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Safety in Convalescent Plasma Transfusion to COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04333355
Recruitment Status : Recruiting
First Posted : April 3, 2020
Last Update Posted : May 8, 2020
Sponsor:
Collaborator:
Tecnologico de Monterrey
Information provided by (Responsible Party):
Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey

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.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: Convalescent Plasma Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
Estimated Study Start Date : May 25, 2020
Estimated Primary Completion Date : December 20, 2020
Estimated Study Completion Date : April 30, 2021

Arm Intervention/treatment
Experimental: COVID-19 patients receiving Convalescent Plasma
Convalescent Plasma from patients who recently recover from COVID-19
Biological: Convalescent Plasma
Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.
Other Name: Supportive standard care




Primary Outcome Measures :
  1. Side effects [ Time Frame: 14 days ]
    Identify possible adverse effects after the administration of convalescent plasma


Secondary Outcome Measures :
  1. Heart Failure [ Time Frame: 14 days ]
    Development of heart failure during convalescent plasma transfusion or after it.

  2. Pulmonary Edema [ Time Frame: 14 days ]
    Development of pulmonary edema during convalescent plasma transfusion or after it.

  3. Allergic Reaction [ Time Frame: 14 days ]
    Development of any allergic reaction during convalescent plasma transfusion or after it.

  4. Viral load of SARS-CoV-2 [ Time Frame: 48 hrs ]
    RT PCR SARS-CoV-2

  5. Viral load of SARS-CoV-2 [ Time Frame: 14 days ]
    RT PCR SARS-CoV-2



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04333355


Contacts
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Contact: Servando Cardona-Huerta, MD., Ph. D. +5218112121946 servandocardona@tec.mx
Contact: Sylvia De la Rosa, MD +5218111832730 sylvia.delarosa@tec.mx

Locations
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Mexico
Hospital San José Recruiting
Monterrey, Nuevo Leon, Mexico, 64718
Contact: Servando Cardona-Huerta, MD, PhD    +5218112121946    servandocardona@tec.mx   
Contact: Sylvia de la Rosa-Pacheco, MD    +5218111832730    sylvia.delarosa@tec.mx   
Principal Investigator: José Fe Castilleja-Leal, MD         
Sponsors and Collaborators
Hospital San Jose Tec de Monterrey
Tecnologico de Monterrey
Investigators
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Principal Investigator: José Fe Castilleja-Leal, MD. Hospital San José
Publications:
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Responsible Party: Servando Cardona-Huerta, Director of Clinical Research, Hospital San Jose Tec de Monterrey
ClinicalTrials.gov Identifier: NCT04333355    
Other Study ID Numbers: PC-TecSalud Fase I
First Posted: April 3, 2020    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey:
COVID-19
SARS-CoV-2
Convalescent plasma