Convalescent Plasma for COVID-19 Patients

COVID 19 Clinical Trial

— CPCP  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04516954
• Other study ID #: ISC.20.11.1
• Status: Enrolling by invitation
• Phase: Early Phase 1
• Start date: August 1, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: August 2020
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Coronaviruses are among the most common causes of the common cold in humans.1,2 In recent decades, coronavirus has caused several epidemic 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 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 single-arm, non-randomized, open-label treatment of eligible subjects defined as those who satisfy all inclusion criteria.

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: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 30, 2020
• Est. primary completion date: November 30, 2020
• 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

• Medium stage

• 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

Intervention

Biological:
• Convalescent COVID 19 Plasma
A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject

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	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	Change in requirement for mechanical ventilatory support	Change in the duration of mechanical ventilation in COVID 19 patients compared with historic precedent cohorts	At Day 28