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 Definition of Standard care: Paracetamol, oxygen, fluids (according to assessment), empiric antibiotic (cephalosporins), oseltamivir if needed (75 mg/12 hours for 5 days), and invasive mechanical ventilation with hydrocortisone for severe cases if PaO2 < 60 mmHg, O2 saturation < 90% despite oxygen or noninvasive ventilation, progressive hypercapnia, respiratory acidosis (pH < 7.3), and progressive or refractory septic shock. Duration : 15 days | |
Participants | |
Randomized 194 participants (n1=97 / n2= 97) | |
Characteristics of participants N=194 Mean age : 40.7 114 males Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=* | |
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 stated No |
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. |