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

NCT04438057 | Completed Phase 2 FDA Drug

• 1 other identifier: MIDC-CCP
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

convalescent plasma

Outcome Measures

Primary Outcomes (2)

• Time to Resolution of Symptoms

  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.

  28 days

• SAEs within 24 hours of plasma infusion

  28 days

Secondary Outcomes (5)

• Decrease in Inflammatory Markers

  28 days

• Decrease in Inflammatory Markers

  28 days

• Decrease in Inflammatory Markers

  28 days

• Decrease in Inflammatory Markers

  28 days

• Hospitalization within 28 days

  28 days

Study Arms (2)

Standard of Care

NO INTERVENTION

Patient will receive standard of care therapy.

Treatment Arm

ACTIVE COMPARATOR

Patient will receive convalescent plasma

Biological: CCP

Interventions

CCP BIOLOGICAL

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

Also known as: convalescent plasma

Treatment Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Metro Infectious Disease Consultants: lead

Study Sites (1)

Metro Infectious Disease Consultants

Burr Ridge, Illinois, 60527, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Outpatient open label randomized study

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 18, 2020
• Study Start: August 12, 2020
• Primary Completion: August 12, 2020
• Study Completion: August 12, 2021
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)