The sudden onset of the COVID-19 pandemic in 2020 provided a serious challenge to the Foundation's work. Its identity as a biomedical and public health research organization pushed us to take up this challenge. The unique mask-based method developed at FMR for TB diagnosis was modified to capture expelled viral particles and project risk of transmission. Genome sequencing expertise was translated to analyze the characteristics of circulating variants. Simultaneously, we initiated clinical trials to evaluate usefulness of vitamin D and Zinc supplementation for reducing serious outcomes in COVID-19. In 2021, as the vaccination drive unfolded and simultaneously Delta variant ravaged the country, we turned to address important questions about breakthrough infections- what were the characteristics of these variants that caused breakthrough infections and did vaccination have the potential to reduce transmission. Now as the pandemic appears to be retreating, but with the resurgence threat still looming, we have now focused our attention to wastewater surveillance of the virus intending to predict potential oncoming waves.
Some key achievements in this period have been
- Demonstrating a technology for gauging transmission of COVID-19
- Deciphering the impact of vaccination on transmission risk and strain patterns of the virus in order to generate evidence related to breakthrough infections
Dr. Kayzad Nilgiriwala
1. Dr. Mangala D. Gomare, Municipal Corporation of Greater Mumbai
2. Dr. Daksha Shah, Municipal Corporation of Greater Mumbai
Ms. Tejal Mestry, Ms. Grishma Patel, Mr. Nilesh Shahasne, Ms Pratibha Kadam
Science and Engineering Research Board
July 2022 – June 2023
INR 44 lakhs
This project aims to undertake periodic genomic surveillance for SARS-CoV-2 variants in effluents in urban localities with a vulnerable population. The emergence of any new mutations/variants in the vulnerable communities in Mumbai through comparison with the local and global database of mutations will also be conducted. The biological significance of specific trends of mutations with respect to transmission, immune evasion and viral load will be assessed. This will lead to a better understanding of the sustainability of targeted environmental surveillance for the detection of known and newly emerging variants in vulnerable populations. It will also serve as a warning system for subsequent waves of SARS-CoV-2 infection.
In this project, the effluent/wastewater samples from 8 sites located in slum areas (Dharavi, Kherwadi, Beharampada in Bandra East and Sidharth Nagar in Worli) will be collected twice weekly for 10 months from the selected slum areas. The wastewater/sewage will be processed for RNA isolation, and RT-qPCR will be conducted to determine the viral load. Sequencing will be undertaken in 10% of the positive environmental samples. Data processing and analyses will be focused on periodic surveillance / new mutations or variants / biological significance of new mutations.
1. Dr. Kevin Kain, University of Toronto, Canada
2. Dr. Wafaie Fawzi, Harvard School of Public Health, USA
3. Dr. Yatin Dholakia
Dr. Nerges Mistry
1. Dr. Pradeep D’Costa, King Edward Memorial (KEM) Hospital and Research Center, Pune
2. Dr. Gaurav Gupta, Saifee Hospital, Mumbai
Mr. Kamalkant Sharma, Ms. Sanaa Shaikh, Mr. Yogesh Marathe (FMR); Dr. Vrushali Patil, Dr.Rohit Kumar, Dr. Bhushan Labhane, Ms. Deepa Patil, Ms. Komal Dalvi, Ms. Priti Vidhate (KEM); Dr. Sashidhar, Dr. Atmashakti, Ms. Latika Raju Mhatre, Ms. Janhvi Jitendra Shelatkar (Saifee)
Canadian Institute of Health Research, Canada
October 2020 –October 2022
INR 368 lakhs
Micronutrient deficiencies, particularly vitamin D and zinc, are associated with impaired host-immune response and may play important roles in COVID-19. While supplementation is important in the context of other infections, there are no well-designed studies on the potential effects of such supplements on COVID-19. A randomized, placebo-controlled trial using a 2x2 factorial was designed to examine individual effects of vitamin D or zinc supplements as immune-based therapy among 700 COVID-19 patients in India. Eligible participants included non-pregnant women or men >18 years with PCR-confirmed infection, recruited from KEM Hospital, Pune and Saifee Hospital, Mumbai. The unpredictability of COVID-19 waves was a challenge to the study to maintain recruitment during periods where cases were declining. Early anticipation of the scenario led to a modification of enrollment criteria.
Interventions: Patients randomized to 8 weeks of (1) Vitamin D (180,000 IU bolus followed by 2000 IU daily); (2) Zinc (daily doses of 40 mg); (3) Vitamin D + Zinc; or (4) Placebo.
Primary Aims: To determine the effect of vitamin D and/or zinc supplementation versus placebo on time to recovery among patients with COVID-19.
Secondary Aims: To determine the effect of vitamin D or zinc supplementation on all-cause mortality, duration of hospital stay, the necessity for assisted ventilation, individual symptoms duration, change in inflammatory and immunologic biomarkers levels.
A total of 409 patients (average age of 47 years) were screened between April 2021 to January 2022. Of these, 181 were recruited and randomized to the 4 arms. Significantly, 48.6% of the screened patients refused to consent to participate.
At this stage of the Project, the data is still blinded and awaits decoding for analysis. However, our baseline analysis shows
Two research studies were conducted in parallel with interlinked objectives and common funding.
Dr. Kalpana Sriraman
1. Dr. Nerges Mistry, Dr. Ambreen Shaikh, Dr. Kayzad Nilgiriwala
2. Dr. Vikas Oswal, Vikas Nursing Home, Mumbai
3. Dr. Mangala D. Gomare, Municipal Corporation of Greater Mumbai
4. Dr. Daksha Shah, Municipal Corporation of Greater Mumbai
1. Dr. Nerges Mistry
2. Dr. Zarir Udwadia ,Breach Candy Medical Research Centre (BCMRC), Mumbai
1. Dr. Kayzad Nilgiriwala, Dr Kalpana Sriraman, Dr. Ambreen Shaikh, FMR
2. Dr. Aruna Poojary , BCMRC
3. Dr. Bhavesh Gandhi , BCMRC
1. Ms. Smriti Vaswani, Ms. Tejal Mestry, Ms. Grishma Patel, Ms. Pratibha Kadam
2. Ms. Niharika Shinde; Dr. Seema Kukreja, BCMRC
Members of HBS Alumni Club of India, General donation of Zoroastrian Charity Trust of Hong Kong
June 2021– April 2022
INR 46 lakhs
Vaccines are the most potent weapon we have for controlling the COVID-19 pandemic. Although the efficacy of current vaccines was well established, there was increasing concern in India in early 2021 about COVID-19 infection despite vaccination. The incidence of infection post-vaccination raised several questions- why were some people susceptible despite vaccination, do they get infected with the mutated virus not protected by the vaccine and do vaccinated individuals transmit the virus? It was important to address these clinical research gaps more systematically to guide disease control efforts.
Study 1 aimed to a) to assess the transmission risk from vaccinated COVID-19 positive individuals using adapted N-95 mask sampling and investigate its relationship to SARS-CoV-2 specific antibody responses b) to characterize the strains in infections acquired after partial or full COVID-19 vaccination by whole genome sequencing in home isolated patients with mild disease. The study prospectively followed up vaccinated and unvaccinated 95 COVD-19 patients who were primarily home isolated with mild disease in Mumbai region between June and September 2021. Mask, swab, and blood samples were collected from these patients at two time points- within 48 hours of diagnosis and between 8-12 days of symptom onset. Mask and swab samples were analyzed by RT-PCR for viral RNA and blood was evaluated for SARS-CoV-2 anti-spike and nucleocapsid antibody responses. Whole genome sequencing of swab samples was also carried out to understand the mutations and strain characteristics of the infected strains.
Study 2 aimed to genomically characterize the strains from fully vaccinated mild to severe hospitalized patients with breakthrough infections and investigate the association between SARS-CoV-2 specific antibody responses and genome characteristics. The study recruited 74 mild to severe fully vaccinated COVID-19 patients from Breach Candy Hospital between June – Dec 2021. Nasopharyngeal swab and blood samples collected from these patients were subjected to RT-PCR, whole genome sequencing and antibody testing.
Transmission risk analysis (Study 1)
Genome Analysis (Study 1 & 2)
Dr. Nerges Mistry
Dr. Kalpana Sriraman, Dr. Kayzad Nilgiriwala, Dr. Ambreen Shaikh
Dr. Jayanthi Shastri, Kasturba Hospital for Infectious Diseases, Mumbai
Ms. Smriti Vaswani, Ms. Tejal Mestry, Mr. Nilesh Shahasne (FMR)
Dr. Swapneil Parikh, Dr. Shreevatsa Udupa, Dr. Nirjhar Chatterjee, Dr. Meet Visaria and Dr. Aishvarya Singh, (Kasturba Hospital)
Grants and donations from Godrej Agrovet Limited-Mumbai, Zoroastrian Charity Funds of Hong Kong, Canton and Macao, and The Vasketu Foundation, Mumbai
June 2020 – November 2020
INR 18.2 lakhs
The project investigated the potential of aerosols expelled/exhaled by COVID-19 patients and captured on a modified mask as a diagnostic tool and for studying viral genomics. This was a pilot study wherein mask based detection of COVID-19 was evaluated against concomitantly collected nasopharyngeal swabs in 31 patients who were confirmed to have COVID-19 and an equal number of healthy volunteers.