A randomized, multicentre, open-label phase II proof-of-concept trial investigating the clinical efficacy and safety of the addition of convalescent plasma to the standard of care in patients hospitalized with COVID-19: the Donated Antibodies Working against nCoV (DAWn-Plasma) trial

Table 1 Participant timeline

Day +/− window	Screen	Baseline	Daily until discharge	Within 12 h after randomization*	24–36 h after 1st administration*	6 +/− 2	15 +/− 2	30 +/− 3	Day 90+/− 5
Day +/− window	− 1 or 0	0	Daily until discharge	Within 12 h after randomization*	24–36 h after 1st administration*	6 +/− 2	15 +/− 2	30 +/− 3	Day 90+/− 5
Assessments/procedures
Eligibility
Informed consent	X
Demographics and medical history	X
Review COVID-19 criteria	X
In- and exclusion criteria	X
ABO D typing¹	X
Study intervention
Randomization		X
Administration of Plasma				X	X
Study procedures
Vital signs including SpO2		X	Daily until discharge
Clinical data collection		X	Daily until discharge
Targeted medication review		X	Daily until discharge
Targeted adverse event evaluation when it occurs		X	Daily until discharge
Electrocardiogram (ECG)		X
Evaluation by telephone							X	X	X
Laboratory
CRP, haematology, chemistry, kidney and liver test	X	At clinician’s discretion	At clinician’s discretion
Pregnancy test for females of childbearing potential	X
Viral qPCR (Nasopharyngeal swab)	X					If feasible
Blood for COVID-19 antibody titre testing and immunoparesis (optional) ²	X					X
Quality of life (QoL) scoring³	X							X	X

¹ABO D typing has to be performed twice at two different, independent time points and the two ABO D results have to be identical before the blood institution can release the plasma units. Before randomization, the ABO D typing should be done at least once and the result should be known
²One serum tube of 10 mL and one EDTA tube of 10 mL. This blood is drawn if feasible and in sites that agree to participate
³QoL scoring using the EQ-5D-5L questionnaire. QoL scoring at day+ 30 is optional if the patient is still hospitalized; if the patient is at home at day+ 30, scoring will be done by telephone call

ISSN: 1745-6215