ABSTRACT
Objective: Mesenchymal stem cells can serve as a therapeutic option for COVID-19. Their immunomodula-tory and anti-inflammatory properties can regulate the exaggerated inflammatory response and promote recovery of lung damage. Method: Phase-1, single-centre open-label, prospective clinical trial was conducted to evaluate the safety and efficacy of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in moderate COVID-19. The study was done in 2 stages with total 20 patients. Herein, the results of stage 1 including first 10 patients receiving 100 million cells on day 1 and 4 with a follow up of 6 months have been discussed. Results: No adverse events were recorded immediately after the administration of MSCs or on follow up. There was no deterioration observed in clinical, laboratory and radiological parameters. All symptoms of the study group resolved within 10 days. Levels of inflammatory biomarkers such as NLR, CRP, IL6, ferritin and D-dimer improved in all patients after intervention along with improved oxygenation demonstrated by improvement in the SpO2/FiO2 ratio and PaO2/FiO2 ratio. None of the patients progressed to severe stage. 9 out of 10 patients were discharged within 9 days of their admission. Improvements were noted in chest x-ray and chest CT scan scores at day 7 in most patients. No post-covid fibrosis was observed on chest CT 28 days after intervention and Chest X ray after 6 months of the intervention. Conclusion: Administration of 100 million mesenchymal stem cells in combina-tion with standard treatment was found to be safe and resulted in prevention of the cytokine storm, halting of the disease progression and acceleration of recovery in moderate COVID-19. This clinical trial has been registered with the Clinical Trial Registry-India (CTRI) as CTRI/2020/08/027043. http://www.ctri.nic.in/Clinicaltrials/pmaindet2. php?trialid=43175.
ABSTRACT
OBJECTIVE: In the current pandemic, Health Care Workers (HCWs) are at a high risk of developing COVID-19. Preventive methods like the use of personal protective equipment, isolation, social distancing, and chemoprophylaxis show limited benefit. Despite standard prophylaxis, many of the HCWs develop COVID-19. Medical ozone therapy has immunomodulatory, antioxidant and antiviral effect, and, therefore, it can be explored as prophylaxis for COVID-19. PATIENTS AND METHODS: We conducted a retrospective controlled cohort study. IV ozonized saline was administered once a day for a total of 4 days in one month in addition to standard prophylaxis for COVID-19 to HCWs in a dedicated COVID hospital. Fresh ozonized saline was prepared for every administration and was given over 1 hour. RESULTS: There were 235 HCWs, 64 received the ozone prophylaxis and 171 did not. The incidence of COVID-19 was significantly (p=0.04) lesser in HCWs that received ozone prophylaxis (4.6%) as compared to those who did not (14.03%). The benefit was seen irrespective of the risk of exposure. In the red zone, 8.69% of the HCWs who received ozone prophylaxis tested positive as opposed to 15.3% of those who did not. In the orange zone, 4.34% of the HCWs who received ozone prophylaxis tested positive, remarkably lesser than those who did not (20%). In the green zone, none of the HCWs who received ozone prophylaxis tested positive; however, 3.4% of the HCWs who did not receive ozone prophylaxis tested positive. No major adverse events were noted. CONCLUSIONS: IV ozonized saline can be used in addition to the standard prophylactic regimen for the prevention of COVID-19 in HCWs. Prospective larger studies are required to establish the potency of IV ozonized saline as prophylaxis.