This study is a multi-center, randomized, double-blind, parallel, placebo-controlled, phase III clinical trial to evaluate efficacy and safety of pyramax in mild to moderate COVID-19 patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,807
Percentage of subjects who require hospitalization or have died due to COVID-19 infection until post-dose D29.
Time frame: follow up to Day29
Time to sustained recovery (discharge) in hospitalized subjects (days)
Time frame: follow up to Day29
29-day mortality after the first dose of the investigational product
Time frame: Day29
11-point WHO clinical progression scale for clinical symptoms at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline
Time frame: Day3, Day7, Day14, Day21, Day29
NEWS at D3, D7, D14, D21, and D29 after administration of the IP and changes compared to baseline
Time frame: Day3, Day7, Day14, Day21, Day29
Percentage of subjects requiring acute therapy for more than 24 hours in a hospital or acute treatment facility or who have died due to COVID-19 until D29 after administration
Time frame: follow up to Day29
Percentage of subjects who have newly diagnosed with pneumonia or aggravated pneumonia* according to baseline pneumonia criteria until D29 after administration of the IP
Time frame: follow up to Day29
Change from baseline in COVID-19 viral load at D2, D3, D5, D7, and D14
Time frame: Day2, Day3, Day5, Day7, Day14
Percentage of subjects in the high-risk group** who require hospitalization or have died due to COVID-19 until post-dose D29
Time frame: follow up to Day29
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Instituto Medico Platense
Buenos Aires, Argentina
Ciprec - Centro de Investigación Y Prevención Cardiovascular
Caba, Argentina
Hospital de Agudos "Dr. Ignacio Pirovano"
Caba, Argentina
Instituto Médico Río Cuarto
Córdoba, Argentina
Clinica Privada Independencia
Munro, Argentina
Centro Médico IPAM
Santa Fe, Argentina
Icegclinic
La Florida, Santiago Metropolitan, Chile
Clínica Universidad de los Andes
Las Condes, Santiago Metropolitan, Chile
Hospital Regional Dr. Leonardo Guzman de Antofagasta
Antofagasta, Chile
Centro de Estudios Clínicos e Investigaciones Médicas - CECIM
Santiago, Chile
...and 56 more locations