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Study aim
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Evaluation of the effects of plasma therapy on patient recovery and reduction of disease mortality
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Design
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Clinical trial with control group, with parallel groups,open-label, randomized, phase 3 on 58 patients. Simple randomization method was used as coding method.(A and B )
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Settings and conduct
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Patients referred to Hazrat Vali Asr Hospital in Birjand with COVID 19 infection whose disease has been confirmed by Real Time PCR molecular test or based on CT-Scan symptoms and whose infection is severe or life threatening. They were studied and randomly assigned to the case and control groups. The study was performed as aopen-label study.
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Participants/Inclusion and exclusion criteria
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Willingness to participate in the study
People over the age of 18
People with severe form of COVID-19 disease (shortness of breath, respiratory frequency ≥ 30 / min,, blood oxygen saturation ≤ 93%,, partial pressure of arterial oxygen to fraction of inspired oxygen ratio <300,, percentage of pulmonary involvement more than 50 within 24-48 hours,)
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Intervention groups
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In the intervention group, patients receive 200 ml of convalescent plasma for one turn Improved plasma for one turn in addition to the standard treatment of Covid-19 (Hydroxychloroquine at a dose of 400 mg every 12 hours on the first day, then 200 mg every 12 hours for 14-17 days, or lupinavir-ritonavir at a dose of 400/100 mg for 12 hours for 7 days.).In control group, patients received standard Covid-19 treatment according to the national protocol.
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Main outcome variables
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Urea and creatinine levels, patient liver enzymes, patient oxygen saturation level, temperature, heart rate, systolic blood pressure and level of consciousness