Convalescent Plasma for COVID-19 Patients (CPCP) (CPCP)

Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness

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.

Study Overview

• Status: Completed
• Conditions: COVID 19
• Intervention / Treatment: Biological: Convalescent Plasma as Therapy for Covid-19 patients

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

Study Locations

• Vietnam
  • Hanoi, Vietnam, 100000
    • Vinmec Research Institute of Stem Cell and Gene Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Convalescent plasma; Standard of care plus 500 mL of convalescent plasma from COVID-19 recovered donors	Biological: Convalescent Plasma as Therapy for Covid-19 patients; Patients in the treatment group will receive 500 ml from COVID-19 recovered donors
No Intervention: Standard of care; Standard of care (Supportive care, oxygen, antibiotics, no convalescent plasma)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in requirement for mechanical ventilation	Change in the duration of mechanical ventilation in high risk COVID 19 disease compared with the control arm	until hospital discharge or a maximum of 60 days whichever comes first
Change in the duration of mechanical ventilation	Change in the time a participant will remain on the ventilator	until hospital discharge or a maximum of 60 days whichever comes first
Incidence of Treatment-Emergent Adverse Events	Incidence of Treatment-Emergent Adverse Events during study period	Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first

Collaborators and Investigators

• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
• Collaborators: National Institute of Hygiene and Epidemiology, Vietnam; National Hospital for Tropical Diseases, Hanoi, Vietnam; National Institute of Hematology and Blood Transfusion, Vietnam
• Investigators: Principal Investigator: Liem Thanh Nguyen, PhD, Vinmec Research Institute of Stem Cell and Gene Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): July 30, 2021

Study Registration Dates

• First Submitted: August 18, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 3, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: ISC.20.11.2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No