Retrospective observational study of the administration of Jusvinza, for the management of COVID-19 at the Hospital “Dr. Luis Diaz Soto”.

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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.

Acronym of Public Title:

VALENTIA

Scientific title:

Retrospective study of the administration of Jusvinza according to the CUBA action protocol, for the management of COVID-19 at the Hospital "Dr. Luis Diaz Soto". (COVID-19)

Acronym of Scientific Title:

VALENTIA

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB)

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:

Leticia

Midle name:

del Rosario

Last name:

Cruz

Medical Specialty :

Second degree specialist in Intensive Medicine

Affiliation:

"Luis Diaz Soto" Hospital

Postal address:

Ave Monumental Km 2 ½

City:

Havana

Country:

Cuba

Zip Code:

19130

Telephone:

+53-77680715

Email address:

lrosarioc@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:

Complete

Date of first enrollment:

20/03/2021

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:

Systemic inflammation by Covid-19

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Severe Acute Respiratory Syndrome

Respiratory Tract Diseases

Health condition keyword:

COVID-19

SARS-CoV-2

Intervention(s):

- Therapeutic scheme with Jusvinza for patients with mechanical ventilation: 2 mg every 12 hours intravenously until the patient is extubated. After this, the treatment corresponding to that day is completed. Subsequently, 1 mg daily intravenously for 3 days. The patient who starts treatment with CIGB-258 (Jusvinza) is withdrawn from interferon treatment. - Therapeutic scheme with Jusvinza for critically ill patients without mechanical ventilation: 1 mg every 12 hours intravenously until the patient reverses her condition, interpreted as that the patient does not require oxygen therapy, nor does he show signs or symptoms of acute respiratory failure. - Therapeutic scheme with Jusvinza for High Risk patients: 1 mg every 12 hours intravenously until the patient reverts her condition, interpreted as that the patient improves the signs of Pneumonia; and decrease the neutrophil / lymphocyte ratio below 3. Irrespective of their clinical condition, obese patients received 2 mg every 12 hours.

Intervention code:

Peptides

Administration, Intravenous

Intervention keyword:

Jusvinza

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. Percentage of high risk patients recovered. Measurement time: 7 days after treatment 2. Percentage of seriously ill patients recovered. Measurement time: 10 days after treatment 3. Percentage of critically ill patients recovered. Measurement time: 15 days after treatment

Key secondary outcomes:

1. Clinical evolution (Vital signs: mean arterial pressure (mmHg), heart rate (beats/min), respiratory rate (breaths/min) and body temperature (⁰C); Ventilatory parameters: SO2 (%), PaO2 (mmHg) and PF). Measurement time: from the onset of symptoms to medical discharge. 2. Radiological evolution (According to the RALE score (0 to 8 points)). Measurement time: from admission to discharge. 3. Serum inflammatory biomarkers (Values of NLR, C-reactive protein, erythrocyte sedimentation, Ferritin, LDH, D-dimer, CPK, ASAT, ALAT). Measurement time: at time 0, 96 hours after starting treatment with Jusvinza and at medical discharge. 4. Cytokines (Values of IL-6, TNFα and IL-10). Measurement time: at time 0, 96 hours after starting treatment with Jusvinza and at medical discharge. 5. Percentage of CD4, CD8 and Treg lymphocytes. Measurement time: at time 0, 96 hours after starting treatment with Jusvinza and at medical discharge. 6. Adverse Events-AE (Percentage of Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (Grade 1: mild, Grade 2: moderate, Grade 3: grave, Grade 4: grave, Grade 5: grave), -Causality relationship (Definite, Probable, Possible, Doubtful). -Measures have (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Interruption of the treatment under study, Extension of hospitalization), -Result (Fully resolved, Resolved with aftermath, Improved, Overrun, Worsening, Death caused by this event)). Measurement time: from the beginning of the treatment until to medical discharge.

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. Patients older than 19 years. 2. SARS-CoV-2 positive patients in moderate, severe or critical conditions, who have been indicated for treatment with Jusvinza, in the period between March 20 and September 6, 2021.

Exclusion criteria:

Not applicable

Type of population:

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:

N/A

Target sample size:

348

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:

Maria

Middle Name:

del Carmen

Last Name:

Dominguez Horta

Specialty:

Degree in Biochemistry; Doctor in Biological Sciences.

Affiliation:

Center for Genetic Engineering and Biotechnology (CGIB)

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

mcarmen.dominguez@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:

Maria

Middle Name:

del Carmen

Last Name:

Dominguez Horta

Specialty:

Degree in Biochemistry, Doctor in Biological Sciences.

Affiliation:

Center for Genetic Engineering and Biotechnology (CGIB)

Postal Address:

Ave. 31 e/ 158 y 190, Cubanacan, Playa

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+53-72716022

Email :

mcarmen.dominguez@cigb.edu.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

"Luis Diaz Soto" Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

15/06/2021

Postal address of Ethic Committee :

Av. Monumental 2 1/2,Habana del Este, Havana, ZC:19130, Cuba

Telephone:

+53-7680000

Email:

idelsisem@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

348

Study completion date:

31/10/2021

Date of available results:

30/11/2021

Date of first publication:

31/01/2022

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:

RPCEC00000394

Date of Registration in Primary Registry:

29/10/2021

Record Verification Date:

2021/10/29

Next update date:

2022/10/29

Link to the spanish version:

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Registered Trials

Registration process

Retrospective observational study of the administration of Jusvinza, for the management of COVID-19 at the Hospital “Dr. Luis Diaz Soto”.

About the RPCEC

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