The clinical trial aims to study the safety and efficacy of transfusion of COVID-19 convalescent hyperimmune plasma for the treatment of moderate and severe forms of COVID-19 disease in comparison with non-convalescent fresh frozen plasma (standard plasma).
This is a study of the safety and efficacy of the use of COVID-19 convalescent plasma (from subjects who have recovered from SARS-CoV-2) in the treatment of moderate and severe forms of the SARS-CoV-2 infection. Currently, there are no registered drugs for the treatment of the SARS-CoV-2 infection in the world. The use of hyperimmune plasma is a well-known method used for many decades to treat many dangerous infections. The effectiveness of such a therapy for COVID-19 patients has recently been demonstrated in a number of clinical studies in China. Therefore, we plan to study the feasibility of administering multiple doses of COVID-19 convalescent plasma in comparison with standard plasma to moderate and severe patients with COVID-19.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Subjects to receive double convalescent hyperimmune plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one
Subjects to receive double standard plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, Russia
The number and proportion of patients with the normal body temperature (≤37.2 C) at the day 1, 2, 3, 4, 5, 6, 7 after the start of therapy
The number and proportion of patients with the normal body temperature (≤37.2 C) at the days 1, 2, 3, 4, 5, 6, 7 after the start of therapy, for the statistical data comparison between the two arms.
Time frame: Days 1, 2, 3, 4, 5, 6, 7
Days before mechanical ventilation
For each patient, the number of days passed from the plasma administration to placing on mechanical ventilation will be noted, for the statistical data comparison between the two arms.
Time frame: 30 days
Days of need for oxygen therapy
For each patient, the number of days he or she spent on the oxygen support after the plasma administration will be noted, for the statistical data comparison between the two arms.
Time frame: 30 days
Days of stay in the ICU
For each patient, the entire duration of ICU stay after the plasma administration will be noted, for the statistical data comparison between the two arms.
Time frame: 30 days
Days of hospitalization
For each patient, the entire duration of hospital stay after the plasma administration will be noted, for the statistical data comparison between the two arms.
Time frame: 30 days
Changes of the titer of the SARS-CoV-2 antibodies in the blood plasma of patients
Changes of the plasma levels of the SARS-CoV-2 antibodies, days 14 and 30 after the treatment start vs those levels before the treatment start (day 0) for the same patients.
Time frame: Days 0, 14, 30
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Dynamics of the cytokine profile
Changes of the plasma levels of IL2, IL6, IL10, TNFalpha and INFgamma, days 3 and 7 after the treatment start vs those levels before the treatment start (day 0) for the same patients.
Time frame: Days 0, 3, 7
Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors
Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)
Time frame: Days 3, 7
Dynamics of the level of C-reactive protein
Changes of the plasma levels of C-reactive protein, days 1, 2, 3, 4, 5, 6, 7 after the treatment start vs those levels before the treatment start (Day 0) for the same patients.
Time frame: Days 0, 1, 2, 3, 4, 5, 6, 7
30-day mortality rate
30-day mortality rate, for the statistical data comparison between the two arms.
Time frame: 30 days