Clinical trial NCT04333355: Safety in Convalescent Plasma Transfusion to COVID-19
Official title: Phase 1 Study to Evaluate the Safety of Convalescent Plasma as an Adjuvant Therapy in Patients With SARS-CoV-2 Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: COVID-19
Keywords: COVID-19
SARS-CoV-2
Convalescent plasma
Lead sponsor: TecSalud Investigación Clínica
Sponsor class: OTHER
Collaborators: name: Tecnologico de Monterrey
First posted: 2020-04-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Side effects
timeFrame: 14 days
Secondary outcomes:
measure: Heart Failure
timeFrame: 14 days
measure: Pulmonary Edema
timeFrame: 14 days
measure: Allergic Reaction
timeFrame: 14 days
measure: Viral load of SARS-CoV-2
timeFrame: 48 hrs
measure: Viral load of SARS-CoV-2
timeFrame: 14 days
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital San José
state: Nuevo Leon
Study officials:
affiliation: Hospital San José
name: José Fe Castilleja-Leal, MD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.