COVID-19 trials registries data warehouse

https://www.clinicaltrialsregister.eu/ctr-search/trial/2020-001327-13/AT

Med. Univ. Wien - Matthias Preusser

mattias.preusser@meduniwien.ac.at

2020-03-30

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

- 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 < 3 - Negative PCR for SARS-COV-2 not older than 28 days - Capable of understanding the study and giving informed consent

- 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

2

Med. Univ. Wien

18

None

Austria

High risk patients

N/A

200

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.

Declared number of arm (3.0) differs from found arms (2.0)

Phase 2

[{"arm_notes": "", "treatment_id": 165, "treatment_name": "Azithromycin", "treatment_type": "Antibiotics", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]