Stem cells in patients with lung lesions (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:

Treatment of lung lesions with autologous stem cells in patients recovered from COVID-19 (COVID-19)

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Cuban Ministry of Public Health

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

Country:

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:

Lung lesions

Health condition(s) code:

Lung Injury

Lung Diseases

Respiratory Tract Diseases

Thoracic Injuries

Coronavirus Infections

SARS Virus

Coronaviridae Infections

Betacoronavirus

Severe Acute Respiratory Syndrome

Health condition keyword:

COVID-19

Intervention(s):

Experimental Group: Mobilization of stem cells with the intramuscular administration of IOR® LEUKOCIM in 4 doses of 10 µg / kg of weight every 12 hours for 2 days as a strategy to stimulate the hematopoietic system of the patient. With a view to obtaining 400 ml of blood, cell separation and intravenous infusion of 200 x 106 mononuclear cells or more containing at least 1% CD34 + progenitor cells in a single dose. Control Group: Prednisone at a dose of 0.75-1 mg / kg / day, not exceeding a total single dose of 60mg / day during a period of 2 weeks, oral administration

Intervention code:

Hematopoietic Stem Cell Mobilization

Prednisone

Injections, Intramuscular

Administration, Oral

Intervention keyword:

IOR® LEUKOCIM

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):

Reduction of the lung lesions (They will evaluate by images of the Chest Computed Tomography. In which it is measured through a lung damage assessment scale consisting of: a. No injury (0 points), b. Unilateral lesion with less than three lesions of any type or without expression of lesions in all lung lobes a + b (1 point), c. Unilateral lesion with more than three injuries of any type or involvement of all the lung lobes (2 points), d. Bilateral lung lesions b + b (2 points) b + c (4 points) and c + c (6 points), e. Add one more point if there are lesions in all the lobes between both lungs and f. Add an additional point if there is lung consolidation (bacterial pneumonia or clothing), lymphadenopathy or pleural effusion. The value is between 0 (normal) and 8 (maximum possible involvement). The scale will allow quantifying in percentage the results of the improvement or not of the lung lesions, classifying them as improvement, stabilization or worsening). Measurement time: at baseline and, a month and six months after treatment.

Key secondary outcomes:

1. Differences in forced vital capacity measured through the FEV1/FVC (It is expressed as the Increase of more than 10% of FVC by Spirometry according to the ATS / ERS 2019 update). Measurement time: at baseline and, a month and six months after treatment. 2. Differences in forced expiratory volume to the second-FEV1 (It will evaluate through a spirometer which measures the milliliters of expiration in one second and is expressed in hundreds. Measurement time: at baseline and, a month and six months after treatment. 3. Differences in the 6-minute walk test-6MWD (It will measure in meters walked in 6 minutes. Which according to the values predicted on the Borg scale give a classification of excessively light, very light, light, neither light nor heavy, heavy, very heavy and excessively heavy). Measurement time: at baseline and, a month and six months after treatment. 4. Quality of life (It will evaluate by the SF-36 questionnaire which evaluates 9 items, to which a score is given and based on the total points is classified as excellent, Very good, good, fair and poor. Decreased degree of dyspnea or cough a degree on the Medical Research Council (mMRC) modified dyspnea rating scale measured in degrees such as: (0) Dyspnea occurs only with great physical exertion, (1) Dyspnea occurs when walking fast on a flat surface or when climbing a shallow slope, (2) Dyspnea makes it impossible to keep up with other people of the same age walking on a flat surface, or forces you to stop or rest when walking on a flat surface at your own pace, (3) Has to stop to rest when walking ~ 100 m or more after a few minutes of walking on the flat and (4) Dyspnea prevents the patient from leaving home or appears with activities such as dressing or undressing). Measurement time: at baseline and, a month and six months after treatment. 5. Adverse Events-AE (- Occurrence of some AE in the subject (yes / no), - Description of the AE (Name of the adverse event), - Duration of the AE (Difference of dates between the start and the end of the event), - time of presentation of the AE (Immediate, Medium, Late), - Severity of the AE (Serious / serious, Not serious / not serious), -Relation of causality (Very Probable, Probable, Possible, Unlikely, Not related, Not evaluable)). Measurement time: at baseline and, a month and six months after 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. Patient who gives his informed consent. 2. Negative viral load by PCR. 3. Over 18 and under 75. 4. Lung damage evidenced by the criteria of radiological severity in COVID 19 on CT.

Exclusion criteria:

1. Anemia 2. Patients with contraindications to the use of IOR® LEUKOCIM. 3. Patients who have taken amiodarone in the last 3 months, which can cause pulmonary fibrosis. 4. Patients with malignant tumor in the last 5 years. 5. Patients with decompensated heart and kidney disease. 6. Patients with liver disease whose presence of enzyme values 2 times above the upper level of the range of normal values is demonstrated in the blood chemistry. 7. Patients who have ultrasound images that require further study for diagnosis. 8. Pregnant women 9. Patients with severe lung infection who need anti-infective treatment. 10. Patients with proven viral infections or positive serology.

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:

N/A

Target sample size:

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

Country:

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

Country:

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

Email:

ensayosihi@infomed.sld.cu

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

Study completion date:

15/12/2020

Date of available results:

15/02/2021

Date of first publication:

12/05/2021

Results Study

Section to complete the data related to the summarized results.

Url for Results File:

Not applicable

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:

RPCEC00000322

Date of Registration in Primary Registry:

03/07/2020

Record Verification Date:

2020/09/14

Next update date:

2021/09/14

Link to the spanish version:

Click here [2]