Convalescent Plasma for COVID-19 Patients (CPCP) (CPCP)
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|ClinicalTrials.gov Identifier: NCT04521036|
Recruitment Status : Not yet recruiting
First Posted : August 20, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID 19||Biological: Convalescent Plasma as Therapy for Covid-19 patients||Phase 1 Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||This trial is a randomized comparative trial. Patients will be randomized between the infusion of 500mL of Convalescent Plasma versus the standard of care|
|Masking:||None (Open Label)|
|Official Title:||Assessment of the Safety and Efficacy of Convalescent Plasma to Treat COVID-19 Patients With Moderate and Above Illness|
|Estimated Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||June 30, 2021|
|Estimated Study Completion Date :||October 30, 2021|
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)
- Change in mortality [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]Change in mortality of high risk COVID 19 disease compared with the control arm
- Change in requirement for mechanical ventilation [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]Change in the duration of mechanical ventilation in high risk COVID 19 disease compared with the control arm
- Change in the duration of mechanical ventilation [ Time Frame: until hospital discharge or a maximum of 60 days whichever comes first ]Change in the time a participant will remain on the ventilator
- Incidence of Treatment-Emergent Adverse Events [ Time Frame: Incidence of Treatment-Emergent Adverse Events until hospital discharge or a maximum of 60 days whichever comes first ]Incidence of Treatment-Emergent Adverse Events during study period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04521036
|Contact: Phuong Hoang Nguyen, MPH||(+84) 39756885 ext email@example.com|
|Contact: Liem Thanh Nguyen, PhD||(+84) 39756885 ext firstname.lastname@example.org|
|Vinmec Research Institute of Stem Cell and Gene Technology|
|Hanoi, Vietnam, 100000|
|Principal Investigator:||Liem Thanh Nguyen, PhD||Vinmec Research Institute of Stem Cell and Gene Technology|