Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-01

Study Completion Date

2020-09-23

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COVID-19 convalescent hyperimmune plasma

Moderately and severely ill COVID-19 patients treated with convalescent hyperimmune plasma. Patients will be infused with two units of 300 ml

Group Type EXPERIMENTAL

COVID-19 convalescent hyperimmune plasma

Intervention Type BIOLOGICAL

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

Non-convalescent fresh frozen plasma (Standard plasma)

Moderately and severely ill COVID-19 patients treated with non-convalescent fresh frozen plasma (standard plasma). Patients will be infused with two units of 300 ml

Group Type PLACEBO_COMPARATOR

Non-convalescent fresh frozen plasma (Standard plasma)

Intervention Type BIOLOGICAL

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

Interventions

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COVID-19 convalescent hyperimmune plasma

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

Intervention Type BIOLOGICAL

Non-convalescent fresh frozen plasma (Standard plasma)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

1. Men or women aged 18-75 years.
2. The presence of COVID-19 infection, confirmed by PCR testing
3. The presence of the COVID-19 pneumonia pattern on the chest HRCT with a damage to more than 25% of the lung parenchyma
4. Morning fever ≥ 38.0 °C over the last three days
5. CRP blood level ≥ 50 mg / ml or ferritin blood level ≥ 600 μg / ml
6. A signed informed consent

Exclusion Criteria

1. Respiratory index ≤200
2. Contraindications for the transfusion of donor immune plasma or history of prior reactions to blood transfusions
3. Mechanical ventilation
4. The presence of chronic lung diseases with chronic respiratory failure.
5. The need for home continuous oxygen therapy before the onset of current disease.
6. Serum creatinine level higher than 150 μmol / l
7. Pregnancy or breastfeeding

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No