Revisions for Heberon Alfa R in COVID-19 | Registro Público Cubano de Ensayos Clínicos

--- 29 May 2020 - 12:54pm by Gladys
+++ 23 March 2023 - 1:12am by Gladys
+Coronavirus Infections
+Coronaviridae Infections
+Nidovirales Infections
+RNA Virus Infections
+Virus Diseases
+COVID-19
+SARS-CoV2
+Interferon-alpha
+Injections, Intramuscular
+Heberon Alfa R
-/05/29
+/09/14
-/05/29
+/09/14

Revision of 23 March 2023 - 1:12am:

Heberon Alfa R in COVID-19

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:

Use of Heberon® Alfa R in patients confirmed for infection with SARS-CoV-2 in Cuba. Observational clinical study. (COVID-19)

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Ministry of Public Health

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:

Only approved by Ethics Committees

Principal investigator

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

First name:

Ricardo

Last name:

Pereda Gonzalez

Medical Specialty :

2nd Degree Specialist in Intensive Medicine and Emergencies. 1st Degree Specialist in Internal Medicine

Affiliation:

Medical Science College of Havana

Postal address:

23 Street, 202, Vedado, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78383880

+53-52886135

Email address:

pereda.gonzalez@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:

Havana, Pedro Kouri Institute, Dr.Daniel Gonzalez Rico, Internal Medicine

Havana, Enrique Cabrera General Hospital, Dr. Hubert Blas Rivero Martinez, Internal Medicine

Havana, Miguel Enriquez Hospital, Dr. Juan Carlos Rivero Lopez, Intensive Medicine

Havana, Enrique Cabrera General Hospital, Dr.C. Albadio Perez Aseff, Intensive Medicine

Havana, Juan Manuel Marquez Pediatric Hospital, Dra. Lissette del Rosario Lopez Gonzalez, Intensive Medicine

Havana, Miguel Enriquez Hospital, Dra.C Natacha Mezquia de Pedro, Intensive Medicine

Havana, Luis Diaz Soto Central Military Hospital, Dr. Rafael Venegas Rodriguez, Intensive Medicine

Villa Clara, Manuel Fajardo Military Hospital, Dr.C Julio R. Betancourt Cervantes, Intensive Medicine

Camaguey, Octavio de la Concepcion y la Pedraja Military Hospital, Dr. Rodolfo Emilio Dominguez Rosabal, Intensive Medicine

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

11/03/2020

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 confirmed SARS-CoV-2 infection

Health condition(s) code:

Coronavirus Infections

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Virus Diseases

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

IFN-α2b 3 million IU (Heberon® Alpha R), intramuscularly, 3 times per week, for 2 weeks

Intervention code:

Interferon-alpha

Injections, Intramuscular

Intervention keyword:

Heberon Alfa R

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):

Proportion of patients discharged from the hospital (Patients with clinical discharge of the confirmed case according to clinical, radiological and, laboratory criteria divided by the number of recruited patients). Measurement time: at the end of treatment (14 days). -Clinical criteria: The patient's condition is stable and afebrile for more than 3 days, regular breathing and normal respiratory rate, clear conscience, unaffected speech and normal diet. -Radiological criteria: Lung images show significant improvement without signs of organ dysfunction. -Laboratory criteria: Two consecutive negative respiratory pathogenic nucleic acid tests (at least one day between tests).

Key secondary outcomes:

Case Fatality Rate-CFR (Number of confirmed deaths divided by the number of number of recruited patients). Measurement time: at the end of treatment (14 days).

Selection criterias

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

Gender:

Male/Female

Minimum age:

None

Maximum age:

None

Inclusion criteria:

1. SARS-CoV-2 positive patients by rapid or confirmatory qPCR tests. 2. Informed consent granted.

Exclusion criteria:

1. Patients with chronic decompensated diseases, or autoimmune-type diseases. 2. Known hypersensitivity to any of the components of the formulation under study. 3. No Informed consent granted.

Type of population:

Children and Adults

Type of participant:

Patients

Study design

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

Type study:

Observational

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

4

Target sample size:

All patients confirmed as SARS-Cov-2 positive during the study

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:

Ricardo

Last Name:

Pereda Gonzalez

Specialty:

2nd Degree Specialist in Intensive Medicine and Emergencies. 1st Degree Specialist in Internal Medicine

Affiliation:

Medical Science College of Havana

Postal Address:

Street 23 202, Vedado, Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78383880, +53-52886135

Email :

pereda.gonzalez@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:

Ricardo

Last Name:

Pereda González

Specialty:

2nd Degree Specialist in Intensive Medicine and Emergencies. 1st Degree Specialist in Internal Medicine

Affiliation:

Medical Science College of Havana

Postal Address:

23 Street 202, Vedado, Plaza de la Revolucion.

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-78383880, +53-52886135

Email :

pereda.gonzalez@infomed.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

"Pedro Kouri" Tropical Medicine Institute (IPK)

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

10/03/2020

Postal address of Ethic Committee :

Avenida Novia del Mediodia, KM 6 1/2, La Lisa, La Habana, 11400, Cuba

Telephone:

+53-72020425

Email:

daniel@ipk.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

2005

Study completion date:

14/08/2020

Date of available results:

15/09/2020

Date of first publication:

30/11/2020

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:

RPCEC00000318

Date of Registration in Primary Registry:

29/05/2020

Record Verification Date:

2020/09/14

Next update date:

2021/09/14

Link to the spanish version:

Click here

Registered Trials

Registration process

Heberon Alfa R in COVID-19

About the RPCEC

Useful resources