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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 : July 28, 2020
Sponsor:
Collaborator:
Tecnologico de Monterrey
Information provided by (Responsible Party):
Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey

Tracking Information
First Submitted Date  ICMJE March 31, 2020
First Posted Date  ICMJE April 3, 2020
Last Update Posted Date July 28, 2020
Actual Study Start Date  ICMJE May 8, 2020
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
Side effects [ Time Frame: 14 days ]
Identify possible adverse effects after the administration of convalescent plasma
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2020)
  • Heart Failure [ Time Frame: 14 days ]
    Development of heart failure during convalescent plasma transfusion or after it.
  • Pulmonary Edema [ Time Frame: 14 days ]
    Development of pulmonary edema during convalescent plasma transfusion or after it.
  • Allergic Reaction [ Time Frame: 14 days ]
    Development of any allergic reaction during convalescent plasma transfusion or after it.
  • Viral load of SARS-CoV-2 [ Time Frame: 48 hrs ]
    RT PCR SARS-CoV-2
  • Viral load of SARS-CoV-2 [ Time Frame: 14 days ]
    RT PCR SARS-CoV-2
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2020)
  • Heart Failure [ Time Frame: 14 days ]
    Development of heart failure during convalescent plasma transfusion or after it.
  • Pulmonary Edema [ Time Frame: 14 days ]
    Development of pulmonary edema during convalescent plasma transfusion or after it.
  • Allergic Reaction [ Time Frame: 14 days ]
    Development of any allergic reaction during convalescent plasma transfusion or after it.
  • Lung infiltrates [ Time Frame: 48 hours ]
    Thorax Computer tomography
  • Lung infiltrates [ Time Frame: 14 days ]
    Thorax Computer tomography
  • Viral load of SARS-CoV-2 [ Time Frame: 48 hrs ]
    RT PCR SARS-CoV-2
  • Viral load of SARS-CoV-2 [ Time Frame: 14 days ]
    RT PCR SARS-CoV-2
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety in Convalescent Plasma Transfusion to COVID-19
Official Title  ICMJE Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: Convalescent Plasma
Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.
Other Name: Supportive standard care
Study Arms  ICMJE Experimental: COVID-19 patients receiving Convalescent Plasma
Convalescent Plasma from patients who recently recover from COVID-19
Intervention: Biological: Convalescent Plasma
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 1, 2020)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date December 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Servando Cardona-Huerta, MD., Ph. D. +5218112121946 servandocardona@tec.mx
Contact: Sylvia De la Rosa, MD +5218111832730 sylvia.delarosa@tec.mx
Listed Location Countries  ICMJE Mexico
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04333355
Other Study ID Numbers  ICMJE PC-TecSalud Fase I
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Servando Cardona-Huerta, Hospital San Jose Tec de Monterrey
Study Sponsor  ICMJE Hospital San Jose Tec de Monterrey
Collaborators  ICMJE Tecnologico de Monterrey
Investigators  ICMJE
Principal Investigator: José Fe Castilleja-Leal, MD. Hospital San José
PRS Account Hospital San Jose Tec de Monterrey
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP