Abstract
BackgroundThe 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.MethodAn 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.ResultsThe 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).ConclusionsCocktail 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 registrationClinicalTrials.gov. NCT04473170. It was retrospectively registered on July 16th, 2020.
Highlights
In December 2019, a novel member of the family of severe acute respiratory syndrome coronaviruses named SARS-CoV-2 rapidly spread from China throughout the globe, causing a pandemic of the human respiratory illness recognized as coronavirus disease 2019 (COVID-19) [1]
COVID19 severe cases are characterized by severe pneumonia, acute respiratory distress syndrome (ARDS), excessive acute inflammatory responses, development of cytokine storms, and multiple organ failures leading to death
Group A included 69 patients (65 males, four females) aged 45.93 ± 9.75 years old to assess the investigational product plus the standard COVID-19 care treatment established by the Ministry of Health and Prevention of the United Arab Emirates (MOHAP) [24]
Summary
In December 2019, a novel member of the family of severe acute respiratory syndrome coronaviruses named SARS-CoV-2 rapidly spread from China throughout the globe, causing a pandemic of the human respiratory illness recognized as coronavirus disease 2019 (COVID-19) [1]. The United Arab Emirates (UAE) has shown a sharp and chaotic increase in the number of confirmed COVID-19 patients [2] despite the country’s nationwide efforts to control the disease by introducing a series of strict measures to stop the spread of infection. After a noticeable surge of cases, the UAE declared a state of emergency to fight coronavirus, emphasizing the need for a new approach for treatment to decrease disease progression and related deaths. SARS-CoV-2 infection can cause a broad spectrum of symptoms, ranging from mild to severe illness. The novel SARS-CoV-2 has caused the coronavirus disease 2019 (COVID-19) pandemic. With insufficient worldwide vaccination rates, identifying treatment solutions to reduce the impact of the virus is urgently needed
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