Trial NCT04579393
Publication Strich JR, Clin Infect Dis, 2021 (published paper)
Dates: 2020-10-08 to 2021-03-02
Funding: Mixed (Division of Intramural Research (DIR) of the National Heart, Lung and Blood Institute of the US National Institutes of Health, which has a research collaboration with Rigel Pharmaceuticals, Inc through a Cooperative Research and Development Agreement (CRADA). Study drug and matching placebo were provided by Rigel Pharmaceuticals, Inc.)
Conflict of interest: No
| Methods | |
| RCT Blinding: double blinding | |
| Location :
Multicenter / USA Follow-up duration (days): 28 | |
| Inclusion criteria | 1) Patient must be hospitalized, or had their inpatient stay extended, for COVID-19; 2) Age ≥18 years; 3) informed consent prior to initiation of any study procedures; 4) agrees to comply with planned study procedures; 5) Females of childbearing potential must agree to be abstinent or use a medical acceptable form of contraception from the time of enrollment through 30 days after last day of study drug; 6) Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment; 7) Illness of any duration with SpO2 of less than 94% on room air requiring supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or mechanical ventilation or ECMO (5 to 7 on the 8-point scale) |
| Exclusion criteria | 1) ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST ≥ 3 ULN and total bilirubin > 2 ULN; 2) Estimated glomerular filtration rate (eGFR) <30ml/min; 3) Pregnancy or breast feeding; 4) Anticipated discharge in the next 72 hours; 5) Allergy to study medication; 6) Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood pressure >100mmHg); 7) Shock or hypotension at the time of enrollment; 8) Neutrophil count <1000/µL; 9) Concern for bacterial or fungal sepsis; 10) Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton’s tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting biologic therapy (anti-TNF, IL-6); 11) Received a live vaccine the last 4 weeks; 12) cognitively impaired or mentally disabled prior to COVID diagnosis; 13) Participation in another clinical trial for the treatment of COVID-19. |
| Interventions | |
| Treatment
Placebo * |
|
| Control
Fostamatinib ( / ) | |
| Participants | |
| Randomized 59 participants (n1=29 / n2= 30) | |
| Characteristics of participants N=59 Mean age : 55.6 47 males Severity : Mild: n=0 / Moderate: n=23/ Severe: n=32 Critical: n=4 | |
| Primary outcome | |
| In the register Cumulative Incidence of SAEs [ Time Frame: Day 29 ] | |
| In the report Cumulative incidence of serious adverse events (SAE) through day 29 | |
| Documents available |
Protocol NR Statistical plan NR 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 |
Low |
| General comment | In addition to the published article, the prospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The trial (n = 59) did not achieve its target sample size. The primary and secondary outcomes in the article reflect those in the registry. There is no change from the trial registration in the intervention and control treatments. |