Clinical trial NCT04528368: Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Official title: Efficacy and Safety of Using Convalescent Plasma for Treating Patients With COVID-19 Pneumonia Without Indication of Ventilatory Support
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: COVID-19
Keywords: Convalescent plasma
SARS-CoV-2
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
Collaborators: name: Hospital do Coracao
First posted: 2020-08-27
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The COVID-19 pandemic has been spreading continuously, and in Brazil, until August 18, 2020, there have been more than 3,359,000 cases with more than 108,536 deaths, with daily increases. The present study proposes to evaluate the efficacy and safety of using convalescent plasma for treating patients with COVID-19 pneumonia without indication of ventilatory support.


Eligibility criteria: Recipient Inclusion Criteria:

* Confirmed diagnosis of COVID-19 by RT-PCR;
* Time between symptom onset and inclusion ≤ 7 days;
* Chest tomography with \<50% involvement of the lung parenchyma;
* No indication of ventilatory support at the time of randomization;
* Sign the consent form.

Recipient Exclusion Criteria:

* Contraindication to transfusion or history of previous reactions to blood products for transfusion;
* Pregnant women;
* Limiting comorbidity for administering the therapies provided for in this protocol in the opinion of the investigator.

Donor Inclusion Criteria for Plasmapheresis:

* Convalescent plasma donation will be eligible for patients ≥ 18 years old who had previously confirmed COVID-19 by RT-PCR, which met the criteria adopted by technical notes n13 and 21/2020-CGSH/DAET/SAES/MS;
* SARS-COV-2 negative RT-PCR;
* Asymptomatic for at least 14 days;
* SARS-CoV-2 anti-peak titre with dilution ≥ 1: 320;
* Sign the consent form.

Donor Exclusion Criteria:

* Female gender with previous pregnancy;
* Absence of peripheral venous network compatible with the apheresis procedure;
* Positive or indeterminate result in any of the infectious screening tests;
* Presence of intellectual incapacity to understand the guidelines regarding the risks and benefits of participating in the study.

Primary outcomes:
measure: Area under the curve of SARS-COV-2 viral load obtained from nasopharyngeal and /or oropharyngeal swabs.
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
Secondary outcomes:
measure: Assessment of clinical improvement using an Ordinal Severity Scale
timeFrame: 0, 7, 10, 14, 21 and 28 days
measure: Evaluate oxygen saturation
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
measure: Evaluate oxygen supplementation
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
measure: Assess respiratory rate
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
measure: Evaluate the PaO2 / FiO2 ratio (for patients on mechanical mechanisms)
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
measure: Length of hospital stay
timeFrame: 21 days
measure: Length of stay in intensive care
timeFrame: 21 days
measure: Assess the rate of orotracheal intubation
timeFrame: 21 days
measure: Change in the profile of cytokines/chemokines in both groups
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
measure: Presence of antibodies against SARS-CoV-2 in serum after convalescent plasma administration
timeFrame: 0, 3, 6, 9, 12, 15, 18 and 21 days
measure: Death rate
timeFrame: 7, 10, 14, 21 and 28 days
measure: Rate of transfusion reactions to convalescent plasma infusion
timeFrame: 21 days
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: D'Or Institute for Research and Education
Study officials:
affiliation: D'Or Institute for Research and Education
name: Eduardo M Rego, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: