Revisions for ior®EPOCIM in post-COVID-19 convalescent patients with cardiovascular, renal and/or respiratory disorders | Registro Público Cubano de Ensayos Clínicos

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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Acronym of Public Title:

COREPOCIM

Scientific title:

Safety and effect of ior®EPOCIM in convalescent patients from SARS-CoV-2 infection with cardiovascular, renal and/or respiratory sequelae. (COVID-19)

Acronym of Scientific Title:

COREPOCIM

Secondary indentifying numbers:

In process

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

30/11/2021

Reference number:

574/05.017.21BNV

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Juan

Midle name:

Carlos

Last name:

Sanchez Moraguez

Medical Specialty :

First Degree Specialist in Internal Medicine

Affiliation:

Saturnino Lora Hospital

Postal address:

Avenida de Los Libertadores s/n, entre 4ta y 6ta, Reparto Suenno

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90100

Telephone:

+53-22654806

+53-54202057

Email address:

jsanchezm@infomed.sld.su

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Pinar del Rio, Abel Santamaria Hospital, Felix Eduardo Lugo, MD, First Degree Specialist in Nephrology

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

07/01/2022

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Cardiovascular, renal and respiratory disorders in convalescent patients from SARS-CoV-2 infection

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

/complications

Respiratory Tract Infections

Cardiovascular Infections

Kidney Diseases

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

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, 17 and 21. They will also receive the best support treatment for cardiovascular, kidney and/or respiratory disorders post-COVID-19 available in Cuba during the development of the research. This can include statins, antischemic drugs, antiarrhythmics, antiplatelet drugs, etc. If respiratory sequelae, treatment may also include steroids (without exceeding a total daily dose of 60 mg / day for 14 days and / or weekly gradual reduction), bronchodilators, antibiotics in case of infection, oxygen therapy and / or pulmonary rehabilitation. The research team should assess the possible drug combinations, according to the type of sequelae and characteristics of the available drugs. Control group: They will receive the best support treatment for cardiovascular, kidney and/or respiratory disorders post-COVID-19 available in Cuba during the development of the research. In each group the patients will be divided in 4 subgroups according to the type of sequelae: Subgroup I: Patients with cardiovascular sequelae Subgroup II: Patients with kidney sequelae Subgroup III: Patients with respiratory sequelae Subgroup IV: Patients with mixed sequelae: cardiovascular, kidney and / or respiratory.

Intervention code:

Erythropoietin

Infusions, Intravenous

Intervention keyword:

ior® EPOCIM

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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.

Key secondary outcomes:

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 mmHg or pulmonary hypertension ≥ 35 mmHg will be considered). Measurement time: day 0 and month 1, month 3 and month 6. 11. Presence of intracardiac masses (Yes / No. Echocardiographic evidence of infrequent entities in the heart. If so, define: Thrombi, Tumors, Cysts, Vegetations, or others). Measurement time: day 0 and month 1, month 3 and month 6. 12. Alterations in the volume of cavities (Yes / No. Increase in the volumes of the different cardiac chambers expressed in ml. It will be classified into normal volumes or augmented volumes). Measurement time: day 0 and month 1, month 3 and month 6. 13. Valvular alterations (Yes / No. Modifications of the function and structure of the valve apparatus (mitral, tricuspid or pulmonary). If so, it is classified as: aortic, stenosis or insufficiency). Measurement time: day 0 and month 1, month 3 and month 6. 14. Alterations in left ventricular ejection fraction-LVEF (Yes / No. It is the fraction of the blood volume of the left ventricle expelled in systole (stroke volume) in relation to the volume of blood in it at the end of the diastole. If so, it is classified as: mild dysfunction: LVEF 46% to 55%, moderate dysfunction: LVEF 36% to 45%, severe dysfunction: LVEF less than or equal to 35% or, normal: LVEF greater than 55%). Measurement time: day 0 and month 1, month 3 and month 6. 15. Segmental contractibility (Yes / No. It is the contractile capacity of the heart by segments (mitral, tricuspid or pulmonary) determined by tissue Doppler (TDI). In case of abnormality, it is classified as: hypokinesia, akinesia or, normokinesia). Measurement time: day 0 and month 1, month 3 and month 6. 16. Presence of functional disorders (Yes / No. Determination of functional disorders due to systolic or diastolic dysfunction or both, structural due to anatomical alterations of the wall, partitions and valves, and mixed with a combination of the previous two. They are classified into functional disorders, structural disorders, or mixed disorders). Measurement time: day 0 and month 1, month 3 and month 6. Specific variables for the stratum of patients with renal sequelae. 17. Abnormal serum creatinine (the normal value is 0.7 to 1.3 mg / dL (61.9 to 114.9 µmol / L) for men and 0.6 to 1.1 mg / dL (53 to 97.2 µmol / L) for women). Measurement time: day 0 and month 1, month 3 and month 6. 18. Creatinine clearance (It is the test of renal function based on the rate of excretion by the kidneys of endogenous creatinine produced metabolically. Its reference value: 60 to 140 ml / min / 1.73m2SC. It will be measured from the Cockcroft-Gault formula based on serum creatinine). Measurement time: day 0 and month 1, month 3 and month 6. 19. Proteinuria (Measures the presence of protein in a random urine sample, normal values are 0 to 14 mg/dL). Measurement time: day 0 and month 1, month 3 and month 6. 20. Microalbuminuria (Measures the presence of albumin in the urine. Their reference values: 300 µg / mg or 30-300 mg/g). Measurement time: day 0 and month 1, month 3 and month 6. 21. Kidney size (in mm. It will be classified as: Normal (100 to 120 x 40 to 60), increased, or decreased with respect to the initial value). Measurement time: day 0 and month 1, month 3 and month 6. 22. Renal parenchyma (thickness in mm. In sagittal section on the internal contour. It will be classified as: normal (10 to 12 mm), increased or decreased, with respect to the initial value). Measurement time: day 0 and month 1, month 3 and month 6. 23. Echogenicity (It will be classified as: normal (10 to 12 mm), increased or decreased from the initial value). Measurement time: day 0 and month 1, month 3 and month 6. 24. Ecotexture (Homogeneous or heterogeneous). Measurement time: day 0 and month 1, month 3 and month 6. 25. Sine-parenchyma relationship (It will be classified as: normal (10 to 12), increased or decreased with respect to the initial value). Measurement time: day 0 and month 1, month 3 and month 6. 26. Presence of focal lesion (Yes / No). Measurement time: day 0 and month 1, month 3 and month 6. 27. Number of lesions (A total number of lesions). Measurement time: day 0 and month 1, month 3 and month 6. 28. Location (Localization of the injuries). Measurement time: day 0 and month 1, month 3 and month 6. 29. Extension of the lesion (for each one, in mm). Measurement time: day 0 and month 1, month 3 and month 6. 30. Other possible alterations (Yes / No. Dilation of the excretory system, alterations in the location, presence of lithiasis or congenital malformation). Measurement time: day 0 and month 1, month 3 and month 6. Specific variables for the stratum of patients with respiratories sequelaes 31. Maximum expiratory volume-VEM (It is the fraction of the forced vital capacity that can expire in the first second in a forced expiration after a maximum inspiration, observed value in ml). Measurement time: on days 0, 63 and 182. 32. Number of lesions (number of lesions that the patient presents at each moment of evaluation, measured by CT). Measurement time: day 0 and month 1, month 3 and month 6. 33. Type of lesion (nonspecific pulmonary fibrosis, tarnished virio pattern, reticulo-nodular pattern, or other). Measurement time: day 0 and month 1, month 3 and month 6. 34. Lesion location (In the right lung (Upper lobe: anterior, posterior or apical, Middle lobe: medial or lateral, or Lower lobe: apical, anterior, posterior, internal, external). In the left lung (Upper lobe: apical posterior, anterior, superior lingular, inferior lingular, Lower lobe: apical, anterior, posterior, external)). Measurement time: day 0 and month 1, month 3 and month 6. 35. Extension of the lesion (Area of the lesion in cm2). Measurement time: day 0 and month 1, month 3 and month 6. 36. Modification of the measurable lesion according to extension (increase, no variation or reduction). Measurement time: day 0 and month 1, month 3 and month 6. 37. Number of affected segments for non-measurable lesions (Number of affected segments). Measurement time: day 0 and month 1, month 3 and month 6. 38. Variation of the non-measurable lesion (increase, no variation or reduction). Measurement time: day 0 and month 1, month 3 and month 6. 39. Anti-RBD antibody titers (The antibody titers in response to vaccination will be determined in each patient). Measurement time: day 0 and month 1, month 3 and month 6. 40. Neutrophil/lymphocyte ratio (The neutrophil / lymphocyte ratio will be determined from the blood count values). Measurement time: day 0 and month 1, month 3 and month 6. 41. Platelet/lymphocyte ratio (The platelet / lymphocyte ratio will be determined from the values of the blood count). Measurement time: day 0 and month 1, month 3 and month 6. 42. Absolute count of CD4 + T cells (The amount and percentage of CD4 + T cells in the blood will be determined). Measurement time: day 0 and month 1, month 3 and month 6. 43. Absolute count of CD8 + T cells (The amount and percentage of CD8 + T cells in the blood will be determined). Measurement time: day 0 and month 1, month 3 and month 6. 44. Absolute count of CD28+ T cells (The percentage of CD8 + CD208- T cells in the blood will be determined). Measurement time: day 0 and month 1, month 3 and month 6. 45. CD4 / CD8 index (The CD4 / CD8 index in blood will be determined). Measurement time: day 0 and month 1, month 3 and month 6.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

18 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

135

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Juan

Middle Name:

Carlos

Last Name:

Sanchez Moraguez

Specialty:

First Degree Specialist in Internal Medicine

Affiliation:

Saturnino Lora Hospital

Postal Address:

Avenida de Los Libertadores s/n, entre 4ta y 6ta, Reparto Suenno

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90100

Telephone:

+53-22645447

Email :

jsanchezm@infomed.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Juan

Middle Name:

Carlos

Last Name:

Sánchez Moráguez

Specialty:

First Degree Specialist in Internal Medicine

Affiliation:

Saturnino Lora Hospital

Postal Address:

Avenida de Los Libertadores s/n, entre 4ta y 6ta, Reparto Suenno

City:

Santiago de Cuba

Country:

Cuba

Zip Code:

90100

Telephone:

+53-22645447

Email :

jsanchezm@infomed.sld.cu

Research Ethics Committees

Section to complete the data related to the review ethics committees.

Name of Research Ethics Committees:

Saturnino Lora Hospital

Abel Santamaria Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

17/05/2021

21/05/2021

Postal address of Ethic Committee :

Avenida de Los Libertadores s/n, entre 4ta y 6ta, Reparto Suenno, ZC 90100, Santiago de Cuba, Cuba.

Carretera Central No.km 3½, Hermanos Cruz. ZC 20200, Pinar del Rio, Cuba.

Telephone:

+53-22643990

+53-48762068

Email:

liudmila.castro@infomed.sld.cu

victorj@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

30/12/2023

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000376

Date of Registration in Primary Registry:

18/06/2021

Record Verification Date:

2021/12/27

Next update date:

2022/12/27

Link to the spanish version:

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Registered Trials

Registration process

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

About the RPCEC

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