Trial NCT04447534
Publication Abd-Elsalam S, Biol Trace Elem Res (2020) (published paper)
Dates: 2020-06-23 to 2020-08-23
Funding: Not reported/unclear
Conflict of interest: No

Methods
RCT
Blinding:
Location : Multicenter / Egypt
Follow-up duration (days): 28
Inclusion criteria
  • Patients with with a confirmed diagnosis of COVID-19 infection by real-time PCR test
Exclusion criteria
  • Report: Patient with hypokalemia or hypomagnesemia, porphyria, neutrophilia, myasthenia gravis, maculopathy or changes in the visual field, heart failure, prolonged QT interval in ECG, liver cirrhosis, psoriasis, epilepsy, anemia from pyruvate kinase and G6PD deficiencies, chronic kidney disease, and pregnant or lactating females.

    Registry: Contraindications or hypersensitivity to chloroquine
Interventions
Treatment
Hydroxychloroquine+Zinc
Control
Hydroxychloroquine


Participants
Randomized
participants :
Hydroxychloroquine+Zinc=96
Hydroxychloroquine=95
Characteristics of participants
N= 191
Mean age : NR
116 males
Severity : Mild: n=21 / Moderate: n=113 / Severe: n=38 Critical: n=19
Number of vaccinated participants: NR
Primary outcome
In the register
Number of patients with improvement or mortality [ Time Frame: 2 weeks ]
In the report
Recovery within 28 days, need for mechanical ventilation, and 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 trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The registry indicates that the trial was randomized and double blinded (participant and care provider) but no details are provided in the report on the measures were taken to establish and maintain blinding such as a placebo for zinc in the control group. There is no change from the trial registration in the intervention and control treatments however doses and frequency were not reported in the trial registration. There were some differences between exclusion criteria and follow up duration between the trial registry and the published article.