Clinical trial NCT04516954: Convalescent Plasma for COVID-19 Patients
Official title: Assessment of the Safety of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_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: 2020-08-18
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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. The first phase is to test the safety of CP therapy.

Detailed description: Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent decades, coronavirus has caused several epidemic 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 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 single-arm, non-randomized, open-label treatment of eligible subjects defined as those who satisfy all inclusion criteria.

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
* Medium stage
* 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: Evaluate the safety
timeFrame: At Day 28
Secondary outcomes:
measure: Change in requirement for mechanical ventilatory support
timeFrame: At Day 28
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem cell and Gene Technology
Study officials:
References: