ESPERANSA study

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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.

Scientific title:

Study of the administration of HeberFERON compared to Heberon Alfa R in patients with COVID-19.

Secondary indentifying numbers:

IG/IAG/CV/2001

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana. Ministry of Public Health, Cuba.

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)

Reference number:

In process

Principal investigator

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

First name:

Idelsis

Last name:

Esquivel Moynelo

Medical Specialty :

Doctor in medicine. 1st degree specialist in Internal Medicine.

Affiliation:

Military Hospital "Dr. Luis Diaz Soto"

Postal address:

Ave Monumental 2 ½

City:

Havana

País:

Cuba

Zip Code:

19130

Telephone:

+53-7680000

Email address:

idelsisem@infomed.sld.cu

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:

Not applicable

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

10/04/2020

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:

Patients with SARS-COVID-2 infection

Intervention(s):

Group I-Experimental: HeberFERON (Interferon alfa ganma recombinante) HeberFERON (Interferon alfa ganma recombinante, 3.5 MIU), intramuscularly, 2-3 times per week for at least 3 consecutive weeks. Group II-Experimental: Heberon Alfa R (Recombinant Interferon alfa 2b) Heberon Alfa R (Recombinant Interferon alfa 2b, 3.0 MIU), intramuscularly, 2-3 times per week for at least 3 consecutive weeks.

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):

1) Negativization of SARS-Cov-2 RNA in positive patients after starting antiviral therapy (time in days). Measurement time: At baseline, on the 2nd and on the 4th day (1st week) and in weeks 2, 3 and 4 after antiviral treatment. 2) Progression to severe COVID-19 (time in days). Measurement time: At baseline, on the 2nd and on the 4th day (1st week) and in weeks 2, 3 and 4 after antiviral treatment.

Key secondary outcomes:

1) COVID-19 mortality rate (numerical value). Measurement time: at week 4 after antiviral therapy. 2) Rate of deterioration of the patients reclassified as severe (numerical value): Measurement time: During the time of the study (4 weeks). 3) Full compliance with the therapeutic regimen and patient evaluations. Measurement time: At baseline, on the 2nd and on the 4th day (1st week) and in weeks 2, 3 and 4 after antiviral treatment. 4) Medication adjustment due to poor prognosis, severe adverse events, or death. Measurement time: During the studio execution time (4 weeks). 5) Clinical Adverse Events (AE). They will be measured as: -AE occurrence (Yes, No), -AE description (name of the event), -AE intensity (mild, moderate, severe), -Causal relationship (unrelated, doubtful, possible, probable, Definitive), -Measures taken (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Exit of the study, Hospitalization / prolongation of hospitalization), -Result (Fully resolved, Resolved with sequelae, Conditions in improvement, Present condition and unchanged, worsening, death caused by this event). Measurement time: At baseline, on the 2nd and on the 4th day (1st week) and in weeks 2, 3 and 4 after antiviral treatment. 6) Levels of markers (at the RNA and serum levels) of response to IFNs (2-5OAS, Neopterin, β-2 microglobulin, Mx protein). Measurement time: At the beginning, on the 2nd and on the 4th day (1st week) and in weeks 2, 3 and 4 after antiviral treatment. 7) Activation of the immune system (expression of MHC-I / II, NK cells, cytotoxic T cells, activation of macrophages). Measurement time: At baseline, on the 2nd and on the 4th day (1st week) and in weeks 2, 3 and 4 after antiviral treatment.

Selection criterias

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

Gender:

Male/Female

Minimum age:

19 years

Maximum age:

None

Inclusion criteria:

1) SARS-CoV-2 positive patients by rapid or confirmatory qPCR tests. 2) Presence of any of the symptoms associated with the disease (fever, cough, dyspnea, interstitial changes in radiographic images) previous. 3) Voluntariness of the patient by signing the informed consent.

Exclusion criteria:

1) Patients with decompensated chronic diseases, or autoimmune diseases. 2) Known hypersensitivity to any of the components of the formulation under study. 3) Pregnancy or lactation. 4) Obvious mental incapacity to issue 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 trial

Masking:

Open

Control group:

Uncontrolled

Study design:

Parallel

Phase:

2

Target sample size:

60

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:

Iraldo

Last Name:

Bello Rivero

Specialty:

Doctor in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacán, Playa.

City:

La Habana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, 72087465

Email :

iraldo.bello@cigb.edu.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:

Iraldo

Last Name:

Bello Rivero

Specialty:

Doctor in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72085887, 72087465

Email :

iraldo.bello@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Military Hospital "Dr. Luis Díaz Soto"

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

09/04/2020

Postal address of Ethic Committee :

Ave Monumental 2 ½, Habana del Este, La Habana, C.P:19130, Cuba

Telephone:

53-7680000

Correo electrónico:

-

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

10

Study completion date:

30/07/2020

Date of available results:

15/08/2020

Date of first publication:

31/08/2020

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:

RPCEC00000307

Date of Registration in Primary Registry:

14/04/2020

Record Verification Date:

2020/04/14

Next update date:

2021/04/14

Link to the spanish version:

Click here

Versión para impresión

Ensayos Registrados

Proceso de Registro

ESPERANSA study

Acerca del RPCEC

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