in the past 12 months;
Known allergy to nitazoxanide
Severely reduced LV function;
Severely reduced renal function;
Pregnancy or breast feeding;
Use of hydroxychloroquine and/or azithromycin in the past 15 days;
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
No Results Posted