Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

Phase 2

Completed

• Conditions: COVID-19
• Interventions: Biological: Non-convalescent fresh frozen plasma (Standard plasma); Biological: COVID-19 convalescent hyperimmune plasma

• Registration Number: NCT04392414
• Lead Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

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 with non-convalescent fresh frozen plasma (standard plasma).

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 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 Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Status Verified: 2020-06
• Primary Completion: 2020-07-10
• Study Completion: 2020-09-23
• Last Update Submitted: 2020-09-23
• Last Update Posted: 2020-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-convalescent fresh frozen plasma (Standard plasma)	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
COVID-19 convalescent hyperimmune plasma	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

Primary Outcome Measures

Name	Time	Method
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	Days 1, 2, 3, 4, 5, 6, 7	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.

Secondary Outcome Measures

Name	Time	Method
Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors	Days 3, 7	Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)
30-day mortality rate	30 days	30-day mortality rate, for the statistical data comparison between the two arms.
Dynamics of the cytokine profile	Days 0, 3, 7	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.
Days before mechanical ventilation	30 days	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.
Dynamics of the level of C-reactive protein	Days 0, 1, 2, 3, 4, 5, 6, 7	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.
Days of need for oxygen therapy	30 days	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.
Days of stay in the ICU	30 days	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.
Days of hospitalization	30 days	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.
Changes of the titer of the SARS-CoV-2 antibodies in the blood plasma of patients	Days 0, 14, 30	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.

Trial Locations

Locations (1)

Federal Research Clinical Center of Federal Medical & Biological Agency; 🇷🇺 Moscow, Russian Federation