Status:
UNKNOWN
Efficacy and Safety Study of Nitazoxanide (NTX) in the Treatment of Patients With SARS-CoV-2 Virus Infection (COVID-19)
Lead Sponsor:
Laboratorios Roemmers S.A.I.C.F.
Conditions:
COVID-19
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
PHASE3
Brief Summary
Evaluation of the efficacy and safety of NTX in adult patients (≥18 years and \<60 years), with SARS-CoV-2 infection with mild symptoms of COVID-19, compared to a placebo control arm. 135 patients wil...
Detailed Description
The rapid spread of COVID-19 has overwhelmed the capabilities of the Public Health System in major nations due to the large number of critically ill patients and patients seriously affected requiring ...
Eligibility Criteria
Inclusion
- Adult male and female patients (≥ 18 years and \<60 years).
- Signature of informed consent.
- Patients with a positive test for SARS-CoV-2 and mild symptoms of COVID-19 (without severity criteria as detailed by the Ministry of Health of Argentina - MSN)
Exclusion
- Patients under 18 years of age and over 60 years of age.
- Breastfeeding or pregnant women (with positive pregnancy blood test in women of childbearing age).
- Patients with mild pneumonia in the presence of risk factors or moderate or severe pneumonia (based on the severity criteria set by the Ministry of Health of Argentina), or patients who require mechanical ventilation at screening.
- Patients in whom NTX and/or lactose is contraindicated.
- Any other contraindication based on the judgment of the treating physician.
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2020
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT04463264
Start Date
June 26 2020
End Date
December 26 2020
Last Update
October 8 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Austral
Presidente Derqui, Buenos Aires, Argentina, Argentina, 1629