ABSTRACT
Bacillus Calmette-Guerin (BCG) is a vaccine for tuberculosis and is administered at birth in several countries, however there are many countries that have no BCG vaccination policy and coincidently they are worst hit by Covid-19 pandemic in terms of disease severity and mortality.The study was conducted to determine the association between BCG vaccine and COVID-19 severity. Study included total 150 participants visiting Department of Medicine, Mayo Hospital, Lahore, Pakistan. Data regarding BCG vaccination, comorbidity, demographics, disease severity were collected through self-structured questionnaire using non-probability convenient sampling. Prior written informed consents were taken from the participants. Male and female were in equal proportion. 68.6% were married, only 3.9% were smokers. Analysis revealed that only 10 (6.5%) were hypertensive and10 (6.5%) were diabetic. There was no BCG vaccine protection against Covid-19 in the current study. Severity of disease was similar in vaccinated and non-vaccinated patients. But it can not be applicable to whole population. Another fact is that most of Pakistani population is BCG vaccinated due to national policy and coincidently Pakistan suffered less as compared to high hit countries. There maybe some association between BCG vaccination and Covid-19 or some other environmental factor and genetics that need to be explored.
ABSTRACT
Introduction: Effective treatment for patients with the novel Coronavirus Disease (COVID-19) is desperately needed and is under rigorous research. Nigella sativa oil (NSO), a herbal medicine, that has a documented wide antiviral and immunomodulatory activities offering a therapeutic potential for COVID-19. Methods: Adult symptomatic patients with mild COVID-19 were recruited between May and August 2020 from King Abdulaziz University Hospital in Jeddah, Saudi Arabia. They were randomly assigned to receive supplementation with oral capsules of NSO (MARNYS' Cuminmar 500 mg twice daily for 10 days) plus standard of care or standard of care medications alone. The primary endpoint was the proportion of patients recovered (free of symptoms for 3 days) within 14 days after randomization. This trial was registered with clinicaltrials.gov, NCT04401202. Results: A total of 120 patients were enrolled. Their mean age was 35 (SD=11) years old and 57% of them were male. There were 60 patients in the treatment group (NSO) and 60 patients in the control group. The proportion of patients recovered in the treatment group was significantly higher than the control group, 42 (70%) versus 27 (45%) (p=0.006). Additionally, there was a significant difference in the average recovery time among both groups, 9.9 (SD=3.3) versus 11.6 (SD=3.4) days (p=0.006). Furthermore, 3 patients from the control group required hospitalization within the study period versus one in the treatment group. Adverse events were reported in 3 patients of NSO recipients as gastrointestinal symptoms. Conclusion: In this RCT of adult patients with mild COVID-19, NSO was associated with a significant increase in the likelihood of recovery and a decrease in the likelihood of hospitalization. To our knowledge, this is the first RCT that shows potential therapeutic benefits of NSO in patients with COVID-19 which requires further confirmation with larger double-blinded RCTs. Keywords: Black seed, Nigella sativa, COVID-19, SARS-CoV-2;randomized controlled trial