Ignite Creation Date:
2024-05-06 @ 3:12 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04552483
Status:
COMPLETED
Last Update Posted:
2020-11-03
First Post:
2020-09-09
Brief Title:
Effects of Early Use of Nitazoxanide in Patients With COVID-19
Sponsor:
Universidade Federal do Rio de Janeiro
Organization:
Universidade Federal do Rio de Janeiro
Study Overview
Official Title:
Effects of Nitazoxanide Administration to Patients in the Initial Phase of COVID-19
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Multicenter randomized placebo-controlled parallel blinded interventional treatment clinical trial with two arms
Population 392 Patients with COVID-19 Coronavirus Disease-19 confirmed by RT-PCR Real Time polymerase chain reaction symptomatic in the early phase of the disease
Experimental group 196 patients nitazoxanide 500mg 8 8 hours for 5 days Control group 196 patients placebo 88 hours for 5 days
Population 392 Patients with COVID-19 Coronavirus Disease-19 confirmed by RT-PCR Real Time polymerase chain reaction symptomatic in the early phase of the disease
Experimental group 196 patients nitazoxanide 500mg 8 8 hours for 5 days Control group 196 patients placebo 88 hours for 5 days
Detailed Description:
SARITA-2 is a multicenter randomized placebo-controlled parallel -blinded interventional treatment clinical trial with two arms which aims to study the impact of nitazoxanide in the early phase of the COVID-19 Coronavirus Disease-19
Experimental group 196 patients received nitazoxanide 500mg 8 8 hours for 5 days Control group 196 patients received placebo 88 hours for 5 days
Population 392 Patients with COVID-19 confirmed by RT-PCR Real Time polymerase chain reaction symptomatic in the early phase of the disease
Calculation of the sample size was based on a previous study which demonstrated that 78 of Covid-19 patients in group 4 Hospitalized without oxygen therapy according to the WHO ordinal classification experienced complete resolution of symptoms after receiving placebo10 In the present trial patients were classified as group 2 Symptomatic and independent and a greater degree of recovery as measured by symptom-free days 80 was expected even after placebo Thus assuming an 11 increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo we would need approximately 196 patients per experimental group admitting a beta error of 15 and alpha error of 5 for a total n of 392 patients Calculation of the sample size was done by GPower 3192 Universität Düsseldorf Düsseldorf Germany
Experimental group 196 patients received nitazoxanide 500mg 8 8 hours for 5 days Control group 196 patients received placebo 88 hours for 5 days
Population 392 Patients with COVID-19 confirmed by RT-PCR Real Time polymerase chain reaction symptomatic in the early phase of the disease
Calculation of the sample size was based on a previous study which demonstrated that 78 of Covid-19 patients in group 4 Hospitalized without oxygen therapy according to the WHO ordinal classification experienced complete resolution of symptoms after receiving placebo10 In the present trial patients were classified as group 2 Symptomatic and independent and a greater degree of recovery as measured by symptom-free days 80 was expected even after placebo Thus assuming an 11 increase in symptom-free days in those patients who would receive nitazoxanide compared to placebo we would need approximately 196 patients per experimental group admitting a beta error of 15 and alpha error of 5 for a total n of 392 patients Calculation of the sample size was done by GPower 3192 Universität Düsseldorf Düsseldorf Germany
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RBR-4nr86m | OTHER | None | None |
| 32258920010015257 | OTHER | Comitê Nacional de Ética em Pesquisa CONEP | None |