Safety in Convalescent Plasma Transfusion to COVID-19

Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection

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.

Study Overview

• Status: Terminated
• Conditions: COVID-19
• Intervention / Treatment: Biological: Convalescent Plasma

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: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Nuevo Leon
    • Monterrey, Nuevo Leon, Mexico, 64718
      • Hospital San José

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Supportive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects	Identify possible adverse effects after the administration of convalescent plasma	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Failure	Development of heart failure during convalescent plasma transfusion or after it.	14 days
Pulmonary Edema	Development of pulmonary edema during convalescent plasma transfusion or after it.	14 days
Allergic Reaction	Development of any allergic reaction during convalescent plasma transfusion or after it.	14 days
Viral load of SARS-CoV-2	RT PCR SARS-CoV-2	48 hrs
Viral load of SARS-CoV-2	RT PCR SARS-CoV-2	14 days

Collaborators and Investigators

• Sponsor: Hospital San Jose Tec de Monterrey
• Collaborators: Tecnologico de Monterrey
• Investigators: Principal Investigator: José Fe Castilleja-Leal, MD., Hospital San José

Publications and helpful links

General 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. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 8, 2020
• Primary Completion (ACTUAL): August 20, 2020
• Study Completion (ACTUAL): August 20, 2020

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (ACTUAL): April 3, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: SARS-CoV-2; COVID-19; Convalescent plasma
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: PC-TecSalud Fase I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No