Prior findings in various viral respiratory diseases including SARS-CoV-related pneumonia suggest that convalescent plasma can reduce mortality, although formal proof of efficacy is still lacking. The investigators propose to evaluate intravenous administration of convalescent plasma (CP) obtained from COVID19 survivors in COVID19 patients who are in the medium stage. Supportive data exist for use of convalescent plasma in the treatment of COVID19 and other overwhelming viral illnesses. The study team wants to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on COVID19 disease severity/duration, with the primary objective to reduce mortality. In addition, a major secondary objective to reduce the requirement for and/or duration of mechanical ventilation. This phase is to test the safety and efficacy of CP therapy.
Coronaviruses are among the most common causes of the common cold in humans. In recent
decades, coronavirus has caused several epidemics worldwide with a vast number of deaths such
as severe acute respiratory syndrome-SARS (2003) with 8098 people infected, and 774 people
died over 29 countries. The disease caused by SARS CoV-2 (COVID19) is manifest by fever,
fatigue, dry cough, pharyngitis, and headache. In addition to the common clinical
presentation of respiratory distress, and increasing frequency of cardiovascular
manifestations has become evident.
In this context, the investigators propose to evaluate the safety and efficacy of intravenous
administration of convalescent plasma (CP) obtained from COVID19 survivors in patients
requiring hospitalization for symptomatic "high risk" COVID19 disease. The study team wants
to test the hypothesis that treatment with COVID19 CP will demonstrate salutary effects on
COVID19 disease severity/duration, with the primary objective to reduce mortality. In
addition, a major secondary objective to reduce the requirement for and/or duration of
mechanical ventilation. This is a randomized clinical trial comparing convalescent plasma
with the standard of care therapy in patients hospitalized for COVID-19 in Vietnam. Patients
were randomized 1:1 and received 500 ml of plasma with anti-SARSCoV-2 neutralizing antibody
titers of at least 1:80.
Written informed consent will be obtained all eligible subjects prior to participation.
Convalescent plasma will be obtained from male donors, nulliparous females, or female donors
negative for HLA antibodies at least 14 days following recovery from COVID-19 infection.
Biological: Convalescent Plasma as Therapy for Covid-19 patients
Patients in the treatment group will receive 500 ml from COVID-19 recovered donors
Inclusion Criteria:
- Age 18-75 years
- SARS-CoV-19 PCR positive
- Moderate stage and above
- Time from onset to screening ≤ 21 days, the SARS-CoV-2 test is still positive
Exclusion Criteria:
- Patients with a history of autoimmune disease or IgA deficiency
- Patients with a history of allergy
- Multi-organ/system failure
- Pregnant or breastfeeding at the time of study
- Cancer, history of heart failure, stroke, bronchial asthma
- Multi-organ/system failure with indications for dialysis, severe hypoxia, failure with
conventional treatment methods, indications for ECMO.
- The patient is infected with multidrug-resistant bacteria.
- The patient is participating in another study.
- Time from onset to screening> 21 days
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam
Phuong Hoang Nguyen, MPH
(+84) 39756885 - 2321
v.phuongnh9@vinmec.com
Liem Thanh Nguyen, PhD
(+84) 39756885 - 2308
v.liemnt@vinmec.com
Liem Thanh Nguyen, PhD, Principal Investigator
Vinmec Research Institute of Stem Cell and Gene Technology