Convalescent Plasma for COVID-19 Patients (CPCP)

NCT ID: NCT04521036

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2021-07-30

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.

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.

Conditions

COVID 19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Convalescent plasma

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

Group Type: EXPERIMENTAL

Convalescent Plasma as Therapy for Covid-19 patients

Intervention Type: BIOLOGICAL

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

Standard of care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Convalescent Plasma as Therapy for Covid-19 patients

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Hygiene and Epidemiology, Vietnam

OTHER

Sponsor Role: collaborator

National Hospital for Tropical Diseases, Hanoi, Vietnam

OTHER_GOV

Sponsor Role: collaborator

National Institute of Hematology and Blood Transfusion, Vietnam

OTHER

Sponsor Role: collaborator

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liem Thanh Nguyen, PhD

Role: PRINCIPAL_INVESTIGATOR

Vinmec Research Institute of Stem Cell and Gene Technology

Locations

Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, , Vietnam

Countries

Vietnam

Other Identifiers

ISC.20.11.2

Identifier Type: -

Identifier Source: org_study_id