Trial NCT04359537
Publication Syed F, CHEER, 2021

Funding: Private (Getz pharma (HCQ supply))
Conflict of interest:

Methods
RCT
Location : Single cent / Pakistan
Follow-up duration (days): 84
Inclusion criteriaAll healthcare workers at high risk for COVID-19 exposure; primarily those in emergency departments (physicians, nurses, ancillary staff, triage personnel), intensive care units (physicians, nurses, ancillary staff, respiratory therapists), performing aerosol-generating procedures (anesthesiologists, nurse, anesthetists, gastroenterologists performing endoscopy, pulmonologists performing bronchoscopy), first responders (EMTs, paramedics) and those working in the departments of general medicine, pulmonology, infectious disease and isolation wards.
Exclusion criteriaActive COVID-19 cases; those with existing symptoms like fever, cough, shortness of breath; having prior retinal eye disease; Chronic Kidney Disease (CKD), Stage 4 or 5 or dialysis; Glucose-6 Phosphate Dehydrogenase (G-6-PD) deficiency; recent Myocardial Infarction (MI); epileptic; pregnant females; subjects weighing < 40 kg; having contraindication or allergy to chloroquine/ HCQ; already administering HCQ or cardiac medicines like flecainide, amiodarone, digoxin, procainamide, or propafenone, medications with known significant drug-drug interactions like artemether, lumefantrine, mefloquine, tamoxifen or methotrexate and those causing QT interval prolongation like macrolides, antipsychotics, quinolones, antihistamines, SSRIs, tricyclic antidepressants, antifungals.
Interventions
Treatment 1
Hydroxychloroquine 400 mg* qweek
Control
Placebo
Treatment 3
Hydroxychloroquine 400 mg q3week
Treatment 4
Hydroxychloroquine 200 mg q3week
Participants
Randomized
200 participants n1=48/ n2=46/ n3=51n4=55
Characteristics of participants
N=200
Mean age : 30.6
109 males
Primary outcome
In the register
COVID-19-free survival in experimental arms compared to placebo [ Time Frame: 12 weeks ]
In the report
Documents
available

Protocol

No

Statistical plan

No

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 pre-print article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither study protocol nor statistical analysis plan was available. There were no substantive differences between the prospective registry and the pre-print article in population, procedures, interventions or outcomes. The study achieved its prespecified target sample size.