Trial NCT04353336
Publication Abd-Elsalam S, Am J Trop Med Hyg (2020) (published paper)
Dates: 2020-03-23 to 2020-06-30
Funding: Public/non profit (Tanta University)
Conflict of interest: *

Methods
RCT
Blinding: Unblinded
Location : Multicenter / Egypt
Follow-up duration (days): 28
Inclusion criteria
  • 1) All patients admitted with SARS-CoV-2 infection
    2) Enrolled both genders
Exclusion criteria
  • 1) Patient who had allergy or contraindication to HCQ
    2) Pregnant and lactating females
    3) Patients with cardiac problem (chronic heart failure or prolonged QT interval on electrocardiogram [ECG])
Interventions
Treatment
Hydroxychloroquine
Initial dose: 400 mg orally twice daily on day 1, maintenance dose: 200 mg orally twice daily for 15 days
Control
Standard care

Participants
Randomized
participants :
Hydroxychloroquine=97
Standard care=97
Characteristics of participants
N= 194
Mean age : NR
114 males
Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
Number of patients with cure or death [Time Frame: 1 month]
In the report
Recovery within 28 days, need for mechanical ventilation, or death.
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

Not reported
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 study registry was used in data extraction and assessment of risk of bias. Neither the study protocol nor the statistical analysis plan was available. The study was retrospectively registered. There is no change from the trial registration in the intervention and control treatments. It is not clear how many patients received which aspects of standard care. Several outcomes are reported in the manuscript that are not included in the registry.