COVID 19 Clinical Trial
Official title:
Assessment of the Safety of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. The first phase is to test the safety of CP therapy.
Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent
decades, coronavirus has caused several epidemic worldwide with a vast number of deaths such
as severe acute respiratory syndrome-SARS (2003) with 8098 people infected and 774 people
died over 29 countries. The disease caused by SARS CoV-2 (COVID19) is manifest by fever,
fatigue, dry cough, pharyngitis, and headache. In addition to the common clinical
presentation of respiratory distress, and increasing frequency of cardiovascular
manifestations has become evident.
In this context, the investigators propose to evaluate the safety of intravenous
administration of convalescent plasma (CP) obtained from COVID19 survivors in patients
requiring hospitalization for symptomatic "high risk" COVID19 disease. The study team wants
to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on
COVID19 disease severity/duration, with the primary objective to reduce mortality. In
addition, a major secondary objective to reduce the requirement for and/or duration of
mechanical ventilation This is a single-arm, non-randomized, open-label treatment of eligible
subjects defined as those who satisfy all inclusion criteria.
Written informed consent will be obtained all eligible subjects prior to participation.
Convalescent plasma will be obtained from male donors, nulliparous females, or female donors
negative for HLA antibodies at least 14 days following recovery from COVID-19 infection.
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