Clinical trial NCT04392414: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Lead sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Sponsor class: OTHER_GOV
First posted: 2020-05-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: Days 1, 2, 3, 4, 5, 6, 7
Secondary outcomes:
measure: Days before mechanical ventilation
timeFrame: 30 days
measure: Days of need for oxygen therapy
timeFrame: 30 days
measure: Days of stay in the ICU
timeFrame: 30 days
measure: Days of hospitalization
timeFrame: 30 days
measure: Changes of the titer of the SARS-CoV-2 antibodies in the blood plasma of patients
timeFrame: Days 0, 14, 30
measure: Dynamics of the cytokine profile
timeFrame: Days 0, 3, 7
measure: Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors
timeFrame: Days 3, 7
measure: Dynamics of the level of C-reactive protein
timeFrame: Days 0, 1, 2, 3, 4, 5, 6, 7
measure: 30-day mortality rate
timeFrame: 30 days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Federal Research Clinical Center of Federal Medical & Biological Agency
Study officials:
affiliation: Federal Pulmonology Scientific and Research Institute, FMBA of Russia
name: Alexander V Averyanov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Research Clinical Center, FMBA of Russia
name: Vladimir P Baklaushev, MD, PhD
role: STUDY_DIRECTOR
References:
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.