ior®EPOCIM in post-COVID-19 convalescent patients with cardiovascular, renal and/or respiratory disorders

Phase 2

• Conditions: Cardiovascular, renal and respiratory disorders in convalescent patients from SARS-CoV-2 infection; COVID-19; SARS-CoV2; Coronavirus Infections; SARS Virus; Coronaviridae Infections; Betacoronavirus; /complications; Respiratory Tract Infections; Cardiovascular Infections

• Registration Number: RPCEC00000376
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-18
• Study Completion: 2024-03-30
• Results First Posted: 2024-05-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 135

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified