NCT04438057.

Trial design: randomised 2:1 (CP:standard of care)

Sample size: 150

Setting: mild to moderate symptoms

Country: USA

Language: English

Number of centres: 1

Trial registration number: NCT04438057

Date of registration:  18 June 2020

Inclusion criteria:

• Laboratory‐confirmed diagnosis of infection with SARS‐CoV‐2

• Symptoms of COVID ‐19 ‐ cough, fever, sore throat, shortness of breath, anosmia, diarrhoea, myalgia

• Symptoms < 14 days

• ID physician determination that the patient does not need hospitalisation

• 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 years

• Patients currently receiving intravenous immunoglobulin

• Hypercoagulable state ‐ neoplasia, collagen vascular disease, myelodysplastic syndrome, chronic anticoagulation treatment, etc

• Need to be hospitalised

• O2 sat < 93%

• D‐Dimer > 2 x 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

• Enrolment 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 breastfeeding

• 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

Donor eligibility criteria: NR

Donor exclusion criteria: NR

Intervention(s): CP therapy (arm 1: 1 dose, arm 2: 2 doses)

Details of CP:

• Type of plasma: CP

• Volume: NR

• Number of doses: 1

• Antibody test and antibody‐titre: NR

• Pathogen inactivated or not: NR

• RT‐PCR tested: NR

Details of donors: 

• Gender: NR

• HLA and HNA antibody: NR

• Severity of disease: NR

• Timing from recovery from disease: NR

Treatment details, including time of plasma therapy (e.g. early stage of disease): mild to moderate symptoms  

Comparator: standard of care

Concomitant therapy: standard of care 

Duration of follow‐up: 28 days

Treatment cross‐overs: nil

Primary study outcome: 

• Time to resolution of symptoms (time frame: 28 days)

• SAEs within 24 h of plasma infusion (time frame: 28 days)

Primary review outcomes reported

• All‐cause mortality: NR

• Admission to hospital: yes (28 days)

Secondary review outcomes reported

• Development of severe clinical COVID‐19 symptoms, defined as WHO Clinical Progression Scale ≥ 6 (WHO 2020e): NR

• Time to symptom onset: NR

• Clinical status, assessed by need for respiratory support with standardised scales (e.g. WHO Clinical Progression Scale, WHO Ordinal Scale for Clinical Improvement) at up to 7 days, 8 to 15 days, 16 to 30 days: NR

• Mortality (time to event): NR

• 90‐day mortality: NR

• Length of hospital stay, for hospitalised patients: NR

• Admission to the intensive care unit (ICU): NR

• Viral clearance, assessed with RT‐PCR test: NR

• QoL: NR

• Number of participants with grade 3 and grade 4 adverse events, including potential relationship between intervention and adverse reaction (e.g. TRALI, TACO, TAD, acute transfusion reactions): NR

• Number of participants with serious adverse events: NR (severe adverse effects of CP only, 24 hours after infusion)

Additional outcomes:

• Laboratory parameters (CRP, D‐dimer, LDH, Ferritin, Lactate Dehydrogenase)

Contact: Nicholas Van Hise, PharmD    630‐655‐6952    nvanhise@midcusa.com   

Contact: Nathan Skorodin, PharmD       nskorodin@midcusa.com   

Recruitment status: recruiting 

Prospective completion date: August 12, 2021

Sponsor/funding: Metro Infectious Disease Consultants