Cancer
Conditions
Interventions
Trade Name: Zithromax
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
CAS Number: 83905-01-5
Current Sponsor code: OnCoVID19
Concentration unit: mg milligram(s)
Con
Sponsors
Med. Univ. Wien
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Histologically confirmed cancer diagnosis - Active disease in need of antineoplastic therapy o treatment may include classical cytostatic agents, molecular targeted therapy, monoclonal antibodies bevacizumab, cetuximab, rituximab and obinutuzumab (either alone or in combination with chemotherapy) and checkpoint inhibitors o treatment may be ongoing or newly started o oral, intravenous or subcutaneous application route is allowed o adjuvant, neoadjuvant or palliative chemotherapy is allowed o the planned treatment duration must be at least 3 months, i.e. 12 weeks - Age = 18 years - Life expectancy of at least 3 months - Adequate renal, cardiac and liver function to tolerate the treatment - Normal QTc (= 450 ms) on ECG - ECOG performance status of =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Active COVID-19 as defined by clinical WHO criteria and a positive PCR for SARS-COV2 - Use of any investigational agent within 28 days prior to study start - Ongoing radiotherapy - A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs - Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomization, congestive heart failure (NYHA III-IV), arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities, and long QT syndrome (QTc interval >450ms). - Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment) - Inadequate kidney function: serum-creatinine >2.0 times upper normal limit - Hepatic dysfunction: total bilirubin >1.5 times upper normal limit (unless due cancer involvement of liver or a known history of Gilbert's disease); ALT >2.5 times upper normal limit (unless due to disease involvement of liver); alkaline phosphatase >2.5 times upper normal limit (unless due to disease involvement of the liver or bone marrow) - Patients with active opportunistic infections - Pregnant or lactating women. Women of childbearing potential must have a negative pregnancy test at screening, pregnancy testing must be performed within 7 days of administration of IMP. Approved methods of birth control must be used - Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. - Inability to swallow tablets/study medication
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Cumulative number of SARS-COV-2 infections as verified by PCR from routine nasal swabs performed every 28 days (symptomatic or asymptomatic) at week 12 after initiation of therapy;Secondary Objective: - To evaluate the capacity of azithromycin to prevent severe COVID-19 infections, defined as a combined endpoint of hospitalization and death in cancer patients undergoing active treatment with chemotherapy - Severity of COVID-19 cases (see grading as defined by the WHO) - All-cause mortality - Safety and tolerability of IMP (clinical and laboratory, CTCAE criteria) - Occurrence of viral or bacterial infections other than COVID-19 - Development of azithromycin-resistant bacterial strains as assessed by nasal swabs ;Primary end point(s): Number of SARS-COV-2 infections (symptomatic or asymptomatic): detected by routine SARS-COV-2 tests in all patients treated at the Division of Oncology, Medical University of Vienna. During the SARSCOV-2 pandemic, the routine approach to patients undergoing chemotherapy at our institution is PCR from nasal swabs taken every 28 days. The cumulative number of infections detected (symptomatic or asymptomatic) at week 8 after initiation of therapy in both treatment arms serves as the primary endpoint.;Timepoint(s) of evaluation of this end point: after 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of patients experiencing severe COVID-19 infection defined as a combined endpoint of hospitalization or death at week 12 after initiation of therapy. COVID-19 cases are defined as outlined by the WHO, including a PCR for COVID-19 from any specimen (respiratory, blood, urine, stool, other bodily fluids). Severity of COVID-19 cases: The severity of cases will be classified as suggested in the Blue Print for COVID-19 therapeutic trials by the WHO (range 0-8);Timepoint(s) of evaluation of this end point: after EOS | — |
Countries
Austria
Contacts
Public ContactMatthias Preusser
Med. Univ. Wien
Outcome results
None listed