Trial NCT04349592
Publication Omrani A (Q-PROTECT), EClinicalMedicine, 2020 (Triple blinding)
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: Published paper | |
| 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 subjectâs 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) Co-Intervention: NA Duration : 7 days | |
| Control Placebo (NA/NA) Co-Intervention: NA Duration : 7 days | |
| Treatment 3 Hydroxychloroquine (200 mg/NA) Co-Intervention: NA 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=456 / 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 Virologic cure (PCR-negative status) as assessed on day six. | |
| Documents avalaible |
Protocol Yes. In English Statistical plan NA 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 countryâs workforce. |