Trial IRCT20200411047025N1
Publication JamaliMoghadamSiahkali S, Eur J Med Res (2021) (published paper)
Dates: 2020-04-01 to 2020-05-30
Funding: Public/non profit (Tehran University of Medical Sciences)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): *
Inclusion criteria
  • Age older than 18 years

  • Positive COVID-19 polymerase chain reaction (PCR) test or COVID-19 suspicion based on clinical findings (mainly fever, dyspnea, dry cough)

  • Imaging findings of COVID-19 on spiral chest computer tomography (CT) or high resolution CT (HRCT) imagings validated by a trained radiologist

  • Clinical manifestations of ARDS or myocarditis
  • and oxygen saturation lower than 93% from admission or after 48 hours from the first COVID-19 treatment
Exclusion criteria
  • Receiving anti-retroviral therapy or immune system booster medications in the last three months

  • No proven and confirmed COVID-19 disease based on the inclusion criteria

  • Patients with Glucose-6-phosphate dehydrogenase (G6PD) deficiency

  • Patients with end stage renal diseases (ESRD)

  • Pregnancy
Interventions
Treatment
Vitamin C
1.5 g IV four times daily for 5 days
Control
Standard care

Participants
Randomized
participants :
Vitamin C=30
Standard care=30
Characteristics of participants
N= 60
Mean age : NR
30 males
Severity : Mild: n=0 / Moderate: n=0 / Severe: n=60 Critical: n=0
Number of vaccinated participants: NR
Primary outcome
In the register
improvement of SPO2 (stands for peripheral capillary oxygen saturation); daily, until 3-5 days or discharge
In the report
The primary endpoints in this trial were a decrease in mortality, duration of hospitalization, and need for ICU admission
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing willing stated in the publication:

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
*
General comment This study is pending contact with authors due to lack of information on outcome timepoints, and overall follow-up.

In addition to the pre-print article, the trial registry was used in data extraction and risk of bias assessment. Neither study protocol nor statistical analysis plan was available. There were some differences between the trial registry and the pre-print article in terms of population, with the inclusion criteria in the pre-print article limiting recruitment to those with more severe COVID and respiratory distress. Several outcomes reported in the pre-print article were not included in the registry (length of hospital stay, length of ICU admission, death and intubation). The target sample size specified in the registry was not achieved. It is unclear if the study was registered prior to starting recruitment. There is no change from the trial registration in the intervention and control treatments. The mortality outcome reported was not found in the study registry. Adverse events were reported only in the intervention group.