Convalescent Plasma for COVID-19 Patients (CPCP)

COVID 19 Clinical Trial

— CPCP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04521036
• Other study ID #: ISC.20.11.2
• Status: Completed
• Phase: Phase 1
• Start date: December 1, 2020
• Est. completion date: July 30, 2021

Study information

• Verified date: June 2024
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: July 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID 19
• COVID-19

Intervention

Biological:
• Convalescent Plasma as Therapy for Covid-19 patients
Patients in the treatment group will receive 500 ml from COVID-19 recovered donors

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (4)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology	National Hospital for Tropical Diseases, Hanoi, Vietnam, National Institute of Hematology and Blood Transfusion, Vietnam, National Institute of Hygiene and Epidemiology, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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