Convalescent Plasma for COVID-19 Patients (CPCP)

NCT04521036 | Completed Phase 1 DMC

• 1 other identifier: ISC.20.11.2
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID 19

Outcome Measures

Primary Outcomes (1)

• Change in mortality

  Change in mortality of high risk COVID 19 disease compared with the control arm

  until hospital discharge or a maximum of 60 days whichever comes first

Secondary Outcomes (3)

• Change in requirement for mechanical ventilation

  until hospital discharge or a maximum of 60 days whichever comes first

• Change in the duration of mechanical ventilation

  until hospital discharge or a maximum of 60 days whichever comes first

• Incidence of Treatment-Emergent Adverse Events

  Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first

Study Arms (2)

Convalescent plasma

EXPERIMENTAL

Standard of care plus 500 mL of convalescent plasma from COVID-19 recovered donors

Biological: Convalescent Plasma as Therapy for Covid-19 patients

Standard of care

NO INTERVENTION

Standard of care (Supportive care, oxygen, antibiotics, no convalescent plasma)

Interventions

Convalescent Plasma as Therapy for Covid-19 patients BIOLOGICAL

Patients in the treatment group will receive 500 ml from COVID-19 recovered donors

Convalescent 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
• Moderate stage and above
• 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, 100000, Vietnam

Location

MeSH Terms

Conditions

COVID-19

Interventions

Therapeutics

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

Study Officials

• Liem Thanh Nguyen, PhD

  Vinmec Research Institute of Stem Cell and Gene Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care

Study Record Dates

• First Submitted: August 18, 2020
• First Posted: August 20, 2020
• Study Start: December 1, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 30, 2021
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)