COVID-19 trials registries data warehouse

https://rpcec.sld.cu/en/trials/RPCEC00000376-En

Juan Sanchez Moraguez

jsanchezm@infomed.sld.cu

2021-06-18

Not recruiting

RCT

Randomized

Parallel

Open label

single-center

Long covid

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.

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.

2

Center of Molecular Immunology (CIM)

18

100

Cuba

Patients recovered from covid

N/A

135

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.

Phase 2

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