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NCT Number: NCT04392414

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).

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 convalescent hyperimmune plasma

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)

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

Primary outcomes

  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

    Time frame: 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 outcomes

  1. Days before mechanical ventilation

    Time frame: 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.

  2. Days of need for oxygen therapy

    Time frame: 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.

  3. Days of stay in the ICU

    Time frame: 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.

  4. Days of hospitalization

    Time frame: 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.

  5. Changes of the titer of the SARS-CoV-2 antibodies in the blood plasma of patients

    Time frame: 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.

  6. Dynamics of the cytokine profile

    Time frame: 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.

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

    Time frame: Days 3, 7

    Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)

  8. Dynamics of the level of C-reactive protein

    Time frame: 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.

  9. 30-day mortality rate

    Time frame: 30 days

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

Sponsors and collaborators

Lead sponsor

Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Other Gov

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 18, 2020
Registry last updated
Sep 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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