Revisions for CIGB-258 at COVID-19 | Registro Público Cubano de Ensayos Clínicos

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Revision of 29 May 2020 - 8:55pm:

CIGB-258 at 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:

Administration of the CIGB-258 peptide in patients with COVID-19 under intensive therapy regimen (COVID-19)

Secondary indentifying numbers:

CIGB-258/2020

Issuing authority of the secondary identifying numbers:

Center for Genetic Engineering and Biotechnology (CIGB)

Source(s) of monetary or material support:

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

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 :

1st 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

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 Kourí" Tropical Medicine Institute, Daniel Gonzalez, Doctor of Medical Sciences.

Recruitment status

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

Recruitment status:

Complete

Date of first enrollment:

31/03/2020

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:

COVID-19 respiratory distress

Intervention(s):

Group CIGB-258 peptide: 1 mg intravenously every 12 hours until extubation, followed by the same dose every 24 hours for three days (in patients with mechanical ventilation, where the dose can be increased to 2 mg if at 72 hours, there is no clinical, blood gas, and radiological improvement) or 1 mg intravenously every 24 hours in patients without mechanical ventilation, until their condition reverts.

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):

Mortality on discharge from the ICU (Proportion of patients who die, according to their causes). Measurement time: during the stay in the Intensive Care Unit.

Key secondary outcomes:

1) Reduction of the deterioration of the lung function (Proportion of patients that did not require increasing FiO2 to maintain stable SO2 and without the need for intubation and / or Percentage of patients that decrease the values of positive pressure at the end of expiration (PEEP)). Measurement time: On the 7th day after starting the treatment. 2) Need and time for mechanical ventilation (Yes, No; time in days elapsed from the start date of ventilation until weaning). Measurement time: During the stay in intensive care, until ventilatory weaning. 3) Measurement of hyperinflammation score parameters (temperature, visceromegaly, cytopenia, triglycerides, aspartate aminotransferase - TGO, fibrinogen, ferritin). Measurement time: at the beginning, at hours 48 and 72, as well as on the 5th and 7th day after starting the treatment. 4) Stay in intensive care-ICU (Time in the ICU from the start of treatment until discharge). Measurement time: during ICU stay. 5) Immunological response (Determination of serum concentrations of IL-1, IL-6, IL-17 and TNF alpha). Measurement time: at the beginning, at hours 48 and 72, as well as on the 5th and 7th day after starting the treatment. 6) Behavior of prognostic biomarkers (Absolute lymphocyte count, C-reactive protein, erythrocyte sedimentation rate, lactate dehydrogenase - LDH and D-dimer). Measurement time: at baseline, at hours 48 and 72, at the 5th and 7th day. 7) Clinical Adverse Events-AE (They will be measured as: -AE occurrence (Yes, No), -AE description (event name), -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 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) Virological diagnosis by PCR-RT of infection to SARS-CoV-2. 2) Patients with confirmed respiratory distress / multifocal interstitial pneumonia. 3) Need for oxygen therapy to maintain SO2> 93%. 4) Worsening of lung involvement, defined as one of the following criteria: a) Worsening of oxygen saturation> 3 percentage points or decrease in PaO2> 10%, with stable FiO2 in the last 24 hours; b) Need to increase FiO2 in order to maintain stable SO2 or new need for mechanical ventilation in the last 24 hours; c) Increase in the number and / or extension of the lung consolidation areas. 5) Express voluntariness of the patient, family member or impartial witness.

Exclusion criteria:

- Pregnancy or lactation.

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:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

N/A

Target sample size:

16

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:

Graduated in Biochemistry; PhD in Biological Sciences.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 158 y 190, Cubanacan, Playa.

City:

Havana

Country:

Cuba

Zip Code:

11300

Telephone:

+537-2716022

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:

Graduated in Biochemistry; PhD in Biological Sciences.

Affiliation:

Center for Genetic Engineering and Biotechnology (CIGB).

Postal Address:

Ave. 31 entre 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

"Pedro Kouri" Tropical Medicine Institute

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/03/2020

Postal address of Ethic Committee :

Ave Monumental Km 2 ½, Habana del Este, La Habana, C.P:19130, Cuba

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

Telephone:

+53-77680715

+53-72020425

Email:

-

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

16

Study completion date:

30/04/2020

Date of available results:

30/05/2020

Date of first publication:

30/06/2020

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:

RPCEC00000313

Date of Registration in Primary Registry:

14/05/2020

Record Verification Date:

2020/05/14

Next update date:

2021/05/14

Link to the spanish version:

Click here

Registered Trials

Registration process

CIGB-258 at COVID-19

About the RPCEC

Useful resources