18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Patients With Disease Progression (Intention-to-treat Population)Primary· 15 days
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Patients with a disease-progression event
Group
Value
95% CI
Convalescent Plasma
77
Placebo
81
Hospital admission for any reason
Group
Value
95% CI
Convalescent Plasma
51
Placebo
56
Seeking emergency or urgent care
Group
Value
95% CI
Convalescent Plasma
25
Placebo
25
Death without hospitalization
Group
Value
95% CI
Convalescent Plasma
1
Placebo
0
Number of Patients With Disease Progression (Per-protocol Population)Primary· 15 days
Disease progression defined as death or hospital admission or seeking emergency or urgent care within 15 days of randomization.
Patients with a disease-progression event
Group
Value
95% CI
Convalescent Plasma
71
Placebo
80
Hospital admission for any reason
Group
Value
95% CI
Convalescent Plasma
47
Placebo
55
Seeking emergency or urgent care
Group
Value
95% CI
Convalescent Plasma
24
Placebo
25
Death without hospitalization
Group
Value
95% CI
Convalescent Plasma
0
Placebo
0
Worst Severity Rating on the WHO COVID Ordinal Scale for Clinical Improvement During the 30 Days Following RandomizationSecondary· 30 days
This scale was developed by a special World Health Organization (WHO) committee for quantifying COVID-19 illness severity.
* 1 = Not hospitalized without limitation in activity (no symptoms)
* 2 = Not hospitalized with limitation in activity (continued symptoms)
* 3 = Hospitalized not on supplemental oxygen
* 4 = Hospitalized on supplemental oxygen by mask or nasal prongs
* 5 = Hospitalized on non-invasive ventilation or high flow nasal cannula
* 6 = Hospitalized, intubated and mechanically ventilated
* 7 = Hospitalized, intubated, mechanically ventilated and requiring additional organ suppor
Severity rating 1
Group
Value
95% CI
Convalescent Plasma
55
Placebo
55
Severity rating 2
Group
Value
95% CI
Convalescent Plasma
141
Placebo
133
Severity rating 3
Group
Value
95% CI
Convalescent Plasma
12
Placebo
17
Severity rating 4
Group
Value
95% CI
Convalescent Plasma
28
Placebo
35
Severity rating 5
Group
Value
95% CI
Convalescent Plasma
6
Placebo
5
Severity rating 6
Group
Value
95% CI
Convalescent Plasma
1
Placebo
0
Severity rating 7
Group
Value
95% CI
Convalescent Plasma
2
Placebo
2
Severity rating 8
Group
Value
95% CI
Convalescent Plasma
5
Placebo
1
Number of Patients With Worsening of Symptoms at Day 15 as a Measure of Time to Disease ProgressionSecondary· 15 days
Assessed on the COVID Outpatient Ordinal Outcome Scale censored at 15 days after randomization. Scale provides more granular detail for outpatients than the WHO scale (adapted from Harrell and Lindsell, 2020). Worsening of symptoms is defined as any subject admitted to the hospital (level 1), seen in the emergency room (level 2), a patient who reports increased symptoms of 2 levels on the scale over a 24 hour period, or a patient who reports increased symptoms of 1 level observed for a 48 hour period.
COVID Outpatient Ordinal Outcomes Scale
* 1 = patient requires care in the hospital
* 2 = p
Group
Value
95% CI
Convalescent Plasma
107
Placebo
116
Number of Hospital-free Days During the 30 Days Following RandomizationSecondary· 30 days
Group
Value
95% CI
Convalescent Plasma
28.3
± 4.9
Placebo
28.6
± 3.6
All-cause MortalitySecondary· Assessed at 30 days
Group
Value
95% CI
Convalescent Plasma
5
Placebo
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 30 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The overarching goal of this project is to confirm or refute the role of passive immunization as a safe and efficacious therapy in preventing the progression from mild to severe/critical COVID-19 illness and to understand the immunologic kinetics of anti-SARS-CoV-2 antibodies after passive immunization.The primary objective is to determine the efficacy and safety of a single dose of convalescent plasma (CP) for preventing the progression from mild to severe COVID-19 illness. The secondary objective is to characterize the immunologic response to CP administration.
This study will enroll adults presenting to the emergency department (ED) with mild, symptomatic, laboratory-confirmed COVID-19 illness, who are at high risk for progression to severe/critical illness, but who are clinically stable for outpatient management at randomization.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04539275 — VA CoronavirUs Research and Efficacy Studies-1
· Phase 3
· terminated
NCT04456413 — Convalescent Plasma as Treatment for Subjects With Early COVID-19 Infection
· Phase 2
· terminated
NCT04558476 — Efficacy of CONvalescent Plasma in Patients With COVID-19 Treated With Mechanical Ventilation
· Phase 2
· completed
NCT04513158 — Convalescent Plasma in the Early Treatment of High-Risk Patients With SARS-CoV-2 (COVID-19) Infection
· Phase 2
· terminated
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Currently open trials in the same condition.
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Other Stanford University trials
Trials by the same sponsor.
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· Phase 2
· withdrawn
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· NA
· withdrawn
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· NA
· withdrawn
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· NA
· withdrawn
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· NA
· suspended
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 19 October 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04355767.