Trial CTRI/2020/04/024479
Publication Gupta S, Med J Armed Forces I (2021) (published paper)
Dates: 2020-05-30 to 2020-09-30
Funding: Public/non profit (Command Hospital Airforce)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / India
Follow-up duration (days): *
Inclusion criteria
  • COVID-19–positive based on real time reverse transcription polymerase chain reaction (rRT PCR)
  • symptomatic for the disease for ≤4 days
  • willing to participate in the trial and satisfied at least two of the following four criteria: (i) oxygen saturation (SaO2) less than 95% as measured by digital pulse oximetry, (ii) respiratory rate more than 20/min, (iii) pulse rate more than 90/min or (iv) imaging evidence of lung infection in the form of reticulonodular opacities, ground glass opacities, consolidation or acute respiratory distress syndrome
Exclusion criteria
  • Younger than 14 years
  • asymptomatic
  • mild illness
  • allergic to chloroquine
  • unwilling to give informed consent
  • prolonged QTc interval on ECG
Interventions
Treatment
Hydroxychloroquine
Initial dose: 400 mg orally twice a day on day 1 - Maintenance dose: 400 mg orally once a day on days 2-5.
Control
Standard care

Participants
Randomized
participants :
Hydroxychloroquine=55
Standard care=55
Characteristics of participants
N= 110
Mean age : NR
80 males
Severity : Mild: n=0 / Moderate: n=* / Severe: n=* Critical: n=*
Number of vaccinated participants: NR
Primary outcome
In the register
number of days of hospitalization (discharge)
In the report
number of days of hospitalization till discharge 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
*
General comment This study is pending contact with authors.
In addition to the published paper, the registry was available (dated April 4 2020). Neither protocol nor statistical analysis plan was available. The primary outcome in the article reflected that in the registry. The trial (n = 110) exceeded its target sample size (n = 32). No follow-up time was reported. No outcomes eligible for COVID NMA were reported.