Revisions for VISION Study | Registro Público Cubano de Ensayos Clínicos

--- 26 October 2021 - 2:21pm by Gladys
+++ 1 November 2021 - 9:59am by lazara
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-/10/26
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Revision of 1 November 2021 - 9:59am:

VISION Study

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:

Evaluation of the effect and safety terapeutic of Jusvinza in severe patients with COVID-19

Secondary indentifying numbers:

IG/Jusvinza/CVD-19PG/2101

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB), Havana

Source(s) of monetary or material support:

Center for Genetic Engineering and Biotechnology (CIGB), Havana

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:

Rafael

Last name:

Venegas Rodriguez

Medical Specialty :

First 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:

rv@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, "Salvador Allende" Hospital, Tania Fernandez Sordo, MD. First degree specialist in Intensive Care.

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

30/10/2021

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:

Acute Respiratory Distress by Covid-19

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Severe Acute Respiratory Syndrome

Respiratory Tract Disease

Health condition keyword:

COVID-19

SARS-CoV-2

Intervention(s):

Standard therapy (Control group): Standard therapy. Jusvinza (Experimental group): Standard therapy + Jusvinza Standard therapy: Application of all the measures approved in the MINSAP protocol for the management of patients with Acute Respiratory Distress generated by COVID-19 Jusvinza: 1mg or 2mg by intravenous route up to the patient recover the status (how to not show the requiring of oxygen, and none sign or symptoms of acute respiratory failure). If during of treatment patients present impairing the clinical status or measuring related with laboratory parameters, the clinician could increase the dose each 2mg by intravenous route to 12 hours. The obesity patients will be receive 2 mg since initial of treatment.

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):

Progression to critical state (It will measured like Yes/No, established from the criticality state, and the main evaluation measure is based on the PO2 / Fi02 relationship). Measurement time: during the stay in the ICU.

Key secondary outcomes:

1. Mortality (Proportion of patients to die and their causes). Measurement time: during hospital stay. 2. Stay during serious condition (Time, in days, from inclusion in the trial to discharge from severe condition or progression to critical condition). Measurement time: At discharge from serious condition or progression to critical condition 3. Stay during critical condition (Time, in days, from the critical condition is established until the extubation or fatal outcome). Measurement time: At extubation moment or fatal outcome 4. Hospital stay (Time, in days, from hospital admission to discharge or fatal outcome). Measurement time: At hospital discharge or fatal outcome 5. Changes in the values of the biomarkers (Modification of the values in the absolute count of lymphocytes, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase – LDH). Measurement time: before time 0, 48 hours, 96 hours and, end of treatment. 6. Hyperinflammation and coagulopathy score parameters (Temperature, visceromegaly, cytopenias, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin, D-dimer). Measurement time: before time 0, 48 hours, 96 hours and, end of treatment. 7. Immune response in serum (It will measure through the determination of cytokines: IL-6, IL-10, IL-17, TNF, and INFγ, through commercial ELISAs). Measurement time: before time 0, 96 hours and, end of treatment. 8. Phenotype of T cells (It will measure through the determination of the TH1, TH17 and Treg phenotypes, through flow cytometry). Measurement time: before time 0 and, end of treatment. 9. Imaging response (The evolution of lung lesions will be evaluated by chest X-ray, TAC or pulmonary ultrasound). Measurement time: after starting treatment (and when clinically indicated). 10. Adverse Events-AE (They will be measured as: -Occurrence of AE (Yes, No), -Description of AE (name of event), -Intensity of AE (mild, moderate, severe), -Causality relationship (not related, doubtful , possible, probable, definitive), -Measures adopted (None, Administration of any pharmacological therapy, Addition of a non-pharmacological therapy, Study exit, Hospitalization / prolongation of hospitalization), -Result (Completely resolved, Resolved with sequelae, Conditions in improvement, Present and unchanged condition, Worsening, Death caused by this event)). Measurement time: daily during the entire period of admission to the ICU.

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. Age ≥ 19. 2. Virologial diagnosis by RT-PCR to SARS-Cov-2. 3. Patients with serious status. 4. Willingness of the patient through informed consent

Exclusion criteria:

1. Patients with kidney disease on hemodialysis. 2. Known hypersensitivity to any of the components of the formulations under study 3. Pregnancy or breastfeeding.

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 controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2

Target sample size:

108

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:

Julio

Middle Name:

Esmir

Last Name:

Baldomero Hernandez

Specialty:

Second degree specialist in Family Medicine, Master in Clinical Research

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

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

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+53-72087378

Email :

julio.baldomero@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; PhD in Biological Sciences

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB)

Postal Address:

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

City:

Havana

Country:

Cuba

Zip Code:

6162

Telephone:

+53-72716022 ext: 3221

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

"Salvador Allende" Hospital

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

13/09/2021

10/09/2021

Postal address of Ethic Committee :

Ave Monumental Km 2 ½, Habana del Este, Havana, ZC: 19130, Cuba

Calzada del Cerro, Cerro, Havana, ZC: 19210, Cuba

Telephone:

+53-77680715

Email:

rv@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

15/04/2022

Date of available results:

15/05/2022

Date of first publication:

15/07/2022

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:

RPCEC00000393

Date of Registration in Primary Registry:

26/10/2021

Record Verification Date:

2021/11/01

Next update date:

2022/11/01

Link to the spanish version:

Click here

Registered Trials

Registration process

VISION Study

About the RPCEC

Useful resources