U07.1 COVID-19, virus COVID-19, virus
Conditions
Interventions
. Carrimicina (400 mg) o placebo todos los dias durante 14 dias (2 comprimidos de 200 mg), tomada despues de una comida
si un paciente experimenta un problema de alimentacion, carrimicina se tomara sin alimentos. Si no se puede tomar la intervencion del estudio, se puede administrar por sonda nasogastrica. Cada adminis
Sponsors
Shenyang Tonglian Group Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Hospitalized male or non-pregnant female adult patient = 18 years of age at the time of enrollment with signed informed consent. 2. Patient with SARS-CoV-2 infection as determined by RT-PCR or other commercial or public health assay in any specimen taken = 4 days prior to randomization. Patient with a second SARS-CoV-2 episode after resolution of the initial infection may be enrolled if the infection is reconfirmed by RT-PCR and all other eligibility criteria are met. 3. Patient hospitalized, who are requiring supplemental oxygen via nasal cannula, non-invasive ventilation or high-flow oxygen to maintain peripheral oxygen saturation of at least 92% at time of Screening 4. Female patients of childbearing potential and male patients with female partner of childbearing potential must agree to use at least one primary form of contraception for the duration of the study (applicable methods will be determined by the site but may include barrier contraceptives [male condom, female condom or diaphragm with a spermicidal gel], abstinence, hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches or contraceptive rings] and intrauterine devices) .5. Ability to provide informed consent personally, or by a legally acceptable representative if the patient is unable to do so. 6. Patient is willing and able to comply with all required study visits and follow-up required by the protocol. 7. Patient must agree not to enroll in another study of an investigational agent prior to completion of Day 60 of study
Exclusion criteria
Exclusion criteria: 1. Pacientes no hospitalizados, con limitacion de las actividades y/o necesidad de soporte de oxigeno en el hogar. 2. Paciente con una depuracion de creatinina 2 mmol/l [18 mg/dl] a pesar de la reanimacion con el volumen adecuado). 18. Paciente que requiere ventilacion mecanica u oxigenacion con membrana extracorporea en la seleccion. 19. El paciente tiene un intervalo QT corregido medio utilizando la formula de Fridericia (QTcF) de >450 ms (para participantes de sexo masculino) y >470 ms (para participantes de sexo femenino) en la seleccion. Si el intervalo QTcF medio supera los limites anteriores, se puede realizar un electrocardiograma (ECG) por triplicado adicional. 20 Paciente que tiene antecedentes de abuso de alcohol dentro de los 3 meses previos al
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mantel-Haenszel common probability difference (across strata used in the randomization) between treatment groups (carrimycin minus placebo) along with a two-sided 95% Mantel-Haenszel C NAME OF THE RESULT: Patients without need for supplementary oxigen at day 28 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 28. | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to the event variables will be summarized with Kaplan-Meier curves and 95% confidence bounds of the median time. The stratified log-rank test will be used to calculate p-values. Hazard ratio for group comparison (carrimycin minus placebo) and its corresponding 95% CI will be calculated using Cox Proportional Hazard model. Where appropriate, a competing risk or multi-state approach will be applied. Continuous variables, including the changes from baseline, will be summarized by the mean, standard deviation (SD), median, and the range. The Mixed Model with Repeated Measurements (MMRM) or Analysis of Covariance (ANCOVA) will be used to estimate group difference (carrimycin minus placebo) at a specific time point. The least square means, standard errors, 95% CIs and p-values will be presented. The secondary efficacy endpoints will be statistically tested in a hierarchical order to restrict the one-sided family-wise type I error probability to 0.025. NAME OF THE RESULT: Efficay and Safety of Carrimicina PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Days: 3, 7, 14 y 28 ;Mantel-Haenszel common probability difference (across strata used in the randomization) between treatment groups (carrimycin minus placebo) along with a two-sided 95% Mantel-Haenszel C NAME OF THE RESULT: Patients without need for supplementary oxigen at day 28 PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Day 28. | — |
Countries
Argentina, Brazil, Colombia, India, Mexico, Peru, Philippines, United States
Contacts
Public ContactBERTHA DEL PILAR CABRERA
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed