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

NCT ID: NCT04438057

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-12
• Study Completion Date: 2021-08-12

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.

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.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care

Patient will receive standard of care therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment Arm

Patient will receive convalescent plasma

Group Type: ACTIVE_COMPARATOR

CCP

Intervention Type: BIOLOGICAL

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

Interventions

CCP

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

Intervention Type: BIOLOGICAL

Other Intervention Names

convalescent plasma

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Metro Infectious Disease Consultants

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Metro Infectious Disease Consultants

Burr Ridge, Illinois, United States

Countries

United States

Other Identifiers

MIDC-CCP

Identifier Type: -

Identifier Source: org_study_id