Table 1.

Schedule of enrolment, interventions and assessments from SPIRIT checklist

Study Visitsi	Screen	Baseline	WK4	WK10 Telephone	WK16	WK 22 Telephone	WK28	WK 34 Telephone	WK40	WK44	WK48	WK52 End of study treatment	Follow up WK56	Withdrawalii
Visit Number	1	2	3	-	4	-	5	-	6	7	8	9	10	-
Day (Visit window)	Up to 28 days	0	28 (± 7)	70 (± 7)	112 (± 7)	154 (± 7)	196 (± 7)	238 (± 7)	280 (± 7)	308 (± 7)	336 (± 7)	364 (± 7)	392 (± 7)
Patient information and informed consent	X
Interventions:
IMP dispensing		X	X		X		X		X
IMP dose recording / review of patient diary			X		X		X		X	X	X	X		X
Prednisolone dose recording	X	X	X		X		X		X	X	X	X	X	X
Assessments:
COVID symptom assessment	X	X	X		X		X		X	X	X	X	X	X
Eye screen												Xiii
Eligibility	X	Xiv
Randomisation		X
Medical history, Demographics	X
Physical exam, Weight, Vital signsv, Urine dipstick	X	X	X		X		X		X	X	X	X	X	X
ECG	X				X
Medications	X	X	X	X	X	X	X	X	X	X	X	X	X	X
BVASvi	X	X	X		X		X		X	X	X	X	X	X
VDI		X			X		X			X		X
GTI		X					X					X
Physician’s Global Assessment	X	X	X		X		X		X	X	X	X	X	X
Urine drug screen	X
SF-36, EQ5D, HAQ, AAV Pro		X		Xvii	X	Xvii	X	Xvii		X		X	X	X
FACIT score		X			X		X			X		X	X	X
Adverse event reporting		X	X	X	X	X	X	X	X	X	X	X	X	X
Clinical Labs:
ANCA	X				X		X		X			X	X	X
ESRviii, CRP		X			X		X		X			X	X	X
Glucose		X			X		X		X			X	X	X
HbA1C	X						X					X
Lipids	X						X					X
Renal profile including creatinine and eGFRix	X	X	X		X		X		X			X	X	X
Full blood count	X	Xx	X		X		X		X			X	X	X
Liver function tests	X	Xx	X		X		X		X			X	X	X
Protein: creatinine ratioxi	X	X	X		X		X		X	X	X	X	X	X
Viral screenxii	X
Pregnancy testxiii	X	X
Research Blood Specimens:
Hydroxychloroquine levels		X			X		X					X
Plasma, Serum and Cellsxiv		X			X		X		X			X		Xxv

ⁱ Patients will be followed up by telephone at weeks 10, 22 and 34 rather than visiting the study centre. The phone call will be structured using the AAV pro questionnaire. See section 6.13 for more details

ⁱⁱ To be arranged if a patient withdraws from the trial but is willing to have a final study visit. This is only necessary in instances where the patient’s last visit was more than 4 weeks ago

ⁱⁱⁱ The eye screen is only required for patients whose eGFR drops below 60ml/min at any point during the trial. The eye screen should take place between week 52 and week 56 visits by a local optometrist

^iv The eligibility criteria require BVAS to be scored and for female patients to have a pregnancy test at baseline as well as screening. Other screening procedures do not need to be repeated

^v Vital signs to include BP, pulse, respiration rate and temperature

^vi BVAS and VDI to be scored locally following training. BVAS scores will be quality checked by a central adjudication panel to ensure consistency

^vii Telephone follow up interviews will only use the AAV Pro questionnaire to structure the conversation. The SF-36, EQ5D and HAQ questionnaires will not be included

^viii Where ESR is not available, plasma viscosity may be used instead

^ix If the patient’s eGFR drops below 60ml/min at any point of the trial they should be invited for an eye screen between week 52 and 56

^x If the baseline visit is less than two weeks after screening, these tests do not need to be performed again

^xi Protein:creatinine ratio only needs to be performed if urine dipstick for protein shows 1+ or more, but results can be collected if routinely performed when the urine dipstick is negative

^xii Patients who test positive for hepatitis B surface antigen, hepatitis B core antibody, hepatitis C antibody or HIV-1 will be excluded

^xiii Urine pregnancy test

^xiv Plasma and serum collected at all sites. Cells at Guy’s Hospital only

^xv Samples only collected if the patient is identified as having a flare