Hyperimmune Convalescent Plasma in Moderate and Severe COVID-19 Disease

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04392414
• Other study ID #: CovPlas-Covid19
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2020
• Est. completion date: September 23, 2020

Study information

• Verified date: June 2020
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 23, 2020
• Est. primary completion date: July 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

Biological:
• COVID-19 convalescent hyperimmune plasma
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)
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

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center of Federal Medical & Biological Agency	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	30 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	30 days
Secondary	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.	Days 0, 14, 30
Secondary	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.	Days 0, 3, 7
Secondary	Incidence of the cytokine storm development and the need of administering cytokine storm inhibitors	Incidence of administering IL6 receptor blockers (tocilizumab, sarilumab)	Days 3, 7
Secondary	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.	Days 0, 1, 2, 3, 4, 5, 6, 7
Secondary	30-day mortality rate	30-day mortality rate, for the statistical data comparison between the two arms.	30 days