NCT04502472: Inova-CCP

Treatment of Severe Coronavirus Disease 2019 (COVID-19) With Convalescent Plasma

Terminated Phase 2, PHASE3 Results posted Last updated 10 January 2022

What this trial tests

Phase 2, PHASE3 trial testing Convalescent plasma transfusion in Covid-19 in 109 participants. Terminated before completion.

Timeline

6 June 2020

Primary endpoint
30 September 2020

30 September 2020

Quick facts

Lead sponsor	Inova Health Care Services
Phase	Phase 2, PHASE3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	109
Start date	6 June 2020
Primary completion	30 September 2020
Estimated completion	30 September 2020
Sites	1 location across United States

Drugs / interventions tested

• Convalescent plasma transfusion — full drug profile →

Conditions studied

• Covid-19 — all drugs for Covid-19 →

Sponsor

Inova Health Care Services — full company profile →

Who can join

18 and older, any sex, with Covid-19. 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.

Change is Clinical Status Primary · Time of plasma infusion (day 0) compared to day 7

Change is clinical status as captured by 7-point ordinal scale to include 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized

Average Day 1 Ordinal Scale

Group	Value	95% CI
Patients Hospitalized With COVID-19	3.06	1 – 7

Average Day 7 Ordinal Scale

Group	Value	95% CI
Patients Hospitalized With COVID-19	3.86	1 – 7

Transfusion Related Events Due to Administration of CCP Primary · Within 6 hours of infusion

Number of participants with Transfusion Related Adverse Events

Group	Value	95% CI
Patients Hospitalized With COVID-19	3

Change is Clinical Status Secondary · Time of plasma infusion (day 0 prior to first infusion) to days 7,14, 21, and 28

Change in 7-point ordinal scale score from time of plasma infusion (day 0-prior to first infusion) to days 7, 14, 21, and 28. 7 point ordinal scale: 1. Death 2. Hospitalized, requiring mechanical ventilation or ECMO 3. Hospitalized, requiring non-invasive ventilation or high flow oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, not requiring supplemental oxygen--requiring ongoing medical care (COVID-19 related or otherwise) 6. Hospitalized, not requiring supplemental oxygen-not requiring ongoing medical care (COVID-19 related or otherwise). 7. Not Hospitalized

Ordinal Scale Day 0

Group	Value	95% CI
Patients Hospitalized With COVID-19	10
Patients Hospitalized With COVID-19	22
Patients Hospitalized With COVID-19	13
Patients Hospitalized With COVID-19	0

Ordinal Scale Day 7

Group	Value	95% CI
Patients Hospitalized With COVID-19	11
Patients Hospitalized With COVID-19	6
Patients Hospitalized With COVID-19	10
Patients Hospitalized With COVID-19	1

Ordinal Scale Day 14

Group	Value	95% CI
Patients Hospitalized With COVID-19	5
Patients Hospitalized With COVID-19	3
Patients Hospitalized With COVID-19	5
Patients Hospitalized With COVID-19	0

Ordinal Scale Day 21

Group	Value	95% CI
Patients Hospitalized With COVID-19	5
Patients Hospitalized With COVID-19	1
Patients Hospitalized With COVID-19	3
Patients Hospitalized With COVID-19	0

Ordinal Scale Day 28

Group	Value	95% CI
Patients Hospitalized With COVID-19	2
Patients Hospitalized With COVID-19	2
Patients Hospitalized With COVID-19	1
Patients Hospitalized With COVID-19	0

Length of Hospital Stay Secondary · Total Index Hospitalization

Total duration of hospital stay which includes from Admission with COVID-19 from admission with COVID-19 symptoms to discharge or death (up to an average of 67 days)

Group	Value	95% CI
Patients Hospitalized With COVID-19	20	4 – 67

Mechanical Ventilation Secondary · Days 7, 14, 21, 28

Number of participants that required mechanical ventilation that were not on mechanical ventilation at that time point.

Day 7

Group	Value	95% CI
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	11
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	17
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	5
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	12

Day 14

Group	Value	95% CI
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	5
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	8
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	11
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	21

Day 21

Group	Value	95% CI
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	5
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	4
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	13
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	23

Day 28

Group	Value	95% CI
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	2
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	3
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	14
Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion	26

Change in Mechanical Ventilation Status Secondary · Day 0 (date of CCP transfusion) to Day 28

Number of participants who required a change in the mechanical ventilation status

Group	Value	95% CI
Patients Hospitalized With COVID-19	6

Mortality Secondary · From Day of Transfusion (Day 0) to Day 28 post-transfusion for patients who received CCP. Patients who donated CCP were not followed for a defined time period after CCP donation.

All-cause Mortality

Group	Value	95% CI
Patients Hospitalized With COVID-19	14
Patients Recovered From COVID-19	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Patients were monitored for up to 67 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Recipient of COVID-19 Convalescent Plasma (CCP) Transfusion

Serious: 21/45 (47%)

Deaths: 14/45

Serious adverse events (3 terms)

Reaction	System	Recipient of COVID-19 Conv…
Death	Respiratory, thoracic and mediastinal disorders	—
Intubation	Respiratory, thoracic and mediastinal disorders	—
transfusion reaction	Blood and lymphatic system disorders	—

Most-reported serious reactions: Death, Intubation, transfusion reaction.

Data from ClinicalTrials.gov NCT04502472 adverse events section.

Sponsor's own description

The investigators hypothesize that use of convalescent plasma donated from individuals recovered from Coronavirus Disease 2019 (COVID-19) will help expedite recovery of individuals with active, severe COVID-19 infection.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
2. Convalescent plasma or hyperimmune immunoglobulin for people with COVID-19: a living systematic review.
   Piechotta V, Iannizzi C, Chai KL, Valk SJ, et al · · 2021 · cited 106× · PMID 34013969 · DOI 10.1002/14651858.cd013600.pub4
3. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 24× · PMID 36734509 · DOI 10.1002/14651858.cd013600.pub5
4. Convalescent plasma for people with COVID-19: a living systematic review.
   Iannizzi C, Chai KL, Piechotta V, Valk SJ, et al · · 2023 · cited 21× · PMID 37162745 · DOI 10.1002/14651858.cd013600.pub6