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COVID-19Phase 2NCT04392414

Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

A Phase 2 study testing COVID-19 convalescent hyperimmune plasma and Non-convalescent fresh frozen plasma (Standard plasma) in people with COVID-19, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19
What is being tested?
COVID-19 convalescent hyperimmune plasma and Non-convalescent fresh frozen plasma (Standard plasma)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteRussia
Study dates
1 May 2020to 23 Sep 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Russia1 site

  • Federal Research Clinical Center of Federal Medical & Biological Agency

    Moscow, 115682

Other trials in Russia

About this study

Official title: Randomized, Open Label, Prospective Study of the Safety and Efficacy of Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

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).

Read the 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.

Conditions
COVID-19
Being tested
COVID-19 convalescent hyperimmune plasma, Non-convalescent fresh frozen plasma (Standard plasma)
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COVID-19 convalescent hyperimmune plasmaBiological

    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)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

Study groups in NCT04392414
Study groupRoleWhat they receive
COVID-19 convalescent hyperimmune plasmaExperimentalModerately and severely ill COVID-19 patients treated with convalescent hyperimmune plasma. Patients will be infused with two units of 300 ml
Receives: Biological: COVID-19 convalescent hyperimmune plasma
Non-convalescent fresh frozen plasma (Standard plasma)Placebo comparatorModerately 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
Receives: Biological: Non-convalescent fresh frozen plasma (Standard plasma)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Days 1, 2, 3, 4, 5, 6, 7

Secondary outcomes (9)

  1. 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.

    Measured: 30 days

  2. 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.

    Measured: 30 days

  3. 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.

    Measured: 30 days

  4. 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.

    Measured: 30 days

  5. 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.

    Measured: Days 0, 14, 30

  6. 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.

    Measured: Days 0, 3, 7

  7. Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors

    Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)

    Measured: Days 3, 7

  8. 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.

    Measured: Days 0, 1, 2, 3, 4, 5, 6, 7

  9. 30-day mortality rate

    30-day mortality rate, for the statistical data comparison between the two arms.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2020
  2. Study start1 May 2020
  3. Primary completion10 Jul 2020
  4. Study completion23 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04392414
Sponsor's protocol ID
CovPlas-Covid19
Status last verified
Jun 2020
First submitted
13 May 2020
Last updated
25 Sep 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no current plan to share individual participant data (IPD).

Publications

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013600. doi: 10.1002/14651858.CD013600.pub6.

    PubMed 37162745

  • Iannizzi C, Chai KL, Piechotta V, Valk SJ, Kimber C, Monsef I, Wood EM, Lamikanra AA, Roberts DJ, McQuilten Z, So-Osman C, Jindal A, Cryns N, Estcourt LJ, Kreuzberger N, Skoetz N. Convalescent plasma for people with COVID-19: a living systematic review. Cochrane Database Syst Rev. 2023 Feb 1;2(2):CD013600. doi: 10.1002/14651858.CD013600.pub5.

    PubMed 36734509

  • 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.

    PubMed 34013969

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing COVID-19 convalescent hyperimmune plasma and Non-convalescent fresh frozen plasma (Standard plasma) in people with COVID-19, run by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: Days 1, 2, 3, 4, 5, 6, 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04392414, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2020.

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