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Background The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. Currently, with insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed. Method An adaptive, multicentric, open-label, and randomized controlled phase I/II clinical trial entitled the “SENTAD-COVID Study” was conducted by the Abu Dhabi Stem Cells Center under exceptional conditional approval by the Emirates Institutional Review Board (IRB) for COVID-19 Research Committee from April 4th to July 31st, 2020, using an autologous peripheral blood non-hematopoietic enriched stem cell cocktail (PB-NHESC-C) administered by compressor (jet) nebulization as a complement to standard care therapy. The primary endpoints include safety and efficacy assessments, adverse events, the mortality rate within 28 days, and the time to clinical improvement as measured by a 2-point reduction on a seven-category ordinal scale or discharge from the hospital whichever occurred first. Results The study included a total of 139 randomized COVID-19 patients, with 69 in the experimental group and 70 in the control group (standard care). Overall survival was 94.20% for the cocktail-treated group vs. 90.27% for the control group. Adverse events were reported in 50 (72.46%) patients receiving PB-NHESC-C and 51 (72.85%) in the control group (p = 0.9590), with signs and symptoms commonly found in COVID-19. After the first 9 days of the intervention, 67.3% of cocktail-treated patients recovered and were released from hospitals compared to 53.1% (RR = 0.84; 95% CI, 0.56–1.28) in the control group. Improvement, i.e., at least a 2-point reduction in the severity scale, was more frequently observed in cocktail-treated patients (42.0%) than in controls (17.0%) (RR = 0.69; 95% CI, 0.56–0.88). Conclusions Cocktail treatment improved clinical outcomes without increasing adverse events. Thus, the nebulization of PB-NHESC-C was safe and effective for treatment in most of these patients. Trial registration ClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.

Background SARS-CoV-2 is a highly contagious virus that spread worldwide with a rapid increase in the number of deaths. In March 2020, the WHO declared SARS-CoV-2 a pandemic. The primary diagnostic test is reverse transcription-polymerase chain reaction, but chest X-ray and computed tomography have become the typical diagnostic tools used to detect abnormal lung changes. Within the framework of the SENTAD COVID Study clinical trial, an observational and analytical study was conducted, where the patients received nebulization therapy with the use of autologous stem cells (group A) compared to the control arm (group B). Both groups received the UAE SARS-CoV-2 standard management. Radiological images of each patient were collected within 24 h of inclusion in the trial and during follow-up. Herein, we describe and evaluate the radiological findings and outcomes. Results A total of 139 subjects were included in our analysis, 69 in group A and 70 in group B. The most common finding was ground glass opacifications, followed by patchy consolidations, with 20% normal radiological images scored 3 from admission until discharge (p < 0.0001). Our results suggest a significant improvement in radiological images after treatment secondary to the stem cell effect of reducing inflammation and stimulating the pneumological healing process. Conclusions The use of novel therapies, such as stem cells, shows efficacy not only in terms of the control of clinical and paraclinical signs but also in the radiological changes described in the disease. Trial registration Study evaluating the safety and efficacy of autologous non-hematopoietic peripheral blood stem cells in COVID-19. Trial registration number: NCT04473170. Date of registration: 16 July 20202. Retrospectively registered.