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Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

Primary Purpose

COVID-19

Status
Completed
Phase
Phase 2
Locations
Russian Federation
Study Type
Interventional
Intervention
COVID-19 convalescent hyperimmune plasma
Non-convalescent fresh frozen plasma (Standard plasma)
Sponsored by
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal Research Clinical Center of Federal Medical & Biological Agency

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

COVID-19 convalescent hyperimmune plasma

Non-convalescent fresh frozen plasma (Standard plasma)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors
Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)
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.
30-day mortality rate
30-day mortality rate, for the statistical data comparison between the two arms.

Full Information

First Posted
May 13, 2020
Last Updated
September 23, 2020
Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT04392414
Brief Title
Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease
Official Title
Randomized, Open Label, Prospective Study of the Safety and Efficacy of Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
July 10, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COVID-19 convalescent hyperimmune plasma
Arm Type
Experimental
Arm Description
Moderately and severely ill COVID-19 patients treated with convalescent hyperimmune plasma. Patients will be infused with two units of 300 ml
Arm Title
Non-convalescent fresh frozen plasma (Standard plasma)
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
COVID-19 convalescent hyperimmune plasma
Intervention Description
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
Intervention Name(s)
Non-convalescent fresh frozen plasma (Standard plasma)
Intervention Description
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
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Days before mechanical ventilation
Description
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
Title
Days of need for oxygen therapy
Description
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
Title
Days of stay in the ICU
Description
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
Title
Days of hospitalization
Description
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
Title
Changes of the titer of the SARS-CoV-2 antibodies in the blood plasma of patients
Description
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
Title
Dynamics of the cytokine profile
Description
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
Title
Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors
Description
Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)
Time Frame
Days 3, 7
Title
Dynamics of the level of C-reactive protein
Description
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
Title
30-day mortality rate
Description
30-day mortality rate, for the statistical data comparison between the two arms.
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander V Averyanov, MD, PhD
Organizational Affiliation
Federal Pulmonology Scientific and Research Institute, FMBA of Russia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vladimir P Baklaushev, MD, PhD
Organizational Affiliation
Federal Research Clinical Center, FMBA of Russia
Official's Role
Study Director
Facility Information:
Facility Name
Federal Research Clinical Center of Federal Medical & Biological Agency
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share individual participant data (IPD).
Citations:
PubMed Identifier
34013969
Citation
Piechotta V, Iannizzi C, Chai KL, Valk SJ, Kimber C, Dorando E, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Estcourt LJ, Skoetz N. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2021 May 20;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub4.
Results Reference
derived

Learn more about this trial

Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

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