Trial NCT04321096 ; EudraCT Number: 2020001,20042
Publication Gunst J, EClinicalMedicine, 2021 (published paper)
Dates: 2020-04-04 to 2020-12-31
Funding: Private (The Lundbeck Foundation)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: | |
| Location :
Multicenter / Denmark, Sweden Follow-up duration (days): 30 | |
| Inclusion criteria | Symptomatic Covid-19 infection ; PCR-positive for SARS-CoV-2 in respiratory tract samples ; hospital admission for ≤ 48 h. |
| Exclusion criteria | Serum total bilirubin ≥ 3 upper limit of normal range ; estimated glomerular filtration rate (eGFR) ≤30 mL/min ; pregnancy or breastfeeding ; unable to understand or sign the informed consent form (e.g. those requiring invasive mechanical ventilation at study entry). |
| Interventions | |
| Treatment
Camostat Mesilate 200 mg three times a day for five days. |
|
| Control
Placebo | |
| Participants | |
| Randomized 208 participants (n1=139 / n2= 69) | |
| Characteristics of participants N=208 Mean age : NR 123 males Severity : Mild: n=69 / Moderate: n=120/ Severe: n=16 Critical: n=0 | |
| Primary outcome | |
| In the register Clinical improvement defined as live hospital discharge OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale. | |
| In the report Time to clinical improvement, defined as live hospital discharge or an improvement of at least 2 points from baseline on the 7-point ordinal scale, which ever came first | |
| Documents available |
Protocol Yes. In English Statistical plan Yes Data-sharing stated
|
| 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, protocol, statistical analysis plan (in the protocol) and supplementary files were used in data extraction and assessment of risk of bias. There were no substantive differences in population, procedures, or interventions between the published article and the trial registry, protocol and statistical analysis plan. The outcome 'Days in ICU' was specified in the trial protocol but not in the trial registry nor in the published paper. The article reports the inpatient part of a two-part trial that has two cohorts: one inpatients, one outpatients. The study achieved its pre-specified target sample size. |