Convalescent Plasma for COVID-19 Patients

NCT04516954 | Completed Early Phase 1 DMC

• 1 other identifier: ISC.20.11.1
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

• Evaluate the safety

  Number of Adverse Events (AEs), and Serious Adverse Events (SAEs) of COVID 19 Patients: Incidence of Treatment-Emergent Adverse Events (Data on the number of participants with treatment related adverse events will be assessed to determine the safety and tolerability of convalescent plasma)

  At Day 28

Secondary Outcomes (1)

• Change in requirement for mechanical ventilatory support

  At Day 28

Study Arms (1)

Convalescent COVID 19 Plasma

EXPERIMENTAL

A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject

Biological: Convalescent COVID 19 Plasma

Interventions

Convalescent COVID 19 Plasma BIOLOGICAL

A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject

Convalescent COVID 19 Plasma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vinmec Research Institute of Stem Cell and Gene Technology: lead
• National Institute of Hygiene and Epidemiology, Vietnam: collaborator
• National Hospital for Tropical Diseases, Hanoi, Vietnam: collaborator
• National Institute of Hematology and Blood Transfusion, Vietnam: collaborator

Study Sites (1)

Vinmec Research Institute of Stem cell and Gene Technology

Hanoi, 10000, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Serotherapy

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 18, 2020
• Study Start: August 1, 2020
• Primary Completion: March 30, 2021
• Study Completion: April 30, 2021
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)