Safety in Convalescent Plasma Transfusion to COVID-19

NCT ID: NCT04333355

Last Updated: 2021-02-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2020-08-20

Brief Summary

There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma. The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. This plasma will be infused in patients affected by the same virus, but who have developed respiratory complications that have not responded favorably to usual treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Detailed Description

There is currently no specific vaccine or treatment to treat critically ill patients with COVID-19. Different therapies are still under investigation and are use in different health institutions, however, a significant proportion of patients do not respond to these treatments, so it is important to seek new treatments. One of these alternatives is the use of convalescent plasma.

The investigator will use plasma obtained from convalescent individuals with proven novel SARS-CoV-2 virus infection, diagnosed with coronavirus-19-induced disease and symptom-free for a period of not less than 10 days since they recovered from the disease. Donors will be screened for infectious diseases including sARS-CoV-2 and will be programmed for apheresis the next day. The investigaotr will process one plasmatic volume per donor and this will be guarded in the blood bank until required by the principal investigator.

Patients or receptors will be screened and selected by the research team according to eligibility criteria, including severe disease refractory to treatment such as chloroquine, hydroxychloroquine, azithromycin, and other antivirals. Plasma will be fractioned in 250ml. Infusion will start after a clinical evaluation and blood sampling. Patients will remain under careful observation. If no adverse event is present, infusion will be repeated after 24 hours and the investigator will evaluate patients again 48 hours after the second transfusion. A final evaluation will be performed at day 14. The investigator will evaluate the safety of this procedure by accounting for any adverse event.

Conditions

COVID-19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COVID-19 patients receiving Convalescent Plasma

Convalescent Plasma from patients who recently recover from COVID-19

Group Type: EXPERIMENTAL

Convalescent Plasma

Intervention Type: BIOLOGICAL

Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.

Interventions

Convalescent Plasma

Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.

Intervention Type: BIOLOGICAL

Other Intervention Names

Supportive standard care

Eligibility Criteria

Inclusion Criteria

1. Patients 18 years and older

2. Confirmed SARS-CoV-2 Infection by RT-PCR.

3. Serious or life-threatening infection defined as:

Serious:

1. Dyspnea

2. Respiratory rate greater than or equal to 30 cycles / minute.

3. Blood oxygen saturation less than or equal to 93% with an oxygen supply greater than 60%.

4. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300

5. A 50% increase in pulmonary infiltrates defined by computer tomography scans in 24 to 48 hours.

Life-threatening infection:

6. respiratory failure.

7. septic shock.

8. dysfunction or multiple organ failure.

4. Refractory to treatment with azithromycin / hydroxychloroquine or chloroquine / ritonavir / lopinavir defined as: 48 hours with no improvement in the modified parameters such as serious or clinically imminent infection.

5. Signed Informed consent by the patient or by the person responsible for the patient in the case of critically ill patients (spouse or parents).

Exclusion Criteria

1. Patients with a history of allergic reaction to any type of previous transfusion.

2. Heart failure patients at risk of volume overload.

3. Patients with a history of chronic kidney failure in the dialysis phase.

4. Patients with previous hematological diseases (anemia less than 10 grams of hemoglobin, platelets greater than 100,000 / µl).

5. Any case where the investigator decides that the patient is not suitable for the protocol.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tecnologico de Monterrey

OTHER

Sponsor Role: collaborator

TecSalud Investigación Clínica

OTHER

Sponsor Role: lead

Responsible Party

Servando Cardona-Huerta

Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Fe Castilleja-Leal, MD.

Role: PRINCIPAL_INVESTIGATOR

Hospital San José

Locations

Hospital San José

Monterrey, Nuevo León, Mexico

Countries

Mexico

References

Casadevall A, Pirofski LA. The convalescent sera option for containing COVID-19. J Clin Invest. 2020 Apr 1;130(4):1545-1548. doi: 10.1172/JCI138003. No abstract available.

Reference Type: BACKGROUND

PMID: 32167489 (View on PubMed)

Other Identifiers

PC-TecSalud Fase I

Identifier Type: -

Identifier Source: org_study_id