A multi-centre, randomized, double-blind, placebo-controlled clinical trial of the efficacy and safety of chloroquine phosphate, hydroxychloroquine sulphate and lopinavir/ritonavir for the treatment of COVID-19 in Lagos State: study protocol for a randomized controlled trial

Table 4 Schedule of assessments

Study period	Screening	Baseline	Follow-up days
Day ± window	−1 or 1	1	2	3	4	5	6	7	8	9	10	11–14	15 ± 2	29 ± 3
1. Eligibility
Informed consent	X
Demographics and medical history	X
Lung auscultation	X
Chest radiography	X
Confirm SARS-CoV-2 results¹	X
2. Study interventions
Randomization		X
Administration of study drugs²		X	X	X	X	X	X	X	X	X	X	X
3. Study procedures
Vital signs		X	X	X	X	X	X	X	X	X	X	X	X
Clinical assessment³		X	X	X	X	X	X	X	X	X	X	X	X
Review treatment/management		X	X	X	X	X	X	X	X	X	X	X	X	X
ECG for safety		X		X		X			X			X	X	X
Adverse event evaluation		X	X	X	X	X	X	X	X	X	X	X	X	X
4. Laboratory tests for safety
Full blood count, liver function tests, creatinine⁴		X							X				X
Pregnancy test for women of reproductive age	X
5. SARS-CoV-2 testing
PCR for SARS-CoV-2		X		X		X			X			X	X	X
6. Sample for future testing
Oropharyngeal swabs⁵		X							X				X
Blood/serum⁵		X							X				X

¹Time frame for test results: Results of tests done within 72 h of enrolment will be used
²Treatment duration: If the patient is still on admission after day 14, standard treatment will continue in all arms of the study while study medications stop on day 7 for chloroquine and hydroxychloroquine and on day 14 for lopinavir/ritonavir
³Clinical data to be collected: See the “Efficacy assessments” section for details
⁴Laboratory tests for safety: Blood—haemoglobin, white cell count, platelets, glucose, creatinine, bilirubin, alanine aminotransferase, aspartate aminotransferase
⁵Samples for future research: To be used when additional SARS-CoV-2 tests become available

ISSN: 1745-6215