This is a double-blinded, randomized control trial to assess the efficacy and safety of anti-SARS-CoV-2 convalescent plasma as early treatment. Participants will be randomized 2:1 to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody ("anti-SARS-CoV-2 plasma") or control (albumin 5%). This study will investigate the potential of convalescent plasma (CP) to reduce severity of and/or help treat SARS-CoV-2 disease in patients with mild disease.
There are no approved therapies for Coronavirus disease 2019 (COVID-19), also known as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Exposure to viruses results in an adaptive immune response that commonly include antibodies with neutralization activity. Plasma from subjects who have recovered from viral infections has been used to both prevent or treat disease. Notable examples of the successful use of convalescent plasma (CP) include influenza, measles, Argentine hemorrhagic fever, Middle East respiratory syndrome (MERS), Ebola and severe acute respiratory syndrome (SARS). In recent work in China, an open label safety trial of CP in patients with COVID-19 suggested a substantive benefit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
223
Convalescent Plasma that contains antibody titers against SARS-CoV-2.
Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.
National Institute of Infectious Diseases Evandro Chagas (INI)
Rio de Janeiro, Brazil
Number of Non-Hospitalized Participants
Participants who were discharged from the hospital after receiving the study intervention.
Time frame: Up to 28 days
Number of Hospitalized Participants Requiring Supplemental Oxygen
Participants who remained hospitalized and required supplemental oxygen after receiving the study drug.
Time frame: Up to 28 days
Number of Hospitalized Participants Requiring High-flow Oxygen Therapy or Noninvasive Mechanical Ventilation
Participants who remained hospitalized and required high-flow oxygen therapy or noninvasive mechanical ventilation after receiving the study intervention.
Time frame: Up to 28 days
Number of In-hospital Mortalities
Participants who died in the hospital after receiving the study drug.
Time frame: Up to 28 days
Rate of Measurable Anti-SARS-CoV-2 Titers
To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).
Time frame: Up to 90 days
Rate of SARS-CoV-2 PCR Positivity
Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
Time frame: Up to 28 days
Duration of SARS-CoV-2 PCR Positivity
Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
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Time frame: Up to 28 days
Levels of SARS-CoV-2 RNA
Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)
Time frame: Up to 28 days