A multicenter randomized trial to assess the efficacy of CONvalescent plasma therapy in patients with Invasive COVID-19 and acute respiratory failure treated with mechanical ventilation: the CONFIDENT trial protocol

Table 1 Schedule of the assessments for each patient during the study

Procedures	Visits
	Screening	Inclusion	Treatment phase				Follow-up
	Screening	Day 1	Day 7	Day 14	Day 21	Day 28	ICU Discharge	Day 90	Day 365
Informed consent		x
Eligibility assessment	x	x
Randomisation		x
Medical history		x
Comorbidities
Prior medications
APACHE II score		x
SOFA score		x	x	x	x	x
WHO disease progression scale		x	x				x
CRP		x	x	x	x	x
Viral load (NP or tracheal PCR)		x	x	x	x	x
Clinical frailty scale		x
Concomitant drugs against SARS-CoV-2	x	x	x	x	x	x
Biological findings		x^a	x^b	x^b	x ^b	x^b
24 h-diuresis		x	x	x	x	x
Serum sample for central analysis		x	x			x		x
Mechanical ventilation		x	x	x	x	x
Renal replacement therapy		x	x	x	x	x
Vasoactive drugs		x	x	x	x	x
ECMO		x	x	x	x	x
Nosocomial infections		x	x	x	x	x
Iatrogenic events		x	x	x	x	x
Adverse events & Serious adverse event		x	x	x	x	x
ADL scale		x						x	x
Anxiety-depression scale								x	x
EQ-5D-5L scale		x						x	x

^aHemoglobin, Hematocrit, Platelet count, White blood cells count, Neutrophil, Lymphocyte, PaO2, FiO2, Na, K, urea, creatinine, protein, bilirubin, ferritin, CRP, D-dimers, fibrinogen, LDH, TGO, TGP, CPK
^bCreatinine, platelet count, bilirubin, CRP, WBC count, Ferritin, Lymphocyte count

ISSN: 1471-2466