Cardiovascular, renal and respiratory disorders in convalescent patients from SARS-CoV-2 infection COVID-19 SARS-CoV2
Conditions
Interventions
EPOCIM (Study group): 200,000 IU of ior®EPOCIM intravenously (IV), divided into 5 administrations of 40,000 IU, diluted in 100 ml of physiological saline, to be infused for 1 hour, on days 0, 3, 10, 1
Erythropoietin
ior® EPOCIM
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Willingness of the patient by signing the informed consent. 2. Subjects of any sex over 18 years of age. 3. Subjects who in the run-in check have hematocrit = 40 and higher hemoglobin = 9 g / L and =14g / L. 4. Subjects who maintain liver function tests in normal ranges or out of range in the pre-inclusion check-up without imminent compromise for life (clinical signs of hepatic encephalopathy and / or uremic coma). 5. Patients with cardiovascular sequelae, classified as classes II-III according to the functional scale of the New York Health Association (NYHA). 6. Patients with kidney sequelae with mild to moderate damage, according to the functional scale of the Kidney Disease Improving Global Outcome (KDIGO). 7. Patients with respiratory clinical manifestations and deterioration of respiratory function due to spirometric or radiological functional pattern. 8. Subjects of childbearing age who are using an adequate method of contraception prior to their inclusion in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women. 2. Patients with a history of thromboembolic disease in the last 3 to 6 months. 3. Patient with pre-existing cardiovascular diseases. 4. Patients with pre-existing renal failure, or undergoing treatment with extracorporeal clearance methods prior to SARS-CoV-2 infection. 5. Patients with pre-existing lung sequelae (including pulmonary fibrosis, COPD, severe asthma, lung cancer, etc.). 6. Patients with confirmed serious or life-limiting chronic disease. 7. Known hypersensitivity to any of the components of the formulation under study. 8. Subject that they are receiving another product under investigation. 9. Patients with obvious mental incapacity to give consent and act accordingly with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response to treatment: (favorable/unfavorable). Measurement time: month 1, month 3 and month 6. For cardiovascular sequelae will be considered favorable response to treatment when the patient progresses from greater to less cardiovascular damage according to the evaluative exercise stress test and according to the NYHA (New York Heart Association) classification. Unfavorable response: when, based on the above criteria, the patient progresses the greater the cardiovascular damage or the condition is not modified compared to the initial one). For renal sequelae will be considered favorable response to treatment in those patients who achieve clinical improvement given by moving from a category from higher to lower kidney damage, according to the KDIGO functional classification of kidney damage. Unfavorable response: Patients who do not change category or go to a higher category at the end of the study). For respiratory sequelae will be consider favorable response when the forced vital capacity (FVC) does not vary or is reduced by less than 10% in patients with pulmonary fibrosis and does not vary or is reduced by less than 5% in patients with another respiratory disorder with respect to the initial measurement. Unfavorable response: when the FVC is reduced more than 10% with respect to the initial measurement in patients with pulmonary fibrosis, and more than 5% in patients with another respiratory disorder). For mixed sequelae will be considered favorable response when: cuando alcanza el criterio de favorable para ambos tipos de secuelas. Respuesta desfavorable: cuando el criterio es desfavorable para al menos un secuela. Measurement time: At 1 month, month 3 and month 6. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: 1. Occurrence of any Adverse event- AE (yes / no). Measurement time: 6 months. 2. AE description (Name of the adverse event). Measurement time: 6 months. 3. Duration of the AE (Difference between the start and stop date of the event). Measurement time: 6 months. 4. Intensity of AE (1. Light, 2. Moderate 3. Severe, 5. Very severe 5. Death, according to Common Toxicity Criteria (CTCAE) version 5.0). Measurement time: 6 months. 5. Gravity (Seriousness) of AE (Critical event / No serious. Serious event (seriously) be considered as causing the death of the patient, life-threatening, results in hospitalization or prolongation of existing hospitalization, causes disability / persistent or significant disability, birth defects or congenital anomalies or an important medical event that according to medical judgment, could endanger the health of the patient or may require medical or surgical intervention to prevent the occurrence of any of the previously listed outcomes). Measurement time: 6 months. 6. Causality relationship (1. Definitive, 2.Very probable, 3. Probable, 4. Possible, 5. Unlikely, 6. unrelated, 7. Unknown). Measurement time: 6 months. 7. Attitude towards drug (1. No change 2. Dose reduction 3. Temporary discontinuation of treatment. 4. Definitive Treatment discontinuation). Measurement time: 6 months. 8. Outcome of the event (1. reversible effect, 2. Effect 3. Death 4. Irreversible loss of patient monitoring). Measurement time: 6 months. Effect: Specific variables for the stratum of patients with cardiovascular sequelae. 9. Alterations in the parietal thickness of ventricular walls (Yes / No. It is the increase in the dimensions of the heart muscle, expressed in mm. It will be considered normal from 8 to 11 mm or abnormal: if increased, equal to or greater than 12 mm). Measurement time: day 0 and month 1, month 3 and month 6. 10. Pulmonary hypertension (Yes / No. Calculation of the mean pressure of the pulmonary artery. Normal pulmonary pressure <35 mm | — |
Countries
Cuba
Contacts
Public ContactJuan Sanchez Moraguez
Saturnino Lora Hospital
Outcome results
None listed