Convalescent plasma for adults with acute COVID-19 respiratory illness (CONCOR-1): study protocol for an international, multicentre, randomized, open-label trial

Table 1 Schedule of patient assessments

			Follow-up
Visit	Screening	Baseline (D1)	D2–D30⁽¹⁾ (or until discharge)	D30⁽²⁾ (if patients discharged⁾⁽¹⁰⁾
Time window (days)				+/− 3 days
Informed consent/assent	X
Verify eligibility criteria	X
Randomization		X
CCP administration ⁽³⁾		X
Demographics		X
Comorbidities		X
COVID-19 history⁽⁴⁾		X
Height and weight		X
Vital signs		X
SpO₂		X	X
FiO₂		X	X
COVID treatments		X	X	X
Hospitalization daily assessment ⁽⁵⁾		X	X
Results of blood tests (done as per clinical need)		X	X⁽⁶⁾
EQ-5D⁽⁷⁾		X		X
Vital status (dead/ alive)			X	X
Adverse event review		X	X	X
Discharge status ⁽⁸⁾				X
Mechanical ventilation since discharge				X
Viral load, cytokines and anti-CoV-2 titres⁽⁹⁾		X	X

⁽¹⁾ Only collected if still hospitalized
⁽²⁾ Phone call if subject is already discharged from the hospital
⁽³⁾ Only for subject randomized to the CCP treatment
⁽⁴⁾ Includes date of first symptoms; description of symptoms and date of diagnostic test
⁽⁵⁾ Mechanical ventilation, ECMO, renal replacement therapy, or myocarditis
⁽⁶⁾ Daily from day 1 to 7, then day 14 ± 3 days
⁽⁷⁾ EQ-5D to be collected on day 30 regardless of hospitalization status
⁽⁸⁾ Discharge or hospital status (admitted, home, local hospital, long-term care facility)
⁽⁹⁾ To be performed using frozen leftover sample or extra tube collected once at baseline and once during follow-up between D2 and D6
⁽¹⁰⁾ For patients still hospitalized at day 30, chart review will be conducted at day 90 to determine whether the patient was discharged or died in hospital between day 30 and day 90 or is still in hospital at day 90

ISSN: 1745-6215