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Nandeeta Samad,1 Siddhartha Dutta,2 Temitayo Eniola Sodunke,3 Adiba Fairuz,4 Ashmita Sapkota,5 Zannatul Ferdous Miftah,6 Iffat Jahan,7 Paras Sharma,8 Abdullahi Rabiu Abubakar,9 Adekunle Babajide Rowaiye,10 Angus Nnamdi Oli,10 Jaykaran Charan,2 Salequl Islam,11 Mainul Haque12 1Department of Public Health, North South University, Dhaka, 1229, Bangladesh; 2Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India; 3Department of Anatomy, University of Ilorin, Nigeria; 4Department of Pharmacy, University of Dhaka, Dhaka, Bangladesh; 5Department of Microbiology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, 10700, Thailand; 6Department of Nutrition and Food Science, University of Dhaka, Dhaka, Bangladesh; 7Department of Physiology, Eastern Medical College, Cumilla, Bangladesh; 8Department of Pharmacognosy, BVM College of Pharmacy, Gwalior, India; 9Department of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Bayero University, Kano, Nigeria; 10Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka, Anambra State, Nigeria; 11Department of Microbiology, Jahangirnagar University, Savar, Dhaka, Bangladesh; 12Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, MalaysiaCorrespondence: Mainul HaqueUnit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur, 57000, MalaysiaTel +60109265543Email runurono@gmail.comAbstract: The outbreak of pneumonia caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), later named COVID-19 by the World Health Organization (WHO), was initiated at Wuhan, Hubei, China, and there was a rapid spread of novel SARS-CoV-2 and the disease COVID-19 in late 2019. The entire world is now experiencing the challenge of COVID-19 infection. However, still very few evidence-based treatment options are available for the prevention and treatment of COVID-19 disease. The present review aims to summarize the publicly available information to give a comprehensive yet balanced scientific overview of all the fat-soluble vitamins concerning their role in SARS-CoV-2 virus infection. The roles of different fat-soluble vitamins and micronutrients in combating SARS-CoV-2 infection have been recently explored in several studies. There are various hypotheses to suggest their use to minimize the severity of COVID-19 infection. These vitamins are pivotal in the maintenance and modulation of innate and cell-mediated, and antibody-mediated immune responses. The data reported in recent literature demonstrate that deficiency in one or more of these vitamins compromises the patients’ immune response and makes them more vulnerable to viral infections and perhaps worse disease prognosis. Vitamins A, D, E, and K boost the body’s defense mechanism against COVID-19 infection and specifically prevent its complications such as cytokine storm and other inflammatory processes, leading to increased morbidity and mortality overemphasis. However, more detailed randomized double-blind clinical pieces of evidence are required to define the use of these supplements in preventing or reducing the severity of the COVID-19 infection.Keywords: SARS-CoV-2, COVID-19, fat-soluble vitamins, micronutrients, immune response

Adekunle Babajide Rowaiye,1 Okiemute Ajiroghene Okpalefe,2 Olukemi Onuh Adejoke,3 Joyce Oloaigbe Ogidigo,4 Oluwakemi Hannah Oladipo,5 Amoge Chidinma Ogu,3 Angus Nnamdi Oli,1 Samson Olofinase,2 Onyekachi Onyekwere,6 Abdullahi Rabiu Abubakar,7 Dilshad Jahan,8 Salequl Islam,9 Siddhartha Dutta,10 Mainul Haque11 1Department of Pharmaceutical Microbiology and Biotechnology, Faculty of Pharmaceutical Sciences, Nnamdi Azikiwe University, Awka, Anambra State, Nigeria; 2Department of Genetics, Genomics, Bioinformatics, National Biotechnology Development Agency, Abuja, Nigeria; 3Department of Medical Biotechnology, National Biotechnology Development Agency, Abuja, Nigeria; 4Bioresources Development Centre, Abuja, National Biotechnology Development Agency, Abuja, Nigeria; 5Bioresources Development Centre, Ilorin, National Biotechnology Development Agency, Kwara State, Nigeria; 6Bioresources Development Centre, Ubulu-Uku, National Biotechnology Development Agency, Delta State, Nigeria; 7Department of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Bayero University, Kano, 700233, Nigeria; 8Department of Hematology, Asgar Ali Hospital, Gandaria, Dhaka, 1204, Bangladesh; 9Department of Microbiology, Jahangirnagar University, Savar, Dhaka, 1342, Bangladesh; 10Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India; 11Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur, 57000, MalaysiaCorrespondence: Mainul HaqueUnit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur, 57000, MalaysiaTel +60109265543Email runurono@gmail.comAbstract: The COVID-19 pandemic constitutes an arduous global health challenge, and the increasing number of fatalities calls for the speedy pursuit of a remedy. This review emphasizes the changing aspects of the COVID-19 disease, featuring the cytokine storm’s pathological processes. Furthermore, we briefly reviewed potential therapeutic agents that may modulate and alleviate cytokine storms. The literature exploration was made using PubMed, Embase, MEDLINE, Google scholar, and China National Knowledge Infrastructure databases to retrieve the most recent literature on the etiology, diagnostic markers, and the possible prophylactic and therapeutic options for the management of cytokine storm in patients hospitalized with COVID-19 disease. The causative agent, severe acute respiratory coronavirus-2 (SARS-CoV-2), continually threatens the efficiency of the immune system of the infected individuals. As the first responder, the innate immune system provides primary protection against COVID-19, affecting the disease’s progression, clinical outcome, and prognosis. Evidence suggests that the fatalities associated with COVID-19 are primarily due to hyper-inflammation and an aberrant immune function. Accordingly, the magnitude of the release of pro-inflammatory cytokines such as interleukin (IL)-1, (IL-6), and tumor necrosis alpha (TNF-α) significantly differentiate between mild and severe cases of COVID-19. The early prediction of a cytokine storm is made possible by several serum chemistry and hematological markers. The prompt use of these markers for diagnosis and the aggressive prevention and management of a cytokine release syndrome is critical in determining the level of morbidity and fatality associated with COVID-19. The prophylaxis and the rapid treatment of cytokine storm by clinicians will significantly enhance the fight against the dreaded COVID-19 disease.Keywords: COVID-19, SARS-CoV-2, cytokine storm, hyper-inflammation, fatality

Nandeeta Samad,1 Temitayo Eniola Sodunke,2 Abdullahi Rabiu Abubakar,3 Iffat Jahan,4 Paras Sharma,5 Salequl Islam,6 Siddhartha Dutta,7 Mainul Haque8 1Department of Public Health, North South University, Dhaka, 1229, Bangladesh; 2Department of Anatomy, University of Ilorin, Ilorin, Kwara State, Nigeria; 3Department of Pharmacology and Therapeutics, Faculty of Pharmaceutical Sciences, Bayero University, Kano, 700233, Nigeria; 4Department of Physiology, Eastern Medical College, Cumilla, Bangladesh; 5Department of Pharmacognosy, BVM College of Pharmacy, Gwalior, India; 6Department of Microbiology, Jahangirnagar University, Dhaka, 1342, Bangladesh; 7Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India; 8The Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, MalaysiaCorrespondence: Mainul HaqueUnit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur, 57000, MalaysiaTel +60 10 926 5543Email runurono@gmail.comAbstract: The global pandemic from COVID-19 infection has generated significant public health concerns, both health-wise and economically. There is no specific pharmacological antiviral therapeutic option to date available for COVID-19 management. Also, there is an urgent need to discover effective medicines, prevention, and control methods because of the harsh death toll from this novel coronavirus infection. Acute respiratory tract infections, significantly lower respiratory tract infections, and pneumonia are the primary cause of millions of deaths worldwide. The role of micronutrients, including trace elements, boosted the human immune system and was well established. Several vitamins such as vitamin A, B6, B12, C, D, E, and folate; microelement including zinc, iron, selenium, magnesium, and copper; omega-3 fatty acids as eicosapentaenoic acid and docosahexaenoic acid plays essential physiological roles in promoting the immune system. Furthermore, zinc is an indispensable microelement essential for a thorough enzymatic physiological process. It also helps regulate gene-transcription such as DNA replication, RNA transcription, cell division, and cell activation in the human biological system. Subsequently, zinc, together with natural scavenger cells and neutrophils, are also involved in developing cells responsible for regulating nonspecific immunity. The modern food habit often promotes zinc deficiency; as such, quite a few COVID-19 patients presented to hospitals were frequently diagnosed as zinc deficient. Earlier studies documented that zinc deficiency predisposes patients to a viral infection such as herpes simplex, common cold, hepatitis C, severe acute respiratory syndrome coronavirus (SARS-CoV-1), the human immunodeficiency virus (HIV) because of reducing antiviral immunity. This manuscript aimed to discuss the various roles played by zinc in the management of COVID-19 infection.Keywords: zinc therapy, microelement, immune-boosting, efficacy, COVID-19, viral infections, pneumonia, pandemic

Rimple Jeet Kaur,1 Jaykaran Charan,2 Siddhartha Dutta,2 Paras Sharma,3 Pankaj Bhardwaj,4 Praveen Sharma,5 Halyna Lugova,6 Ambigga Krishnapillai,7 Salequl Islam,8 Mainul Haque,9 Sanjeev Misra10 1Department of Pharmacology, Dr. S.N Medical College, Jodhpur, Rajasthan, India; 2Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India; 3Department of Pharmacognosy, BVM College of Pharmacy, Gwalior, India; 4Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India; 5Department of Biochemistry, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India; 6The Unit of Community Medicine, Faculty of Medicine and Defence Health, National Defence University of Malaysia, Kuala Lumpur; 7Family Medicine, Faculty of Medicine and Defence Health, National Defence University of Malaysia; 8Department of Microbiology, Jahangirnagar University, Savar, Dhaka 1342, Bangladesh; 9The Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan, Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia; 10All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, IndiaCorrespondence: Mainul HaqueThe Unit of Pharmacology, Faculty of Medicine and Defence Health, Universiti Pertahanan, Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur 57000, MalaysiaTel +60109265543Email runurono@gmail.comBackground: COVID-19 caused by SARS-CoV-2 virus emerged as an unprecedented challenge to discover effective drugs for its prevention and cure. Hyperinflammation-induced lung damage is one of the poor prognostic indicators causing a higher rate of morbidity and mortality of COVID-19 patients. Favipiravir, an antiviral drug, is being used for COVID-19 treatment, and we currently have limited information regarding its efficacy and safety. Thus, the present study was undertaken to evaluate the adverse drug events (ADEs) reported in the WHO pharmacovigilance database.Methods: This study analyzed all suspected ADEs related to favipiravir reported from 2015. The reports were analyzed based on age, gender, and seriousness of ADEs at the System Organ Classification (SOC) level and the individual Preferred Term (PT) level.Results: This study is based on 194 ADEs reported from 93 patients. Most frequent ADEs suspected to be caused by the favipiravir included increased hepatic enzymes, nausea and vomiting, tachycardia, and diarrhea. Severe and fatal ADEs occurred more frequently in men and those over the age of 64 years. Blood and lymphatic disorders, cardiac disorders, hepatobiliary disorders, injury poisoning, and procedural complications were more common manifestations of severe ADEs.Conclusion: This study revealed that favipiravir appears to be a relatively safe drug. An undiscovered anti-inflammatory activity of favipiravir may explain the improvement in critically ill patients and reduce inflammatory markers. Currently, the data is based on very few patients. A more detailed assessment of the uncommon ADEs needs to be analyzed when more information will be available.Keywords: favipiravir, usage, SARS-Cov-2, scrutiny, assumed, adverse drug events, described, World Health Organization, record

Siddhartha Dutta,1 Rimplejeet Kaur,2 Mainul Haque,3 Pankaj Bhardwaj,4 Deepak Saxena,5 Nor Azlina A Rahman,6 Halyna Lugova,7 Dilshad Jahan,8 Salequl Islam,9 Tajkera Sultana Chowdhury,10 Jaykaran Charan1 1Department of Pharmacology, All India Institute of Medical Sciences, Jodhpur, Rajasthan, India; 2Department of Pharmacology, Dr. S.N Medical College, Jodhpur, Rajasthan, India; 3The Unit of Pharmacology, Faculty of Medicine and Defence Health Universiti Pertahanan, Nasional Malaysia (National Defence University of Malaysia), Kuala Lumpur, Malaysia; 4Department of Community and Family Medicine, All India Institute of Medical Sciences (AIIMS), Jodhpur, Rajasthan, India; 5Indian Institute of Public Health (IIPH) Gandhinagar, Gujarat, India; 6Department of Physical Rehabilitation Sciences, Kulliyyah of Allied Health Sciences, International Islamic University Malaysia, Kuantan, Malaysia; 7The Unit of Community Medicine, Faculty of Medicine and Defence Health, National Defence University of Malaysia, Kuala Lumpur, Malaysia; 8Department of Hematology, Gandaria Beside Dhupkhola, Asgar Ali Hospital Ltd, Dhaka, 1204, Bangladesh; 9Department of Microbiology, Jahangirnagar University, Savar, Dhaka 1342, Bangladesh; 10Department of Urology, Shaheed Suhrawardy Medical College Hospital, Dhaka 1207, BangladeshCorrespondence: Mainul HaqueThe Unit of Pharmacology, Faculty of Medicine and Defence Health Universiti Pertahanan, Nasional Malaysia (National Defence University of Malaysia), Kem Perdana Sungai Besi, Kuala Lumpur 57000, MalaysiaTel +60 109265543Email runurono@gmail.comBackground: Clinical Trial Registry - India (CTRI) is a valuable tool to access information regarding clinical trials conducted in India. To serve this purpose, the information provided on it must be complete and accurate. The present study was designed to assess the reasons for premature termination of clinical trials on the CTRI database and determine the average timings related to updating information on CTRI.Methods: The data were extracted from the website of Clinical Trial Registry - India; all the terminated trials from 20 July 2007 to 18 December 2019 were included. The reasons given for termination were categorized as scientific reasons, nonscientific reasons, and unspecified reasons.Results: Of 16,579 interventional clinical trials, 243 trials were terminated. Out of these 243 trials, reasons were given in 50 (20.58%). In reasoning with scientific data, the most common reason was safety issues (14%), and among nonscientific data, a significant delay in recruitment was a principal reason (16%). The median time from date of registration to date of modification was 1034 days (0– 3912), and the median time from the date of last revision to the date of our analysis was 1329 days (2– 3138).Conclusion: The reasons for termination are not mentioned adequately for the terminated clinical trials in the Clinical Trial Registry of India. Efforts need to be done to motivate investigators to report the reasons for termination. Proper planning of trial before initiation may prevent premature termination of clinical trials and ensure fair use of resources.Keywords: Clinical Trial Registry of India, terminated trials, reasons for premature termination