Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

NCT04392414 | Completed Phase 2

• 1 other identifier: CovPlas-Covid19
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

COVID-19

Outcome Measures

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

  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.

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

Secondary Outcomes (9)

• Days before mechanical ventilation

  30 days

• Days of need for oxygen therapy

  30 days

• Days of stay in the ICU

  30 days

• Days of hospitalization

  30 days

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

  Days 0, 14, 30

Study Arms (2)

COVID-19 convalescent hyperimmune plasma

EXPERIMENTAL

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

Biological: COVID-19 convalescent hyperimmune plasma

Non-convalescent fresh frozen plasma (Standard plasma)

PLACEBO COMPARATOR

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

Biological: Non-convalescent fresh frozen plasma (Standard plasma)

Interventions

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

COVID-19 convalescent hyperimmune plasma

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

Non-convalescent fresh frozen plasma (Standard plasma)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research Clinical Center of Federal Medical & Biological Agency, Russia: lead

Study Sites (1)

Federal Research Clinical Center of Federal Medical & Biological Agency

Moscow, 115682, Russia

Location

Related Publications (3)

• 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.

  PMID: 37162745 DERIVED

• 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.

  PMID: 36734509 DERIVED

• 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.

  PMID: 34013969 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Officials

• Alexander V Averyanov, MD, PhD

  Federal Pulmonology Scientific and Research Institute, FMBA of Russia

  PRINCIPAL INVESTIGATOR

• Vladimir P Baklaushev, MD, PhD

  Federal Research Clinical Center, FMBA of Russia

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 18, 2020
• Study Start: May 1, 2020
• Primary Completion: July 10, 2020
• Study Completion: September 23, 2020
• Last Updated: September 25, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)