PLASMA TREATMENT TO ASYMPTOMATIC PATIENT WITH COVID-19 INFECTION

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:

TRANSFUSION WITH CONVALING PLASMA IMMUNIZES THE ASYMPTOMATIC PATIENT WITH COVID INFECTION 19 THAT FOR MORE THAN 30 DAYS IS POSITIVE SARS CoV-2 PCR (COVID-19)

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

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:

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:

Consuelo

Last name:

Macias Abraham

Medical Specialty :

Specialist 2nd Degree in Immunology

Affiliation:

Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”

Postal address:

Eighth Street No. 460, between 17 and 19, Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78465555

+53-78465554

Email address:

cmabraham@infomed.sld.cu [1]

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:

Recruiting

Date of first enrollment:

05/05/2020

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 infection

Health condition(s) code:

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Severe Acute Respiratory Syndrome

Health condition keyword:

COVID-19

Intervention(s):

Administration of one to four bags (300 ml) of plasma by intravenous route the days 1, 3, 7 and 12.

Intervention code:

Plasma

Administration, Intravenous

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. Improvement of the respiratory failure (It will measure as an increase in the partial pressure of oxygen above 60 mmHg or oxygen saturation greater than 90.7%). Measurement time: 48 hours after treatment 2. Clinical improvement (It will measure through the change in the classification from Severe to From Care and From Care to Open Room). Measurement time: 72 hours after treatment 3. Improvement of at least two complete blood count parameters (It will measure as any positive difference in Hemoglobin levels, differential white blood cell count and platelet value). Measurement time: 48 and, 72 hours after treatment 4. Negativization of the PCR (Yes, No). Measurement time: 7 days after the treatment

Key secondary outcomes:

Adverse Events-AE (Occurrence of any AE in the subject (Yes, No), Type of AE (Name of the adverse event), Location (Local, Systemic), Time of onset (Immediate, Late), Duration of AE (Less than a day, Greater than a day), Previous knowledge (Expected, Unexpected), AEs intensity (Mild, Moderate, Severe), AEs severity (Serious, Not serious), AEs result (Recovered, Improved, Persists, Sequelae), Causal relationship (Very Probable, Probable, Possible, Unlikely, Not related, Not evaluable), Outcome of the AE (Recovered, Not Recovered, Recovered with sequelae, Death, Unknown), Attitude towards treatment of study (Continuation, Definitive interruption). Measurement time: At the end of treatment

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:

74 years

Inclusion criteria:

1. Adult with SARS-CoV2 infection diagnosed by RT-PCR. 2. Remain asymptomatic with SARS-CoV2 positive PCR for more than 30 days. 3. That the antibody kit tests do not detect antibodies. 4. That there is no history of anaphylaxis reactions with blood products. 5. That at the clinical evaluation by the attending physician there are no contraindications for plasma transfusion. 6. That the patient or their relatives give their informed consent to receive this donation.

Exclusion criteria:

None

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:

All patients who meet the criteria until September 30, 2020

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:

Consuelo

Last Name:

Macias Abraham

Specialty:

Specialist 2nd Degree in Immunology

Affiliation:

Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”

Postal Address:

Eighth Street No. 460, between 17 and 19, Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78465555, +53-78465554

Email :

cmabraham@infomed.sld.cu [1]

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 2nd Degree in Immunology

Affiliation:

Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”

Postal Address:

Eighth Street No. 460, between 17 and 19, Vedado, Revolution Square

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78465555, +53-78465554

Email :

cmabraham@infomed.sld.cu [1]

Research Ethics Committees

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

Name of Research Ethics Committees:

Institute of Hematology and Immunology “Dr. Jose Manuel Ballester Santovenia”

Status of evaluation:

Approved

Status of evaluation date of Ethic Committee:

30/04/2020

Postal address of Ethic Committee :

Eighth Street No. 460, between 17 and 19, Vedado, Revolution Square, ZP: 10400, Havana, Cuba

Telephone:

+53-78461106

Correo electrónico:

ensayosihi@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

12/10/2020

Date of available results:

12/12/2020

Date of first publication:

12/03/2021

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:

RPCEC00000323

Date of Registration in Primary Registry:

03/07/2020

Record Verification Date:

2020/08/19

Next update date:

2021/08/19

Link to the spanish version:

Click here [2]