Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19

Sponsor

Metro Infectious Disease Consultants (Other)

Overall Status

Completed

CT.gov ID

NCT04438057

Collaborator

(none)

103

Enrollment

Location

Arms

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

Condition or Disease	Intervention/Treatment	Phase
COVID-19	Biological: CCP	Phase 2

Detailed Description

This study will provide investigational convalescent plasma for patients infected with the SARS-CoV-2 with mild to moderate symptoms who meet inclusion criteria as judged by physician evaluation.

Following patient enrollment into the study, completion of informed consent and randomization, the patient will receive one unit of convalescent COVID plasma or standard of care. The plasma will be infused in an outpatient infusion center by highly trained and experienced staff. Vitalant will be providing the plasma as per their normal screening and distribution protocols. Patients will be monitored for safety during the infusion and per protocol following the infusion for a period of 28 days. Primary efficacy and safety endpoints will be statistically analyzed and compared between the two groups.

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Outpatient open label randomized studyOutpatient open label randomized study

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19

Actual Study Start Date :

Aug 12, 2020

Actual Primary Completion Date :

Aug 12, 2020

Actual Study Completion Date :

Aug 12, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard of Care Patient will receive standard of care therapy.
Active Comparator: Treatment Arm Patient will receive convalescent plasma	Biological: CCP Randomized open label study to receive 2:1 CCP to standard of care Other Names: convalescent plasma

Arm

Intervention/Treatment

No Intervention: Standard of Care

Patient will receive standard of care therapy.

Active Comparator: Treatment Arm

Patient will receive convalescent plasma

Biological: CCP

Randomized open label study to receive 2:1 CCP to standard of care

Other Names:

convalescent plasma

Outcome Measures

Primary Outcome Measures

Time to Resolution of Symptoms [28 days]
a. Time to resolution of symptoms will be defined as time from randomization (day 0) to a successful outcome. c. A successful outcome is defined as symptom improvement of 3 numbers or down to zero on the memory aid for all symptoms noted.
SAEs within 24 hours of plasma infusion [28 days]

Secondary Outcome Measures

Decrease in Inflammatory Markers [28 days]
A 50% decrease at day 28 in C-Reactive Protein (mg/mL)
Decrease in Inflammatory Markers [28 days]
A 50% decrease at day 28 in D-Dimer (ng/mL)
Decrease in Inflammatory Markers [28 days]
A 50% decrease at day 28 in Ferritin (ng/mL)
Decrease in Inflammatory Markers [28 days]
A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)
Hospitalization within 28 days [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Laboratory confirmed diagnosis of infection with SARS-CoV-2
Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
Symptoms less than 14 days
ID Physician determination that the patient does not need hospitalization
O2 saturation of >93%
Informed consent provided by the patient or healthcare proxy
Age ≥ 18 years
Ambulatory Outpatient when informed consent obtained and study drug is administered

Exclusion Criteria:

Age < 18 y/o
Patients currently receiving intravenous immunoglobulin
Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic syndrome, chronic anticoagulation treatment, etc.
Need to be hospitalized
O2 sat < 93%
D-Dimer > 2x normal
Chronic oxygen therapy
Renal insufficiency with Creatinine clearance < 30
Long term care or assisted living facility resident
Ongoing usage of hydroxychloroquine for any indication
History of blood or plasma transfusion related complications
Enrollment into any other investigational drug or device study within the previous 30 days
Any drug, chemical or alcohol dependency as determined by the investigator through history that may affect study procedures and follow up
Pregnant or breast feeding
Any acute or chronic medical comorbidity, psychiatric, social or other circumstance that, in the opinion of the investigator, may interfere with study compliance, completion, or accurate assessment of the study outcomes/safety
Admitted to or expected to be admitted to a medical facility

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Metro Infectious Disease Consultants	Burr Ridge	Illinois	United States	60527

Sponsors and Collaborators

Metro Infectious Disease Consultants

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Metro Infectious Disease Consultants

ClinicalTrials.gov Identifier:

NCT04438057

Other Study ID Numbers:

MIDC-CCP

First Posted:

Jun 18, 2020

Last Update Posted:

Apr 6, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Metro Infectious Disease Consultants

convalescent plasma

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 6, 2022