Covid-19 Living Data

Trial NCT04349592
Publication Q-PROTECT - Omrani A, EClinicalMedicine (2020) (published paper)
Dates: 2020-04-13 to 2020-08-01
Funding: Public/non profit (Hamad Medical Corporation (government health service of the State of Qatar))
Conflict of interest: No

Methods
	RCT Blinding:
	Location : Multicenter / Qatar Follow-up duration (days): 21
Inclusion criteria	Positive Covid test (PCR) used during routine care (i.e. not as part of Q-PROTECT) Patient is in HMC facility for Covid-positive quarantine patients of low acuity (i.e. not requiring hospitalization or antiviral therapy by current Ministry of Public Health guidelines) most cases are anticipated to be healthy young expatriates who cannot be home-quarantined Age at least 18
Exclusion criteria	Treating physician judges patient not appropriate for study participation for any reason Known retinal disease or macular degeneration Psoriasis On tamoxifen for breast cancer Age <18 Breastfeeding or pregnancy (patient-reported pregnancy status is sufficient) Hypersensitivity to chloroquine or HC or AZ History of or known QT prolongation EKG required before study entry and on each visit during the subject’s first seven days on protocol, during the time period HC is being taken Baseline QTc >480 if QRS width normal QTc >510 if QRS >120 Known G6PD deficiency, porphyria, or retinopathy Known hepatic or renal impairment/disease (or abnormality on liver/renal testing at study day 1) Low magnesium or low potassium (by testing on day 1) Current (pre-study) therapy with antimalarial or dapsone Current (pre-study) therapy with antiviral agents (e.g. oseltamivir) Tisdale38 score exceeding 6 as tallied below (based on ACC recommendations)
Interventions
	Treatment HCQ+AZM Hydroxychloroquine: 200 mg orally 3 times a day for 7 days. Azithromycin: 500 mg orally on day 1 followed by 250 mg orally once a day for the next 4 days. Hydroxychloroquine 200 mg orally 3 times a day for 7 days
	Control Placebo
Participants
	Randomized participants : HCQ+AZM=152 Hydroxychloroquine=152 Placebo=152
	Characteristics of participants N= 456 Mean age : NR 449 males Severity : Mild: n= 456/ Asymptomatic: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Proportion of virologically cured (PCR-negative status) as assessed on day six [ Time Frame: Day 6 ]
	In the report Virologic cure (PCR-negative status) as assessed on day six.
Documents available	Protocol Yes. In English Statistical plan NR Data-sharing willing stated in the publication:
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the published article, the trial registry and study protocol were used for data extraction and assessment of risk of bias. No statistical analysis plan was available. There were no substantive differences between the published article, the current trial registration and the study protocol in terms of procedures, population or treatments. The trial registry was changed near to end of recruitment to include outcomes not included in the original entry and the study protocol is not dated, but the data extracted are not affected. The study achieved its pre-stated sample size. Although open to both sexes and conducted in Qatar, the study population was overwhelmingly male and no Qataris were included, reflecting the country’s workforce.