Convalescent Plasma as Treatment for Hospitalized Subjects With COVID-19 Infection

Phase 2

Terminated

• Conditions: COVID-19
• Interventions: Biological: Convalescent Plasma

• Registration Number: NCT04343755
• Lead Sponsor: Hackensack Meridian Health

Brief Summary

* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.

* Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.

* Interim analysis will be permitted as described in the statistical section 8.

* The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

Detailed Description

Overall study design

* This is a single arm phase IIa study of convalescent plasma for the treatment of individuals hospitalized with COVID-19 infection.

* Subjects will be considered as having completed the study after 60 (+/- 3) days, unless consent withdrawal or death occurs first.

* Interim analysis will be permitted as described in the statistical section 8.

* The final analysis will be conducted once the last subject completes the day 60 visit or withdraws from the study.

Number of subjects

• Up to 36 patients in track 2, and 19 patients in track 3 as described in the statistical section 8.

Overall study duration

* The study begins when the first subject (this will likely be a donor) signs the informed consent. The study will end once the last enrolled subject completes the study (likely a recipient).

* The expected duration of the study is approximately 12 months.

Study Timeline

• Study First Submitted: 2020-04-08
• Study Start: 2020-04-09
• Study First Submitted QC: 2020-04-09
• Study First Posted: 2020-04-13
• Primary Completion: 2023-04-26
• Study Completion: 2023-04-26
• Results First Submitted: 2023-06-22
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-15
• Last Update Submitted: 2023-09-15
• Results First Posted: 2023-09-18
• Last Update Posted: 2023-09-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Convalescent Plasma	Convalescent Plasma	Fresh or frozen plasma will be infused one time to patients

Primary Outcome Measures

Name	Time	Method
Number of Participants Hospitalized for COVID-19 But Not Intubated	7 Days	Mechanical ventilation rate at 7 days from starting treatment in hospitalized COVID-19 patients
Primary Objective for Patients With COVID-19 Already Intubated	30 Days	Mortality rate at 30 days from starting treatment for patients with COVID-19

Secondary Outcome Measures

Name	Time	Method
Time to Symptoms Resolution	60 Days	The time to symptom resolution is defined as the time in days from new therapy initiation to the first documented symptom resolution as assessed by local site. Patients whose symptom are not resolved, who are dead, or lost follow-up on the designed follow-up date will be censored on that date.
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 30	30 Days
Impact of Donor Titers Level on Efficacy	60 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Days 0 (Pre-infusion)	0 Days (pre-infusion)
Duration of Hospitalization	60 Days	The duration of hospitalization is defined as the time in days from the first day of hospitalized to the date of discharge or death. Patients who are not discharged, are alive and still in the hospital on the date of closing follow-up, or lost follow-up on the date of closing follow-up will be considered censored on that date.
Duration of Mechanical Ventilation	60 Days	The duration of mechanical ventilation is defined as the time in days from the first day of using mechanical ventilation to the last day of using mechanical ventilation. All evaluable patients will be included and no censoring for this analysis.
Impact of Donor Titers Level on Safety	60 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Days 3	3 Days
Overall Survival	60 Days	Overall survival rate at 60 days from starting treatment for patients with COVID-19
Rate of Virologic Clearance by Nasopharyngeal Swab at Day 10	10 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 10	10 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 30	30 Days
Recipient Anti-SARS-CoV2 Titer Assessment on Day 60	60 Days

Trial Locations

Locations (1)

Hackensack University Medical Center; 🇺🇸 Hackensack, New Jersey, United States