Status:
COMPLETED
Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease
Lead Sponsor:
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Conditions:
COVID-19
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 wit...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Men or women aged 18-75 years.
- The presence of COVID-19 infection, confirmed by PCR testing
- The presence of the COVID-19 pneumonia pattern on the chest HRCT with a damage to more than 25% of the lung parenchyma
- Morning fever ≥ 38.0 °C over the last three days
- CRP blood level ≥ 50 mg / ml or ferritin blood level ≥ 600 μg / ml
- A signed informed consent
Exclusion
- Respiratory index ≤200
- Contraindications for the transfusion of donor immune plasma or history of prior reactions to blood transfusions
- Mechanical ventilation
- The presence of chronic lung diseases with chronic respiratory failure.
- The need for home continuous oxygen therapy before the onset of current disease.
- Serum creatinine level higher than 150 μmol / l
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
May 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 23 2020
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04392414
Start Date
May 1 2020
End Date
September 23 2020
Last Update
September 25 2020
Active Locations (1)
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1
Federal Research Clinical Center of Federal Medical & Biological Agency
Moscow, Russia, 115682