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Study aim
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Regard to Coronavirus disease outbreak and lack of specific vaccine and drugs, designing of effective therapeutic strategies is major public health priorities. In this prospective, phase II trial, we are going to evaluate the safety and efficacy of plasma exchange with the equal volume of colloidal solution containing 4-5% albumin, fresh frozen plasma, and convalescent plasma in COVID-19 patients to reduce viral load and inflammatory molecules
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Design
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This is a prospective, phase 2 study that will be done on 10 patients with CoVID-19
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Settings and conduct
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This study will conduct on patients with COVID- 19 who admitted in the Taleghani hospital of Tehran. Approximately 1500-2000 milliliter of patient's plasma will be exchanged with the equal volume of colloidal solution containing 4-5% albumin and fresh frozen plasma (FFP) for two consecutive days. In the next step, plasma therapy will be done with convalescent plasma from patients who recovered from COVID-19.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria, 18 to 65 years, Positive Real Time-Polymerase Chain Reaction test for COVID-19 , exclusion criteria, History of renal disease and dialysis
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Intervention groups
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Treatment is preformed in two steps; step one, plasma exchange with colloidal solution containing 4-5% human albumin and fresh frozen plasma. Step two, plasma therapy with convalescent plasma.
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Main outcome variables
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Size of lesion on lung, Body temperature, The ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage), Respiratory rate, Serum levels of Interleukin 1,6,10, and Tumor necrosis factor alpha, Negative Real Time- Polymerase Chain Reaction