Trial NCT04349592
Publication Omrani A, Q-PROTECT, 2020 (published paper)
Dates: 4/13/2020 to 8/1/2020
Funding: Public/non profit (Hamad Medical Corporation (government health service of the State of Qatar))
Conflict of interest: No

Methods
RCT
Blinding: triple blinding
Location : Multicenter / Qatar
Follow-up duration (days): 21
Inclusion criteriaPositive 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 criteriaTreating 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 1
Hydroxychloroquine+Azithromycin (200 mg/250 mg)
Duration : 7 days
Control
Placebo
Control
Hydroxychloroquine (200 mg)
Duration : 7 days
Participants
Randomized
456 participants n1=152/ n2=152/ n3=152
Characteristics of participants
N=456
Mean age : NR
449 males
Severity : Mild: n=0 / Moderate: n=0/ Severe: n=0 Critical: n=0
Primary outcome
In the register
Proportion of virologically cured (PCR-negative status) as assessed on day six [ Time Frame: Day 6 ]
In the report
NR
Documents
avalaible

Protocol

Yes. In English

Statistical plan

NR

Data-sharing stated

Yes
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.