Revisions for Anti SARS-CoV-2 gammaglobulin | Registro Público Cubano de Ensayos Clínicos

--- 30 June 2021 - 2:30pm by Gladys
+++ 14 September 2021 - 12:21pm by AICA
-/06/30
+/07/07
-/06/30
+/07/07

Revision of 14 September 2021 - 12:21pm:

Anti SARS-CoV-2 gammaglobulin

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:

GammaCOVID-AICA

Scientific title:

Exploratory, controlled, randomized, open and monocentric clinical trial to evaluate the safety and explore the antiviral effect of anti-SARSCoV-2 gamma globulin in Sars-Cov-2 adult serious with COVID-19.

Acronym of Scientific Title:

GammaCOVID-AICA

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

AICA Laboratorories Company (AICA)/Ministry of Public Health (MINSAP)

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:

Beatriz

Last name:

Amat Valdes

Medical Specialty :

Integral General Medicine, First Degree in Immunology, Titular professor.

Affiliation:

Military Hospital Dr. Luis Diaz Soto

Postal address:

Monumental Avenue and Carretera del Asilo, Habana del Este

City:

Havana

Country:

Cuba

Zip Code:

10900

Telephone:

+53-77680030

+53-53882317

Email address:

bsuatv@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:

Pending

Date of first enrollment:

01/07/2021

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:

COVID-19

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Health condition keyword:

COVID-19

SARS-CoV2

Intervention(s):

Group A (Control): Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab), for seriously patients. Group B (Experimental): Anti-SARS-COV-2 gammaglobulin + Cuban national action protocol for Covid-19. Version 1.6. (Except itolizumab), for seriously patients. This group will receive the investigation product Anti-SARS-COV-2 gammaglobulin, a single dose of 150 mg/kg (1100 IU/Kg) diluted in 300 mL of 0.9 % saline solution (total volume), slow drip initially (20 drops/min) and after 15 min, move to a faster drip, infusing the product in a period of no less than 2 hours, (intravenous route).

Intervention code:

gamma-Globulins

Immunoglobulins

Infusions, Intravenous

Intervention keyword:

Anti-SARS-COV-2 gamma globulin

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):

Safety: 1. Serious adverse events. Causation relationship (1. Possible, 2. Probable, 3. Definitive). Measurement time: 7 days after treatment. Exploring the Effect: 2. Antiviral and anti-inflammatory favorable response on the 7th day after the treatment The favorable response is measured if there is an increase in the Ct value, in the RT PCR and a decrease in the neutrophil/lymphocyte ratio; of C-reactive protein and D-Dimer). Measurement time: days 0, 3, 5 and 7 after treatment.

Key secondary outcomes:

Of safety: 1. Clinical Adverse Events-AE (- Type of AE (Serious or Not serious), - Duration of the AE (Difference, in dates, between the start and end of the AE), - AE Intensity (Mild, Moderate, Severe), - Behavior regarding the treatment under study (No changes, Interruption of the treatment under study), - AE result (Recovered, Improved, Persists, Sequelae). Measurement time: 7 days after treatment administration. 2. Percentage of patients with out-of-range values in clinical laboratory variables (hemochemistry).Measurement time: Days 0, 3, 5 and 7. Of antiviral effect. 3. PCR RT (Qualitative: positive or not, and value of CTs (cycle threshold)). Measurement time: Days 0, 3, 5 and 7. Inflammatory immune response. 4. Neutrophil / lymphocyte ratio (NLR) (The values at each time and the absolute change of the final value with respect to the initial value will be described). Measurement time: Days 0, 3, 5 and 7. 5. Quantitative C-Reactive Protein (The values at each time and the absolute change of the final value with respect to the initial value will be described. It will be recorded if there was a decrease in the values on day 7 with respect to the baseline value). Measurement time: Days 0, 3, 5 and 7. 6. D-dimer (The values at each time and the absolute change of the final value with respect to the initial value will be described. It will be recorded if there was a decrease on day 7 with respect to the baseline value). Measurement time: Days 0, 3, 5 and 7. Clinical response: 7. Imaging changes of the CT scan (Favorable: When there is a decrease in SCORE and there are no qualitative complications, whether or not it has. Stationary: When the same conditions are maintained in both variables. Unfavorable: When the SCORE is increased and / or there are qualitative complications). Measurement time: Days 0, 7. 8. Lung X-ray changes (The score on the diagnostic scale will be categorized into normal (0), mild (1-2), moderate (3-6) and severe (> 6).). Measurement time: Days 0, 3, 5 and 7. 9. Improvement of severity criteria (It will be recorded whether or not each one of the severity parameters considered is present: (SpO2 <93%, need for oxygen therapy to maintain SO2> 93%, PaO2 / FiO2 ratio <250 mm Hg, Respiratory rate ≥ 25 inspirations / min, Infiltrates in more than 50% of both lung fields). Each day will be considered if there was improvement to the favorable change in each of them. The evolution of the improvement will be evaluated at each moment with respect to the initial moment). Measurement time: Daily 10. Worsening of the patient's clinical condition (The following variables will be recorded as yes or no to the patient's condition: Need for ventilation during the study period, Increase in RF, decrease in oxygen saturation, worsening of chest X-ray images, shock, disseminated intravascular coagulation, multi-organ failure, death. It is defined as a worsening of the clinical state of the patient if at least one of these described conditions occurs, at some point after the treatment under study.). Measurement time: Daily 11. Need for mechanical ventilation (It Will recorded if patient’s needs, or no, mechanical ventilation). Measurement time: Daily 12. Duration of mechanical ventilation (the start and end date of assisted ventilation will be recorded). Measurement time: at the end of mechanical ventilation 13. Stay in the ICU (the date of admission and discharge from the ICU will be recorded). Measurement time: at the ICU discharge 14. Hospital stay (The date of admission and discharge from the hospital will be recorded). Measurement time: at the hospital 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:

75 years

Inclusion criteria:

1. Severe patients aged between 19 and 75 years, with a confirmed diagnosis by RT-PCR of infection by the SARS-CoV-2 virus. 2. Patients with less than 10 days of evolution since the onset of symptoms. 3. Patient who gives his informed consent.

Exclusion criteria:

1. Ventilated 2. With acute and chronic kidney disease 3. Previous thromboembolic events 4. History of previous anaphylaxis 5. Previous history of adverse reaction to intravenous gamma globulin 6. Pregnant or lactating woman 7. Severe comorbidity: terminal cancer and severe heart disease. 8. Body Mass Index (BMI) ≥ 30 9. With a diagnosis of selective IgA immunodeficiency 10. With autoimmune diseases 11. That they are using treatment with the anti-CD 6 monoclonal antibody Itolizumab 12. History of having received treatment with blood products one month before inclusion in the study.

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:

1

Target sample size:

30

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:

Beatriz

Last Name:

Amat Valdés

Specialty:

Integral general Medicine First degree in immunology

Affiliation:

Military Hospital Dr. Luis Diaz Soto

Postal Address:

Avenida Monumental y Carretera del Asilo, Habana del Este

City:

Havana

Country:

Cuba

Zip Code:

10900

Telephone:

+53-77680030 +53-53882317

Email :

bsuatv@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:

Consuelo

Last Name:

Macias Abraham

Specialty:

Specialist in 2nd degree in Immunology. Professor and Titular researcher.

Affiliation:

Institute of Hematology and Immunology Dr. Jose Manuel Ballester Santovenia

Postal Address:

Street 19 between 8 and 10, Vedado, Plaza de la Revolucion

City:

Havana

Country:

Cuba

Zip Code:

10400

Telephone:

+53-52680285

Email :

cmabraham@infomed.sld.cu

Research Ethics Committees

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

Name of Research Ethics Committees:

Military Hospital “Dr. Luis Diaz Soto”

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

24/05/2021

Postal address of Ethic Committee :

Avenue Monumental and Carretera del Asilo, Habana del Este, Havana, Cuba

Telephone:

+53-77680030

Email:

bsuatv@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Study completion date:

07/10/2021

Date of available results:

30/12/2021

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:

RPCEC00000379

Date of Registration in Primary Registry:

30/06/2021

Record Verification Date:

2021/07/07

Next update date:

2022/07/07

Link to the spanish version:

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Registered Trials

Registration process

Anti SARS-CoV-2 gammaglobulin

About the RPCEC

Useful resources