Trial *
Publication Arshad S, Int J Infect Dis, 2020
Dates: 3/10/2020 to 5/2/2020
| Methods | |
| Non-randomized study | |
| Location :
Multicenter / USA Follow-up duration (days): 28.5 | |
| Inclusion criteria | Patients with a COVID-related admission in the health system from March 10, 2020 to May 2, 2020 were included. Only the first admission was included for patients with multiple admissions. All patients were hospitalized though our emergency department. A COVID-related admission was defined as hospitalization during which the patient had a positive SARS-CoV-2 test. Diagnosis with SARS-CoV-2 was confirmed by a positive reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay from a nasopharyngeal sample. All patients evaluated were 18 years of age and older and were treated as inpatients for at least 48 hours unless they expired within the time period. |
| Exclusion criteria | There was a total of 2,948 COVID-19 admissions, of these, 267 (9%) patients had not been discharged, 15 (0.5%) left against medical advice, and four (0.1%) were transferred to another healthcare facility; these patients were excluded from analysis as we could not ascertain their outcome. In addition, there were 121 (4.1%) readmissions, which were also excluded. |
| Type of analysis | Multivariable Cox Regression |
| Interventions | |
| Treatment
Hydroxychloroquine (400mg on day 1, followed by 200 mg on days 2-5) Co-Intervention: Standard Care Duration : 5 days |
|
| Control
Standard Care | |
| Participants | |
| N analyzed 1611 participants (n1=1202 / n2= 409) | |
| Characteristics of participants N=2541 Mean age : 63.7 1298 males Severity : Mild: n=0 / Moderate: n=*/ Severe: n=* Critical: n=448 | |
| Primary outcome | |
| In the register NR | |
| In the report The primary endpoint was in-patient hospital mortality in each treatment group. | |
| Documents avalaible |
Protocol NR Statistical plan NR Data-sharing stated NR |
| 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 |
Serious |
| Notes | This is a non-randomized study. The published journal pre-proof was used in data extraction and risk of bias assessment. No study registry, protocol or statistical analysis plan were available. A multivariable Cox regression model was used to adjust for confounding and analyze the data of the 4 arms to give HR Time to death. A propensity score matched sample and analysis between intervention groups HCQ vs control group SC was also reported for the outcome, time to death. Insurance was not a confounder that was controlled for, which is a confounder of interest in a study in the USA since there is no universal healthcare. |