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 |
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Control
Standard care Definition of Standard care: All of the participants were also treated with oral Lopinavir/Ritonavir (Kaletra, Abbott Laboratories) 400/100 mg twice daily and daily dose of oral Hydroxychloroquine (400 mg) according to the Iranian COVID-19 treatment protocol at time of this study. Some of the patients deteriorated during the admission and received corticosteroid (methylprednisolone 125 mg daily for three days) and IVIG (5 to 10 gr daily for three to five days). | |
Participants | |
Randomized 60 participants (n1=30 / n2= 30) | |
Characteristics of participants N=60 Mean age : 59.3 30 males Severity : Mild: n=0 / Moderate: n=0/ Severe: n=60 Critical: n=0 | |
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 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 |
* |
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. |