Convalescent Plasma for Early Treatment of COVID-19
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|ClinicalTrials.gov Identifier: NCT04390503|
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : July 7, 2021
|Condition or disease||Intervention/treatment||Phase|
|SARS-CoV 2 COVID-19||Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma) Biological: Control (albumin 5%)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||A total of 150 eligible subjects will be randomized in a 2:1 ratio to receive either convalescent plasma qualitatively positive for SARS-CoV-2 antibody (anti-SARS-CoV-2 plasma) or control (albumin 5%)|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||A Phase 2 Randomized, Double-blinded Trial to Evaluate the Efficacy and Safety of Human Anti-SARS-CoV-2 Plasma for Early Treatment of COVID-19|
|Actual Study Start Date :||March 12, 2021|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2022|
Experimental: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Participants randomized to the experimental arm will receive 2 units (approximately 200 to 250 mL per unit, total 400-500mL) of convalescent plasma that was collected from a volunteer who recovered from COVID-19 disease.
Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma)
Convalescent Plasma that contains antibody titers against SARS-CoV-2.
Active Comparator: Control (albumin 5%)
Participants randomized to the control arm will receive 2 units of 250 mL (500mL total) of albumin (human) 5% infusion. The albumin will be prepared in bags that are identical to the bags used for plasma. The similar appearance of albumin and plasma will facilitate maintaining the blinded status of subjects and most of the study staff.
Biological: Control (albumin 5%)
Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.
- Rate of Severe Disease [ Time Frame: Up to 28 days ]The efficacy of treatment will be determined by rating disease severity on Day 28, or last rating evaluated, using a seven-category severity scale.
- Rate of measurable anti-SARS-CoV-2 titers [ Time Frame: Up to 90 days ]To compare the rate of measurable anti-SARS-CoV-2 titers between recipients of CP (anti-SARS-CoV-2 plasma) versus control (albumin 5%).
- Rate of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 28 days ]Compare the rates of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
- Duration of SARS-CoV-2 PCR Positivity [ Time Frame: Up to 28 days ]Compare the duration of SARS-CoV-2 PCR positivity (RT PCR) amongst the anti-SARS-CoV-2 convalescent plasma and control (albumin 5%).
- Levels of SARS-CoV-2 RNA [ Time Frame: Up to 28 days ]Compare the levels of SARS-CoV-2 RNA between the recipients of antiSARS-CoV-2 plasma and control (albumin 5%)
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): NCT04390503
|Contact: Jessica Justman, MDemail@example.com|
|Contact: Jennifer Zech, MScfirstname.lastname@example.org|
|National Institute of Infectious Diseases Evandro Chagas (INI)||Recruiting|
|Rio de Janeiro, Brazil, 21040-900|
|Contact: Beatriz Grinsztejn, MD, PhD email@example.com|
|Principal Investigator: Beatriz Grinsztejn, MD, PhD|
|Principal Investigator:||Jessica Justman, MD||Columbia University|