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Purpose: To use a dose monitoring system for determining typical patient effective dose levels for optimization studies of x-ray exposures, with a focus on dental cone beam CT (CBCT) imaging. Material(s) and Method(s): A dose monitoring system (DOSE, Qaelum NV, Belgium) was used to collect radiation exposure data (i.e. the recorded Dose Area Product (DAP) value in dGy.cm2, Field Of View (FOV) selection in cm2, and the system operation mode), as well as the patient age for 5163 dental CBCT examinations performed in the university hospital of Leuven from January to December 2019, just prior to the Covid-19 pandemic. Examinations were performed on a 3D Accuitomo 170 (Morita, Japan) and a VGi EVO (NewTom, Italy) CBCT system. The extracted DAP values were corrected with an experimentally determined correction factor obtained during annual quality control tests. For each CBCT system, effective dose conversion factors (CFs) as a function of DAP and patient age were calculated and implemented in DOSE. CFs were determined for the following age groups: 4-6y, 7-11y, 12-14y, and >=15y. For the effective dose calculations, patient data was, for each system, further classified based on the selected FOV and operation mode. The FOV size was categorized into small (<=40 cm2), medium (>40 cm2 and <=100 cm2), or large (>100 cm2). Result(s): For the standard operation mode, average effective doses on the 3D Accuitomo 170 system as a function of age group were, from young to old: 77.7-300, 54.4-210, 39.9-154, 35.1-136 Sv, and for the VGi EVO system: 60.5-117, 12.1-97, 9.54-69.9, 9.26-61.5 Sv. For both systems, a decreasing trend in the effective dose with increasing age was observed. For each age group, the doses increased with increasing FOV size. The selected operation mode also influenced the dose to the patient (e.g. for the high-resolution mode on the VGi EVO system, 1.5-4 times higher effective doses were observed compared to the standard mode). The effective dose levels on the NewTom VGi evo system were significantly lower than on the 3D Accuitomo 170. For the VGi EVO system, the most frequently used system in clinical practice, the total radiation burden from the examinations was 0.22 manSv. Conclusion(s): This was one of the first studies providing a complete 1 year overview of dental CBCT effective doses in a university hospital dental department. The results could be used for optimization studies and/or to situate the exposures in comparison to multislice CT or panoramic examinations.Copyright © 2023 Southern Society for Clinical Investigation.
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Viruses have taken central place in public health due to the ongoing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. Antiviral treatments, and combination of antivirals, can be effective at reducing viral load shortly after infection, improving long-term outcomes. While it is obvious that choosing the right dose of treatment is a fundamental consideration, little has been published in terms of methodology for dose-finding trials in virology. The considerable progress in dose-finding methodology of the last few decades has focused almost entirely on oncology. However, the framework developed in oncology does not apply 1:1 to virology. While adverse reactions to cytotoxic drugs may be life threatening, for anti-viral agents, we anticipate something different: side effects that provoke the cessation of treatment. This would correspond to treatment failure. On the contrary, success would not be yes/no but would correspond to a range of responses, from small, no more than say 20% reduction in viral load to the complete elimination of the virus. Less than total success matters since this may allow the patient to achieve immunemediated clearance. In this presentation, we will introduce a novel methodology whose goal is twofold: first, to identify the dose that provides the most favorable distribution of treatment outcomes, and, second, to do this in a way that maximizes the treatment benefit for the patients included in the study. We will compare two modeling approaches in the talk. The first approach relies on the Bayesian Dirichlet-Categorical model to describe the toxicity/efficacy profile of each of the dose levels. The second approach relies on the principles of the continual reassessment model (CRM). We separately model the dose-toxicity curve and the dose-efficacy curve. By representing efficacy with three categories (low, medium, high viral load reduction), we can use the following assumptions: dose-efficacy curve is decreasing for the low-response category, and dose-efficacy curve in increasing for the high-response category. By combining the modeled toxicity and efficacy curves, we obtain the center of mass curve over the dose levels of interest. We will compare both approaches via simulations. The first approach described above has been recently published in Statistics in Medicine (doi: 10.1002/ sim.8771). The second approach is being currently developed and tested and will be the topic of a future publication.
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Background. We developed a COVID-Influenza Combination (CIC) vaccine, comprising recombinant SARS-CoV-2 Spike (rS) and quadrivalent influenza hemagglutinin (HA) protein nanoparticles (qNIV), and Matrix-MTM adjuvant. rS/Matrix-M previously demonstrated efficacy against COVID-19 in Phase 3 trials, while qNIV/ Matrix-M previously demonstrated induction of broadly cross-reactive antibodies. Here we report preliminary safety and immunogenicity results of a first-ever Phase 1/2 CIC dose-finding trial. Methods. Seropositive (COVID-19 vaccinated >= 8 weeks prior) participants (N=642) aged 50-70 years were randomized equally, to receive two intramuscular doses, 56 days apart, to 1 of 14 different dose/formulations of CIC using a design of experiments approach (dose range: rS 2.5-22.5ug, HA5-60ug;and 50ug Matrix-M), or to 1 of 2 reference formulations of either standalone rS with Matrix-M [2 doses] or qNIV with Matrix-M [1 dose only]. Pre- and post-vaccination (Days 0, 28, 56, 70, 84, 182) immunogenicity assessments including SARS-CoV-2 anti-S IgG and influenza HAI antibodies to vaccine-homologous strains. Reactogenicity was assessed 7 days following each dose, and safety outcomes assessed through Day 70. Multiple regression was used to create predictive models to assess antibody response surfaces and for dose optimization. Results. All CIC formulations were well tolerated, with a reactogenicity and safety profile generally comparable to standalone rS or qNIV. Regression modelling of post-first dose responses revealed that both rS and HA antigens in a CIC formulation modestly interfered with each other, however, interference was overcome with dose adjustment across a range of rS/HA doses. Specifically, higher rS dose ( >20ug), in a dose dependent fashion, overcame HA interference, closely matching standalone rS IgG reference responses (GMEU 16,818), whereas lower, intermediate HA dose overcame rS interference, closely matching standalone HA reference HAI responses for H3N2 (GMT 145), H1N1 (GMT 134), and B-Victoria (GMT 66);while modestly (at least 34%) lower than the reference B-Yamagata response (GMT 101). Conclusion. CIC formulations were well tolerated and immunogenic, with various dose combinations achieving response comparable to standalone vaccines.
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Introduction: The early use of sotrovimab has been approved in patients over 12 years of age and weighting more than 40kg, who are at risk of developing severe COVID-19. Although sotrovimab is the only monoclonal Antibody (mAb) effective against the "Omicron" variant of concern, data on its use in the paediatric population are still scarce. Herein, we present a case series of seven immunocompromised children younger than 12 years old, treated with sotrovimab at the University Hospital of Padua in 2022, proposing a readjusted formula for dosage calculation according to weight. Case: Two patients recently underwent solid organ transplantation, three had an onco-hematological disease, and two suffered a rare autoimmune disease. Five patients were older than 8 years old, while the remaining were 3 years and 10 months old, respectively. We adapted the Clark's rule by adjusting the original reference weight of 68kg to 40kg. The final formula was: (Patient's weight/40kg) x Adult Dose = Pediatric Dosage. While for four patients weighing approximately 40kg (+/- 4kg), sotrovimab was given at the standard dosage of 500mg, the others of 16, 13, and 8.5kg received 190mg, 150mg, and 100mg of mAb, respectively. Discussion(s): No patients experienced any adverse event and all resolved their SARS-Cov2-symptoms within three days, confirming the safety and effectiveness of the recalculated dosages. For the first time, we report a renewed intuitive model of mAb's dosage calculation, which allows the dose to be tailored to the patient according to weight. We chose to revise Clark's rule rather than other unvalidated methods because of its reliability and ease of use. Conclusion(s): Clinical pharmacist's skills are important in the review of off-label therapies, ensuring safe dosing even when evidence is lacking or limited. Although further pharmacokinetic analysis is needed, Clark's pharmacist-revised formula is a quick and safe way to modulate dosing for patients under 40kg.
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Background and Aims: Platelets are involved in inflammatory thrombosis in acute ischemic stroke (AIS) and severe Covid-19 infection. Glenzocimab, a humanized antibody fragment targeting platelet glycoprotein VI, has been assessed in two different indications. In AIS, with a single IV dose of 1000 mg to improve the efficacy of reperfusion therapies, in Covid-19, with 1000 mg over 3 consecutive days for acute respiratory distress syndrome (ARDS) treatment. Method(s): ACTIMIS (NCT03803007) was a safety and efficacy, dose-finding clinical study. Patients were randomly assigned to placebo or glenzocimab in an initial escalating dosage scheme from 125 to 1000 mg, then to 1000 mg or placebo in 1:1 parallel groups. The primary endpoint was safety focusing on intracranial hemorrhages (ICHs). GARDEN (NCT04659109) was an exploratory efficacy and safety clinical trial. Patients randomized 1:1 to glenzocimab or placebo. Safety was a key secondary endpoint. Result(s): Within ACTIMIS, 166 patients were enrolled, 66 (40%) reported as ICH;6 were symptomatic ICH: on glenzocimab 1/102 patients (1%), on placebo 5/64 (8%);60 displayed non-symptomatic ICHs, on glenzocimab 30/102 (29%), on placebo 30/64 (47%). Twenty all-cause deaths were reported, 8/102 (8%) on glenzocimab and 12/64 (19%) on placebo. In GARDEN, safety analysis in 61 patients confirmed the favorable profile of glenzocimab with no mortality, no serious drug-related adverse event, no major bleeding. All results are consistent with those from phase I in healthy volunteers (Arterioscler Thromb Vasc Biol. 2019;39). Conclusion(s): This favorable safety profile within three clinical studies allowed glenzocimab, a novel antithrombotic, to enter a larger ongoing phase II/III study,.
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Introduction: There are no effective treatments for non-active secondary progressive MS (SPMS), which is mediated by compartmentalized CNS inflammation, including activated microglia. We found that fully human anti-CD3 intranasal monoclonal antibody (Foralumab) suppressed disease in a chronic EAE model by dampening microglia and astrocyte inflammation. Nasal Foralumab does not enter the bloodstream or brain. A dose-finding study of nasal Foralumab in controls dosed at 10ug, 50ug and 250ug for 5 days found the drug to be safe with immune effects seen at 50ug. COVID patients dosed with 100ug of nasal Foralumab for 10 days was well-tolerated and exhibited positive effects on blood markers and lung inflammation. Objective(s): To determine if nasal Foralumab has a therapeutic effect on patients with non-active SPMS. Method(s): Two patients were identified with non-active SPMS and sustained clinical progression, despite use of approved DMT. EA1 is a 61-year-old male diagnosed for over 20 years and EA2 is a 42-year-old male diagnosed for 8 years, both last treated with ocrelizumab for 3 years. Treatment occurs in 3-week cycles with intranasal Foralumab 50ug/day administered 3x/week for 2 weeks with 1 week rest. Each cycle, clinical and neurological assessments are repeated, and imaging is repeated every 3 months. Result(s): EA1 has completed 6 months and EA2 has completed 3 months of treatment. To date, there have been no adverse reactions, local irritation, or laboratory abnormalities, and symptom progression has subsided. EA1 is feeling more stable, subjectively, and has noted improvement in lower extremity strength. EDSS, pyramidal motor score and T25FW have stabilized or improved. SDMT and 9HPT were stable during treatment. Microglial activation as measured by [F-18]PBR06 PET scan was significantly reduced 3 months after the start of nasal Foralumab, and this reduction was sustained after 7-week washout and at 6 months. Serum protein measurements of cytokines showed reduction of IFN-gamma, IL-18, IL-1s and IL-6 levels (Olink assay). Cellular immune studies showed increase in CD8 naive cells and decrease in CD8 effector cells, and alteration in gene expression as measured by single cell RNA sequencing. EA2 3-month laboratory and imaging results are pending and will be presented. Conclusion(s): Nasal Foralumab in non-active SPMS patients treated for at least 3 months reduced microglial activation, decreased levels of proinflammatory cytokines, and had positive clinical effects.
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BACKGROUND: A novel therapeutic approach using molecularly targeted radiation is currently in development for patients with recurrent GBM. Many tumor types, including GBM, overexpress the L-type amino transporter 1 (LAT-1)4, which is able to internalize the small-molecule amino acid derivative, 4-L-[131I] iodo-phenylalanine (131I-IPA). In preclinical research, combining 131I-IPA with external radiation therapy (XRT) yielded addi- tive cytotoxic effects. Tumoral accumulation of 131I-IPA was confirmed in a proof-of-principle study using single doses of 2-7 GBq 131I-IPA as a monotherapy or in combination with XRT in patients with recurrent GBM. The objective of the IPAX-1 study was to evaluate the safety, tolerability, dosing schedule, and preliminary efficacy of 131I-IPA in combination with secondline radiotherapy in patients with recurrent GBM. METHOD(S): IPAX-1 is a multi-center, open-label, single-arm, dose-finding phase 1/2 study. Key inclusion criteria: 1. Confirmed histological diagnosis of GBM with evidence of first recurrence 2. History of GBM standard therapy 3. >= 6 months since end of first-line XRT 4. Pathologically increased amino acid tumor uptake shown by molecular imaging 5. Current indication for repeat radiation 6. Gross tumour volume of up to 4.8 cm diameter. Treatment: In phase 1 of the study patients received intravenous 131I-IPA at a dose level of 2 GBq administered in one of three different dosing regimens: single dose group with 2 GBq before radiation, 3 (f)-fractionated-parallel group: 3 x 0.67 GBq during XRT and 3 (f)-fractionated-sequential group: 0.67 GBq x 1 -> XRT -> 0.67 GBq x 2. XRT is delivered in 18 fractions of 2 Gy each. RESULT(S): 10 patients were randomized;one patient with Covid related death was withdrawn from analysis. Survival from start of TLX101 therapy showed mPFS2 of 4.33 M (95% -CI 4.18 - 4.48), PFS-6: 18 % and mOS2 of 15.97 M (95% -CI 2.9 - 29.1) at data lock 09/2021. Updated results will be presented at the meeting. CONCLUSION(S): There were no clinically relevant laboratory changes over time. Urinalysis, vital signs, and ECG did not show any clinically relevant changes from baseline. There were no notable differences in safety and tolerability between groups. Injections of single or fractionated doses of 131I-IPA containing a total activity of 2 GBq in combination with XRT in patients with recurrent GBM were safe and well tolerated. Survival data look promising;extension cohort will be treated in a phase II study in Linz;phase 1/2 study in first line setting is planned.
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Background The widespread use of medical software applications and internet for browsing health related topics have become a novel way to improve health and health care delivery system. Especially, in these days when covid 19 pandemic have struck the world so badly that people have less access to hospitals for their routine medical care, mHealth have shortened the distance between a patient and doctor. Advancements in mobile technologies and better reach of mobile networks have accelerated the usage of mobile apps and other electronic devices for planning,programming and executing various health care services round the globe. Even in India during the covid pandemic, use of mobile apps like Arogya Setu have made a great impact in planning and provision of health care. This study aims at assessment of awareness on mHealth among undergraduate medical students in a tertiary centre at Maharashtra, India. Methodology A cross sectional study was conducted among undergraduate medical students of Government Medical College, Aurangabad, Maharashtra. A pretested semi structured questionnaire was used to collect data from the medical students. About 400 students studying in first year and second year were included in the study. An informed consent was attached along with the questionnaire. Collected data was entered in MS Excel and analyzed using SPSS 26 trial version. Quantitative data was expressed in terms of mean and standard deviation, categorical data was expressed as frequencies and percentages. Chi-square test was used to check the association between the parameters. Data was represented in tabular and graphical form. Result Among the 379 participants,226(59.63%) were males and 153(40.36 %) were females.55.4% belonged to age group above 20 years,85.22% were Hindus. 82.32% belonged to Class I socioeconomic class according to modified B G Prasad's classification. Among the respondents,47.75% only had adequate knowledge, 54.8% had appropriate attitude and 64.3% followed appropriate practice regarding mHealth. About 70% thought that usage of health related apps is not a wastage of time.87.07 % browse internet for health related queries and 76.78% of them spend only less than 30 minutes for that. 67.8% do not prefer to recommend health related apps to their colleagues. About 57% are expecting more health related apps in future, after solving the glitches in the currently available ones. Among the respondents, 95 (55.8%)of those belonging to age group less than 20 years have adequate knowledge regarding m-health, while only 40.6% of those belonging to age group more than 20 years had adequate knowledge in this regard (p value= 0.0015). Males had more knowledge about mHealth than females (p=0.0015).102 respondents belonging to 1st year MBBS(54.5%) had adequate knowledge as compared to 79 belonging to 2nd year MBBS(41.4%) (p=0.004). Males had a better attitude regarding mHealth than females(p= 0.016).Also, respondents aged less than 20 years had better appropriate practice of mHealth than others (p=<0.00). Conclusion In this study,it has been found that more awareness must be created among health care professionals regarding use of mHealth in healthcare delivery. Majority of the respondents agreed upon the utility of health related apps in easy access to national guidelines and lab reference, faster medical score and dose calculations and for acquiring knowledge, developing skills and for evidence based practice. Hence in this context, developing an e-platform for the same can save time,money and manpower to a great extend. Therefore, focus must be on creating apps which are user friendly and which provides maximum data in short span of time. Periodic quality checks on apps must be given to ensure accurate content delivery. Copyright © 2022 Ubiquity Press. All rights reserved.
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Background: Patients (pts) with follicular lymphoma (FL) generally respond well to first-line CD20-targeted therapies, such as obinutuzumab or rituximab-based regimens. However, many pts relapse and studies suggest that each subsequent relapse is associated with shorter durations of response to the next treatment. Parsaclisib is a potent and highly selective next generation PI3Kδ inhibitor. The combination of bendamustine + obinutuzumab is approved for pts with relapsed/refractory (R/R) FL. We hypothesized that adding parsaclisib may improve clinical benefit with a manageable safety profile in this pt population. Aims: CITADEL-102 (NCT03039114) is an open-label, phase 1, dose-finding study that investigated safety and efficacy of parsaclisib in combination with bendamustine + obinutuzumab in pts with R/R FL following rituximabcontaining regimens. Methods: Pts enrolled were ≥18 years with histologically confirmed CD20-positive FL, R/R to any prior rituximabcontaining regimen, ECOG PS 0-2, ≥1 measurable lesion, and ≤4 prior therapies. Pts received parsaclisib 20 mg orally once daily (QD) for 8 weeks then 20 mg once weekly (QW);bendamustine 90 mg/m2 infusion on days 1 and 2 of cycles 1-6;and obinutuzumab 1000 mg infusion on days 1, 8, and 15 of cycle 1, and day 1 of cycles 2-6, and on every second cycle of cycles 8-30 in pts having complete response/complete metabolic response (CR/CMR), partial response/partial metabolic response (PR/PMR), or stable disease/no metabolic response. Part 1 (safety run-in) used a 3+3 design with dose de-escalation to identify the maximum tolerated dose (MTD) of parsaclisib in combination with bendamustine + obinutuzumab. In Part 2 (dose expansion), the safety and efficacy of this combination were further evaluated. The primary study endpoint was safety and tolerability;secondary endpoints included efficacy outcomes (ORR, DOR, PFS, and OS). Results: A total of 26 pts were enrolled and treated;median (range) age was 65.0 (44-80) years, 25 (96.2%) had ECOG PS ≤1, 11 (42.3%) had ≥2 prior systemic therapies, and 6 (23.1%) had received prior bendamustine. Median (range) parsaclisib exposure was 10.6 (0.4-32.8) months. Main reasons for treatment discontinuation included adverse events (AEs) (8 pts, 30.8%) and progressive disease (6 pts, 23.1%). All pts experienced treatment-emergent AEs (TEAEs);most common any-grade TEAEs (≥10 pts) were pyrexia (53.8%), neutropenia (50%), diarrhea (46.2%), thrombocytopenia, and nausea (each 38.5%). Grade ≥3 TEAEs were experienced by 88.5% of pts;most common grade ≥3 TEAEs (≥2 pts) were neutropenia (34.6%), febrile neutropenia (23.1%), thrombocytopenia (19.2%), ALT and AST increase (each 11.5%), and diarrhea, neutrophil count decreased, and rash maculopapular (each 7.7%). One of 6 evaluable pts in Part 1 had a DLT of grade 4 QTc elongation. The MTD was not reached, and parsaclisib 20 mg QD for 8 weeks then 20 mg QW was the selected dosage for dose expansion in Part 2. Treatment discontinuation due to TEAEs was 30.8%, 7.7%, and 15.4% for parsaclisib, bendamustine, and obinutuzumab, respectively. One fatal TEAE (COVID-19 pneumonia) occurred. ORR (95% CI) as reported by the investigator was 76.9% (56.4-91.0), with 17 pts (65.4%) achieving CR/CMR and 3 pts (11.5%) achieving PR/PMR as the best overall response. Median DOR, PFS, and OS were not reached. Summary/Conclusion: Parsaclisib in combination with bendamustine + obinutuzumab appears to have a manageable safety profile and demonstrated promising efficacy in pts with R/R FL.
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The antiviral effect of garlic and its organosulfur and lectin compounds is beyond any doubt. In vitro experiments demonstrate the virucidal effect on viruses without envelopes or with envelopes. The latter are the ones causing pandemics. The antiviral mechanism of action include various targets, e. g. receptor interaction, inhibition of enzymes that enable penetration into cells, inhibition of replication and excretion of virions. Seven exploratory studies indicate a potent antiviral effectiveness in humans. Confirmatory studies must now evaluate the effect size for every garlic preparation after dose-finding studies have established the optimum daily dosage for the prevention and treatment of viral infections.
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Background: Adoptive cell immunotherapies for opportunistic virus in immunocompromised patients using haploidentical memory T cells have shown to be safe and effective. Since severe cases of COVID-19 present a dysregulated immune system with T cell lymphopenia and a hyper-inflammatory state we have proposed that a similar strategy could be proven to be efficient for COVID-19 patients. This is a study protocol of an open-label, multicenter, double-arm, randomized, dose-finding phase I/II clinical trial to evaluate the feasibility, safety, tolerability, and efficacy of the administration of a single dose of allogenic SARS-CoV-2 specific memory CD45RA - T cells and Natural Killer (NK) cells in COVID-19 patients with lymphopenia and pneumonia. The aim of the study is to find efficient treatments for patients with moderate/severe COVID-19. Identification of Specific memory T cells and NK cells: i)Memory T Cells: we first determined the existence of SARS-CoV-2 specific T cells within the CD45RA - T memory cells of the blood of convalescent donors. Memory T cells can respond quickly to the infection and provide long-term immune protection to reduce the severity of the COVID-19 symptoms without inducing classically T cell alloreactivity. Also, CD45RA - memory T cells confer protection for other pathogens the donors encountered in their life. ii)NK cells: we determined the phenotype of NK cells after COVID-19 and the main characteristic of SARS-CoV-2 specific NK population in the blood of convalescent donors, as it has been shown for cytomegalovirus infections. Also, NK cells confer protection for other pathogens the donors encountered in their life. Pilot Phase I- Safety, feasibility, and dose escalation: Between September and November 2020 a phase 1, dose-escalation, single-center clinical trial was conducted to evaluate the safety and feasibility of the infusion of CD45RA - memory T cells containing SARS-CoV-2 specific T cells as adoptive cell therapy against moderate/severe cases of COVID-19. Nine participants with pneumonia and/or lymphopenia and with at least one human leukocyte antigen (HLA) match with the donor were infused. The first three subjects received the lowest dose (1x10 5 cells/kg), the next three received the intermediate dose (5x10 5 cells/kg) and the last three received the highest dose (1x10 6 cells/kg) of CD45RA - memory T cells. Clinicaltrials.gov registration: NCT04578210. Findings: All participants' clinical status measured by National Early Warning Score (NEWS) and 7-category point ordinal scales showed improvement six days after infusion. No serious adverse events were reported. Inflammatory parameters were stabilized post-infusion and the participants showed lymphocyte recovery two weeks after the procedure. Donor microchimerism was observed at least for three weeks after infusion in all patients. Interpretation: This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using convalescent SARS-CoV-2 specific CD45RA - memory T cells is feasible and safe. We did not find dose-liming toxicity. The Recommended Phase 2 dose was 1x10 6 CD45RA - T cells. Phase II- Efficacy: Between January 2021 and July 2021 patients have been enrolled based on the matched with the HLA genotype of the convalescent donors and following the protocol inclusion/exclusion criteria. The primary outcome is the incidence of patient recovery at day 14, defined as normalization of fever and oxygen saturation or lymphopenia recovery. Secondary outcomes are the time to normal level of lymphocytes, the proportion of patients showing clinical improvement at day 7, time to first negative SARS-CoV-2 PCR, the incidence of treatment-related adverse events, duration of hospitalization, time to discharge, time to improvement by one category a 7-point ordinal scale or NEWS score, the proportion of patients requiring intensive care unit, and all-cause mortality. In addition, lymphocyte recovery by multiparametric flow cytometry and donor chimerism by real-time PCR in the e perimental arm was monitored weekly during the first month. This study provides preliminary evidence supporting the idea that treatment of COVID-19 patients with moderate/severe symptoms using convalescent CD45RA - memory T cells is safe and feasible. The phase II clinical trial is ongoing to demonstrate efficacy. [Formula presented] Disclosures: Soria: Celgene: Other: Fees;Gilead: Other: Fees;AbbVie: Other: Fees.