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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04438057
• Other study ID #: MIDC-CCP
• Status: Completed
• Phase: Phase 2
• Start date: August 12, 2020
• Est. completion date: August 12, 2021

Study information

• Verified date: April 2022
• Source: Metro Infectious Disease Consultants
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
United States	Metro Infectious Disease Consultants	Burr Ridge	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Metro Infectious Disease Consultants

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	SAEs within 24 hours of plasma infusion		28 days
Secondary	Decrease in Inflammatory Markers	A 50% decrease at day 28 in C-Reactive Protein (mg/mL)	28 days
Secondary	Decrease in Inflammatory Markers	A 50% decrease at day 28 in D-Dimer (ng/mL)	28 days
Secondary	Decrease in Inflammatory Markers	A 50% decrease at day 28 in Ferritin (ng/mL)	28 days
Secondary	Decrease in Inflammatory Markers	A 50% decrease at day 28 in Lactate Dehydrogenase (U/L)	28 days
Secondary	Hospitalization within 28 days		28 days