A randomized controlled trial of adjuvant inhalable sodium bicarbonate role in treatment of COVID-19
Mohammad El-Badrawy, Rehab Elmorsey, Mohammed Shehta, Tamer El-Hadidy, Ibrahim Abdelwahab, Adel El-Badrawy, Ahmed Shokeir
doi:10.21203/rs.3.rs-2214180/v1
Entry of coronavirus (SARS-CoV-2) into a host cell is pH dependent. Intracellular alkalinization by sodium bicarbonate (SB) could elevate endosomal pH and block viral entry into the host cells. So, we assessed the role of inhalable SB as an adjuvant treatment for COVID-19 in the study groups of this randomized, controlled trial. Here we show a signi cantly shorter duration to clinical improvement and hospital stay in the study group, while the number of deaths is signi cantly less only in severe grade of the study group. But the time to death is not signi cantly different in both groups. CRP and d-dimer levels are signi cantly lower in the severe cases of the study group. The overall median CT score is signi cantly better in the study group at one & 2 months. Our data thus suggest that inhaled SB (8.4%) could be a possible adjuvant therapy for patients with moderate and severe COVID-19 pneumonia. concluded that SB 8.4% inhalation with its nasal instillation could be a possible adjuvant therapy for patients with non-severe COVID-19 pneumonia [11] . Nevertheless, that study had several shortcomings, being nonrandomized, with limited number of patients and short duration of follow-up. Moreover, that study excluded mild and severe cases of COVID-19 and included moderate cases only identi ed according to CT ndings The current study was designed to avoid the disadvantages of the previous nonrandomized small study and to provide consolidated information regarding the role of inhalable SB as an adjuvant treatment of COVID-19.
Results Between -September 1st, 2021, and April 30, 2022, we recruited 956 patients presented with symptoms suggestive of COVID-19, a total of 546 ful lled the inclusion criteria, completed the study, followed and analyzed as shown in the CONSORT ow chart (Fig. 1 ). The patients were randomly assigned into study group (n = 272) and control group (n = 274). Both groups were comparable in term of demographics, vaccination, co-morbidities, clinical presentation, COVID disease grades, severity of clinical presentation, laboratory parameters, and CT score. The place of treatment was also comparable among patients of both groups (Table1). All cases of both groups completed one week of follow-up. A total of 238 patients of the study and 229 of the control groups completed one month of followup. At 2 months, 234 of the study and 220 of the control groups were available for analysis. Figure 1 shows the causes of dropouts.
Primary Outcomes Primary outcomes are shown in table (2). The overall duration to clinical improvement was signi cantly shorter in the study group. This observation is maintained in all grades of the disease. For patients requiring hospital admission, the overall duration of hospital stay was signi cantly shorter in the study group. This signi cant difference was evident in moderate and severe grades but not in critical cases. The overall frequency of death was not signi cantly different between both groups. No..
Author contributions Mohammad Khairy El-Badrawy, Mohammed Shehta, Tamer Ali El-Hadidy, and Rehab Ahmad Elmorsey Contributed to the treatment of the cases. Mohammad Khairy El-Badrawy, Ahmed A. Shokeir, Tamer Ali El-Hadidy, and Rehab Ahmad Elmorsey prepared the scienti c rational of the study. Adel El-Badrawy, performed and interpreted the CT. Ahmed A. Shokeir, Mohammad Khairy El-Badrawy, Rehab Ahmad Elmorsey, Mohammed Shehta, and Ibrahim El-Said Abdelwahab wrote the rst draft of the manuscript. Ahmed A. Shokeir, and Rehab Ahmad Elmorsey performed the statistical analysis of the study. All authors read and approved the manuscript.
Competing interests The authors declare that they have no con icts of interest with the contents of this article.
Supplementary Files This is a list of supplementary les associated with this preprint. Click to download.
rawdatalfornature.xlsx
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