COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04578210

Antonio Pérez Martínez

Víctor Alelú Hernández, victor.alelu.ucicec@gmail.com (PI email not reported)

2020-10-08

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

inclusion criteria: - male or female patients ≤ 80 years of age. - patient with diagnosis of covid-19 infection with laboratory confirmation by reverse-transcription pcr (rt-pcr) of sars-cov-2 <72 hours prior to study entry. - onset of symptoms < 10 days prior to administration of study treatment. - no more than 72 hours (3 days) of hospitalization before study treatment administration. - phase i criteria: patients requiring hospitalization for covid-19, with pneumonia diagnosed with chest radiograph or computed tomography imaging or lymphopenia (absolute lymphocyte counts below 1.2 x 109cells /l) and o2sat ≤ 94% on room air at screening, no oxygen requirement or with an oxygen need of ≤ 2.5 lpm in nasal cannula. - phase ii criteria: patients requiring hospitalization with pneumonia diagnosed with chest radiograph or computed tomography imaging or lymphopenia (absolute lymphocyte counts below 1.2 x 109cells /l) and o2sat ≤ 94% on room air at screening, requiring or not oxygen supplementation (nasal cannula, oxygen mask with reservoir, non-invasive ventilation, etc), but excluding mechanical ventilation. - have a negative pregnancy test documented prior to enrollment (for females of childbearing potential). - be willing and able to comply with study procedures. - patients with the ability to comprehend and sign the informed consent - written informed consent obtained prior to any screening procedures.

- enrolled in another clinical trial for covid19. - rapidly progressive disease with anticipated life-expectancy <72 hours. - patients requiring mechanical ventilation. - patients with multiorgan failure. - mild-moderate (grade ≥ 3) organ impairment (liver, kidney, respiratory), according to criteria from the national cancer institute (nci ctcae version 5.0). - severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol. - have a known history of human immunodeficiency virus infection, hepatitis b or hepatitis c; testing is not required in the absence of prior documentation or known history. - pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hcg laboratory test. - any other condition that, in the opinion if the investigator, may interfere with the efficacy and/or safety evaluation of the trial.

2

Instituto de Investigación Hospital Universitario La Paz

2

80

Spain

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

84

Phase II;Phase I: Occurrence of DLTs in all patients during the study treatment, until 21 days after cell infusion and the MTD

None

Phase 1/Phase 2

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