COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04896606

Mitchell S Cairo, MD

mitchell_cairo@nymc.edu

2021-05-21

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Treatment

inclusion criteria - age ≥18 to 65 years. and - proven infection with sars-cov-2, defined as detection of sars-cov-2 by rt-pcr from nasopharyngeal swab or lower respiratory tract specimen and - hospitalized at the time of enrollment and - hla matched family related donor with recent sars-cov-2 infection is at least 10 days out from symptom onset. a negative result for covid-19 by a diagnostic test is not necessary to qualify the donor and - in stage i or ii of disease (mild or moderate) at the time of enrollment (table 1) and - one of the following high-risk conditions: - chronic lung disease not requiring oxygen at home prior to admission (including but not limited to copd, cystic fibrosis, asthma and sickle cell disease); underlying heart disease (including hypertension); patients with an acute myocardial infarction within the last 3 months will require cardiology clearance prior to enrollment; diabetes mellitus (type i or ii) ; obesity (bmi ≥ 30); immunosuppressed, based on investigator's assessment.

- stage iii disease (severe) at the time of enrollment (see table 1) - lack of an identified eligible hla family related donor - no high-risk comorbidities defined in the inclusion criteria (section 5.1) - patient with acute gvhd > grade 2 or extensive chronic gvhd at the time of enrollment - patient treated with donor lymphocyte infusion (dli) within 4 weeks prior to ctl infusion - patients with chronic respiratory failure requiring ventilator support and/or oxygen at home prior to admission are excluded - patients with stage d heart failure and/or symptoms at rest are excluded - renal function: patients with egfr or crcl <30 ml/min/1.73 m2 will be excluded from study entry. - liver function: total bilirubin > 2 mg/dl (unless gilbert's syndrome) or alt/ast > 5 x uln - patients currently listed for transplant or potentially eligible to receive organ transplants are excluded from this study - patient with poor performance status determined by karnofsky (patients >16 years) or lansky (patients ≤16 years) score ≤50% - female patient of childbearing age who is pregnant or breast-feeding or not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. - male subjects with female partners of childbearing age who are not willing to use an effective method of birth control during study treatment and for at least 6 weeks after the last dose of sars-cov-2 ctls. - concurrent use of following medications is prohibited: - steroids (>2 mg/kg/day prednisone equivalent); immunotherapies within 4 weeks prior to ctl infusion including checkpoint blockade, atg, campath, car t cells, blinatumomab; chemotherapy: tyrosine kinase inhibitors and hydroxyurea must be stopped > 72 hours prior to sars-cov-2-ctl cell infusion; high dose chemotherapy must be stopped > 2 weeks prior to sars-cov-2-ctls. high dose chemotherapy is defined in this protocol as any cancer directed therapy causing myelosuppression; pegylated-asparaginase must be stopped > 4 weeks prior to sars-cov-2-ctl infusion; intrathecal chemotherapy must be stopped > 1 week prior to sars-cov-2-ctl infusion (e.g. intrathecal methotrexate); anti t-cell antibodies: administration of any t cell lytic or toxic antibody (e.g. alemtuzumab) within 30 days prior to sars-cov-2-ctls is prohibited.

2

New York Medical College

18

65

United States

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

50

Incidence of adverse events

None

Phase 1/Phase 2

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