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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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29 October 2021 - 1:16pm
by Gladys
1 November 2021 - 9:58am
by lazara
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Revision of 1 November 2021 - 9:58am:
Retrospective observational study of the administration of Jusvinza, for the management of COVID-19 at the Hospital “Dr. Luis Diaz Soto”.
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
Primary sponsor:
Center for Genetic Engineering and Biotechnology (CIGB)
Secondary sponsor:
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
Data Sharing
Section to complete the data related to the data sharing plan.
Data sharing plan:
No
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:
2021/11/01
Next update date:
2022/11/01
Link to the spanish version:
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