Convalescent Plasma for Early Treatment of COVID-19
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ClinicalTrials.gov Identifier: NCT04390503 |
Recruitment Status :
Terminated
(Enrollment challenges)
First Posted : May 15, 2020
Last Update Posted : June 30, 2022
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV 2 COVID-19 | Biological: Convalescent Plasma (anti-SARS-CoV-2 plasma) Biological: Control (albumin 5%) | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 89 participants |
Allocation: | Randomized |
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) |
Primary Purpose: | Treatment |
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 |
Actual Primary Completion Date : | January 6, 2022 |
Actual Study Completion Date : | January 6, 2022 |

Arm | Intervention/treatment |
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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.
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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.
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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%)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Subjects must be 18 years of age or older
- Recent close contact with a person with COVID-19, i.e. last close contact occurred within 7 days of anticipated infusion of study product. It is anticipated that most contacts will be household contacts with extensive interaction. All must meet the CDC criteria for close contacts. This includes healthcare workers at higher risk of developing severe disease.
OR
- Recent self-reported or documented evidence of infection by nasal swab PCR that is positive for SARS-CoV-2, i.e., nasal sample was collected within 7 days or 10 days of anticipated infusion of study product for those who are asymptomatic or symptomatic, respectively.
- Evidence of infection by nasal swab PCR that is positive for SARS-CoV-2 at screening visit.
- May or may not be hospitalized.
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No symptoms or no more than 5 days of mild symptoms at the time of screening. Mild symptoms (rated by participant as mild and not interfering with normal daily activities) may include:
- Mild rhinorrhea
- Mild sore throat or throat irritation
- Mild nonproductive cough
- Mild fatigue (able to perform Activities of Daily Living (ADLs))
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Risk for severe COVID-19 based on a risk score of ≥ 1 Calculated Risk Score of ≥ 1 point, with risk factors based on Center for Disease Control and Prevention (CDC) description
- Age 65-74: 1 point
- Age ≥ 75: 2 points
- Known cardiovascular disease (including hypertension): 1 point
- Diabetes mellitus: 1 point
- Pulmonary disease (COPD, moderate to severe asthma, current smoking or other): 1 point
- Morbid obesity: 1 point
- Immunocompromised state: 1 point Received a bone marrow or solid organ transplant at any time, received chemotherapy for a malignancy within the past 6 months, has an acquired or congenital immunodeficiency, currently receiving immunosuppressive or immune modulating medications, HIV with non-suppressed viral load and/or cluster of differentiation 4 (CD4+) T cell count <200 cells/mL).
Exclusion Criteria:
- Receipt of any blood product in past 120 days.
- Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance.
- Confirmed or self-reported presumed COVID-19, with symptoms that began more than 5 days prior to enrollment, and SARS-CoV-2 PCR positive sample that was collected more than 7 days prior to anticipated infusion for an asymptomatic participant or more than 10 days prior to anticipated infusion for a patient with mild symptoms at screening.
- Symptoms consistent with COVID---19 infection that are more than mild (as defined above) at time of screening.
- Symptoms consistent with COVID---19 infection that are more than mild at time of screening.
- History of allergic reaction to transfusion blood products
- Inability to complete infusion of the product within 48 hours after randomization.
- Resident of a long term or skilled nursing facility
- Known prior diagnosis of immunoglobulin A (IgA) deficiency
- Oxygen saturation that is < 95% at the screening visit
- On supplemental oxygen at time of enrollment
- Participation in another clinical trial of anti-viral agent(s) for COVID-19
- Receipt of any COVID-19 vaccine, either as part of a clinical research trial or through routine service delivery.

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
Brazil | |
National Institute of Infectious Diseases Evandro Chagas (INI) | |
Rio de Janeiro, Brazil, 21040-900 |
Principal Investigator: | Jessica Justman, MD | Columbia University |
Responsible Party: | Andrew Eisenberger, Associate Professor of Medicine, Columbia University |
ClinicalTrials.gov Identifier: | NCT04390503 |
Other Study ID Numbers: |
AAAT0052 |
First Posted: | May 15, 2020 Key Record Dates |
Last Update Posted: | June 30, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Coronavirus COVID Convalescent Plasma |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |