Trial NCT04682873
Publication Holubovska O, medRxiv, 2021 (preprint)
Funding: Mixed (Wellcome Trust and Royal Society ; National Institutes of Health ; Farmak Public Joint Stock Company, Kiev, Ukraine.)
Conflict of interest: Yes
| Methods | |
| RCT Blinding: quadruple blinding | |
| Location :
Multicenter / Ukraine Follow-up duration (days): 29 | |
| Inclusion criteria | Willing and able to provide written informed consent; Aged ≥ 18 years; SARS-CoV-2 infection confirmed by PCR ≤ 4 days before randomization; Currently hospitalized due to SARS-CoV-2 infection with fever, defined as body temperature ≥ 37.8 °C; Modified World Health Organization (WHO) Ordinal Scale for Clinical Status Patient state in Covid-19: score 4 i.e. hospitalized, virus-positive, oxygen by mask or nasal prongs. |
| Exclusion criteria | Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to start of IMP treatment; Requiring mechanical ventilation at screening or it is expected within 24 h after inclusion; Expected survival time < 72 hours for any reason; Positive pregnancy test; Breastfeeding woman; Presence of renal dysfunction defined as estimated glomerular filtration rate (eGFR) <60 mL/min, total bilirubin ≥ 2.0 mg/dL, Thyroid stimulating hormone (TSH) outside normal range and / or Aspartate aminotransferase (ASAT)/ Alanine aminotransferase (ALAT) above threefold upper limit of normal range (known from patients medical history); Known hypersensitivity to the trial drug, the metabolites, or formulation excipient; History or presence of drug or alcohol abuse; History or presence of diseases of thyroid gland |
| Interventions | |
| Treatment
Enisamium 500 mg every 6 hours for 168 hours |
|
| Control
Placebo | |
| Participants | |
| Randomized * participants (n1=* / n2= *) | |
| Characteristics of participants N=* Mean age : NR * males Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0 | |
| Primary outcome | |
| In the register Time from day of randomization to an increase of at least two points (from the status at randomization) on the following severity rating (SR) scale in days [Time Frame: Day 0 to Day 29]: 1 Death; 2 Hospitalized, on invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); 3 Hospitalized, on non-invasive ventilation or high flow oxygen devices; 4 Hospitalized, requiring supplemental oxygen; 5 Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (Covid-19 related or otherwise); 6 Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care; 7 Not hospitalized, limitation on activities and/or requiring home oxygen; 8 Not hospitalized, no limitations on activities | |
| In the report The chosen primary endpoint of the trial was time-to-recovery, and recovery was defined as an improvement in the SR baseline status by 2 SR score values | |
| 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 |
Some concerns |
| General comment |
This study is pending contact with authors. No review-specific outcomes were extracted.
In addition to the pre-print article, the trial registry and supplementary materials were used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. There were substantial differences between the outcomes in the registry and the pre-print article. Only one of multiple outcomes in the trial registry was reported, but could not be extracted. Numbers of patients in each treatment group were not reported. Interim analysis of an ongoing study. |