International Sites: Novel Experimental COVID-19 Therapies Affecting Host Response (NECTAR)
COVID-19, SARS-CoV2 Infection, Coronavirus Infection
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Hospitalized for COVID-19
- ≥18 years of age
SARS-CoV-2 infection, documented by:
- nucleic acid test (NAT) or equivalent testing within 3 days prior to randomization OR
- documented by NAT or equivalent testing more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non- NAT tests is maintained in Appendix E. Appendix E. Non-NAT Tests Deemed with Equivalent Specificity to NAT by the Protocol Team).
- Hypoxemia, defined as SpO2 <92% on room air, new receipt of supplemental oxygen to maintain SpO2 ≥92%, or increased supplemental oxygen to maintain SpO2 ≥92% for a patient on chronic oxygen therapy
Symptoms or signs of acute COVID-19, defined as one or more of the following:
- cough
- reported or documented body temperature of 100.4 degrees Fahrenheit or greater
- shortness of breath
- chest pain
- infiltrates on chest imaging (x-ray, CT scan, lung ultrasound)
Exclusion Criteria:
- Onset of COVID-19 symptom fulfilling inclusion criterion #5 >14 days prior to randomization
- Hospitalized with hypoxemia (as defined in inclusion #4) for >72 hours prior to randomization (the 72-hour window for randomization begins when the patient first meets the hypoxemia inclusion criteria after hospital admission)
- Pregnancy
- Breastfeeding
- Prisoners
- End-stage renal disease (ESRD) on dialysis
- Patient undergoing comfort care measures only such that treatment focuses on end-of- life symptom management over prolongation of life.
- The treating clinician expects inability to participate in study procedures or participation would not be in the best interests of the patient
- Known allergy/hypersensitivity to IMP or its excipients
Fostamatinib Arm-Specific Exclusion Criteria:
The following exclusion criteria differ from the master protocol criteria:
1. Randomized in another trial evaluating fostamatinib in the prior 30 days
Study arm exclusion criteria measured within 24 hours prior to randomization:
- AST or ALT ≥ 5 × upper limit of normal (ULN) or ALT or AST ≥ 3 × ULN and total bilirubin ≥ 2 × ULN
- SBP > 160 mmHg or DBP > 100 mmHg at the time of screening and randomization
- ANC < 1000/mL
- Patient is anticipated to require a strong CYP3A inhibitor (Atazanavir, Certinib, Clarithromycin, Cobicistat and cobicistat-containing coformulations, Idelalisib,Indinavir, Itraconazole, Ketoconazole, Levoketoconazole, Lonafarnib, Lopinavir, Mifeprostone, Mibefradil, Nefazodone, Nelfinavir, Ombitasvir-paritaprevir-ritonavir plus dasabuvir, Posaconazole, Ribociclib Ritonavir, Saquinavir, Telithromycin, Troleandomycin, Tucatinib, Voriconazole) from randomization to 21 days post-randomization. For a full list of CYP3A4 substrates, please reference this regularly updated list: https://drug-interactions.medicine.iu.edu/MainTable.aspx.
- Patient unable to participate or declines participation in the fostamatinib arm.
Sites / Locations
- Hospital de Clínicas de Porto Alegre
- Hospital Federal dos Servidores do Estado
- Instituto Nacional de Infectologia Evandro Chagas
- University Hospital Bonn
- University of Frankfurt
- Ente Ospedaliero Ospedali Galliera
- San Paolo Hospital - ASST Santi Paolo e Carlo
- San Raffaele Turro Hospital
- University of Milan
- Worthwhile Clinical Trials (WWCT Lakeview Hospital)
- Clinical HIV Research Unit - Helen Joseph Hospital (WITS CHRU)
- Global Clinical Trials (Pty) Ltd
- Hospital Clinic Barcelona
- Hospital General Universitario de Elche
- Hospital del Mar
- Hospital Universitario Vall d'Hebron
- Hospital Clinico San Carlos
- Hospital Universitario Fundacion Alcorcon
- Hospital Universitario Ramón y Cajal
- Universidad de Valladolid - Hospital Universitario Río Hortega
- Hospital Clinico Universitario Lozano Blesa
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Fostamatinib
Placebo
An investigational oral spleen tyrosine kinase inhibitor.
Orange film-coated, plain, bioconvex tablets for fostamatinib. For the purposes of interim and final analyses, the route and frequency of placebo will be ignored, and all placebo participants will be pooled together as a single group. In comparing an active drug versus placebo, only those placebo participants that were eligible for the active drug will be included.