Clinical trial NCT04521036: Convalescent Plasma for COVID-19 Patients (CPCP)
Official title: Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COVID 19
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
Collaborators: name: National Institute of Hygiene and Epidemiology, Vietnam
name: National Hospital for Tropical Diseases, Hanoi, Vietnam
name: National Institute of Hematology and Blood Transfusion, Vietnam
First posted: 2020-08-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in mortality
timeFrame: until hospital discharge or a maximum of 60 days whichever comes first
Secondary outcomes:
measure: Change in requirement for mechanical ventilation
timeFrame: until hospital discharge or a maximum of 60 days whichever comes first
measure: Change in the duration of mechanical ventilation
timeFrame: until hospital discharge or a maximum of 60 days whichever comes first
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Research Institute of Stem Cell and Gene Technology
name: Liem Thanh Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
References: