ESPERANZA study

• Register: RPCEC
• Last refreshed on: 29 April 2024
• Main ID: RPCEC00000307
• Date of registration: 14/04/2020
• Prospective Registration: No
• Primary sponsor: Center for Genetic Engineering and Biotechnology (CIGB), in Havana
• Public title: ESPERANZA study
• Scientific title: Evaluation of the effect and safety of HeberFERON versus Heberon alfa in patients infected with the SARS-CoV-2 coronavirus (COVID-19).
• Date of first enrolment: 10/04/2020
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://rpcec.sld.cu/en/trials/RPCEC00000307-En
• Study type: Interventional
• Study design: Allocation: Randomized trial. Masking: Open. Control group: Active. Assignment: Parallel. Purpose: Treatment
• Phase: 2

Countries of recruitment

Cuba

Contacts

• Name: Iraldo Bello Rivero
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

• Name: Iraldo Bello Rivero
• Affiliation: Center for Genetic Engineering and Biotechnology (CIGB).

Key inclusion & exclusion criteria

Inclusion criteria: 1) Positivity to SARS-CoV-2 by rapid or confirmatory test of qPCR.
2) ECOG functional status = 2 (Karnofsky = 70%).
3) Voluntariness of the patient by signing the informed consent.
Exclusion criteria: 1) Patients with decompensated chronic diseases at the time of inclusion (severe arterial hypertension, ischemic heart disease, diabetes mellitus, etc.).
2) Patients with a history of autoimmune diseases.
3) Presence of hyperinflammation syndrome.
4) Serious coagulation disorders.
5) Known hypersensitivity to any of the components of the formulation under study.
6) Pregnancy or lactation.
7) Obvious mental incapacity to issue consent and act accordingly with the study.

Age minimum: 19 years
Age maximum: None
Gender: Male/Female

Health Condition(s) or Problem(s) studied

SARS Virus

Coronavirus Infections

Betacoronavirus

Coronaviridae Infections

covid-19

patients infected with the SARS-CoV-2 coronavirus.
covid-19

Intervention(s)

Group A: HeberFERON (Recombinant Interferon Alpha Gamma, 3.5 MUI), subcutaneously, twice a week for three consecutive weeks.
Group B (Control): Heberon Alfa R (Recombinant Interferon alfa 2b, 3.0 MUI), subcutaneously, three times per week for three consecutive weeks.
All the patients included in the study (as part of the protocol of action foreseen in the country for cases of SARS-CoV-2 in nasopharyngeal exudates) receive basic treatment (in addition to interferon according to study group) with caletra, chloroquine, azithromycin or rocefin, depending on the magnitude of respiratory symptoms.

Interferon-alpha

Interferon-gamma

Interferons

Chloroquine

Interferon alpha-2

Azithromycin

Injections, Subcutaneous

HeberFERON
Kaletra
Rocephin

Primary Outcome(s)

1) Virological evaluation: Time until the negativity of the SARS-Cov-2 RNA (absence of the virus according to the qPCR technique in real time) in positive patients after starting antiviral therapy (the percentage of patients negative for SARS will be calculated). VOC-2 by qPCR in tissue of nasopharyngeal exudate Measurement time: 48, 72 and 96 hours after starting treatment.
2) Clinical evaluation: Time to progression to severe COVID-19 (the percentage of patients who become severe will be calculated). Measurement time: 3rd week, after completion of the antiviral treatment under investigation.

Secondary Outcome(s)

1) Patients with unfavorable evolution (percentage of severe through clinical evaluations [fever, cough, dyspnea, etc.] and imaging (interstitial pneumonia by X-rays]). Measurement time: During the entire period of the study (three weeks).
2) Increase in the levels of markers (at the RNA and serum levels) of response to IFNs (2-5OAS, Neopterin, ß-2 microglobulin, Mx protein). The average value of the serum concentration measured by quantitative ELISA of 2´-5´OAS and Neopterin will be calculated. Measurement time: before starting treatment, and 7 and 14 days after starting treatment.
3) Increased activation of the immune system (MHC-I / II expression, NK cells, cytotoxic T cells, macrophage activation). The percentage of activated cells will be calculated from the total number of patients who will receive treatment. Measurement time: before starting treatment, and 14 days after treatment.
4) 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 some 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: daily throughout the study period (three weeks).

Secondary ID(s)

IG/IAG/CV/2001

Source(s) of Monetary Support

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

Secondary Sponsor(s)

Not applicable

Ethics review

Status: Approved
Approval date: 09/04/2020
Contact:

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Military Hospital "Dr. Luis Díaz Soto"

53-7680000

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Results

• Results available: Yes
• Date Posted: 15/08/2020
• Date Completed: 15/08/2020