The Mwanza Intervention Trials Unit (MITU) based at the National Institute for Medical Research (NIMR) campus in Mwanza, (Tanzania) is a collaborative research unit of NIMR and the London School of Hygiene and Tropical Medicine (LSHTM). MITU’s mission is to contribute to improving health through the development and evaluation of interventions against HIV and other health problems by conducting research, including clinical trials, to the highest international standards; to enhance the capacity to carry out such research in Tanzania and the East African region; and to contribute to the translation of research findings into health policy.
MITU, in collaboration with LSHTM and five other African institutional partners, is part of the ENTRANT training fellowship programme which seeks to develop a critical mass of infectious disease epidemiologists to work with the Ministries of health and their academic and research partners, to prevent and respond to emerging outbreaks and public health emergencies. The programme, funded by the European & Developing Countries Clinical Trials Partnership (EDCTP), will support 15 African scientists over two academic years (2021-2023) to complete a one-year full-time MSc degree in Epidemiology at the LSHTM. At least two fellows will be from Tanzania. In addition to the MSc taught courses, fellows will also complete an LSHTM short- course on pandemic preparedness, response and research led by members of the Uk Public Health Rapid Support Team (UK-PHrSt) and a three-month MSc research project carried out in Tanzania.
The other African institutional partners collaborating in this consortium are:
- National Health Laboratory (NHL), Botswana
- Haramaya University (HU), Ethiopia
- University of Nairobi (UoN), Kenya
- MRC/UVRI & LSHTM Uganda Research Unit (MUL), Uganda
- ZAMBART Project Limited, Zambia
Eight places are available for 2021-22 academic year and each fellowship includes:
- 2021-22 tuition fees (at the overseas fee rate)
- Stipend (living allowance) of £16,800
- Return air travel to London
- An allowance for MSc research project expenses
- Support to attend conferences and networking events after completion of the MSc
To be eligible, candidates must:
a) Be a resident and national of Tanzania.
b) Hold a minimum of an upper second-class honours degree from a reputable university in Tanzania or other countries, or a registerable qualification in medicine, dentistry or veterinary medicine.
c) Be working with either the Ministry of Health, Community Development, Gender, Elderly and Children or at the Institutes of Public Health at Muhimbili University of Health and Allied Sciences (MUHAS), and Catholic University Health and Allied Sciences (CUHAS) or School of Public Health at Kilimanjaro Christian Medical College (KCM college), or Research Institutes at the National Institute for Medical Research (NIMR),Ifakara Health Institute (IHI) and Kilimanjaro Christian Research Institute (KCRI) or at the University of Dodoma. Applicant employer will need to provide a letter of support guaranteeing that the fellow will be released from work commitments for the full one-year period of the MSc, and that the fellow’s post or an equivalent role will be available for them to return to following completion of their studies. The letter should also express support for the fellow to have protected time (recommended one day per week for a 10-week period) to undertake the pandemic short course following the MSc.
d) Have at least 2 years and less than 15 years’ full-time equivalent work experience since completion of their first degree.
e) Be able to meet English language requirements for the LSHTM MSc Epidemiology specified here https://www.lshtm.ac.uk/sites/default/files/english language requirements policy.pdf
f) Be committed to continue working as a public health practitioner in Tanzania for a minimum of two years after completing their studies.
How to apply:
The online application system includes a personal statement section. Candidates should use this section to give further details on their current role in public health and how they will be in a position to contribute to public health activities and disease outbreak preparedness and response activities following completion of the MSc. They should also set out their commitment to remain working as a public health practitioner in Tanzania for a minimum of two years after completing their studies.
Documents that must be uploaded as part of the application are listed below:
- Curriculum vitae
- Academic transcript
- Letter of support from current employer, including the information specified in point c) above.
Applications received after the closing date will not be considered. Shortlisted candidates will be interviewed via Zoom.
Support will not be given as a supplement to other funding, nor to students who have funding from other sources.
Find out more about the MSc in Epidemiology.
Informal enquiries concerning the MSc can be made to the Programme Directors.
Find out more about visa requirements.
Gender-based violence is prevalent globally.
It occurs in many forms, including intimate partner violence, rape and coerced sex, child sexual abuse, and human trafficking. Such forms of gender-based violence are significant risk factors for poor health, impacting on individuals’ physical, sexual and psychological health, as well as their social and economic well-being.
Evidence from rigorously conducted research is essential to ensuring that policies and services to prevent and respond to violence are well-designed and appropriate to the context where women, children, adolescents and men live. Conducting action-oriented research on gender-based violence that is robust and carried out in ethical and safe ways requires specific methodological approaches.
This course aims to strengthen participants’ knowledge and skills to conduct or commission technically rigorous, ethical and policy- and service-relevant research on various forms of violence against women, children and adolescents.
It is intended for individuals who will conduct or commission research on gender-based violence. It will be of particular interest to those who want to add a ‘violence component’ to a study that is quantitative or qualitative or an intervention evaluation.
It is relevant for individuals working on health-related topics such as sexual and reproductive health, maternal health, HIV, mental health and substance use.
The course will be taught through a series of online interactive lectures, practical exercises, group work and assigned reading.
The course will cover topics including:
- Conceptualising and researching various forms of gender-based violence
- Associations between violence and health: current knowledge
- Ethics and safety
- Approaches to researching violence: qualitative, quantitative, mixed methods, intervention research
- Developing conceptual frameworks for violence and health research
- Survey research on violence and questionnaire design
- Intervention research: approaches and challenges
- Violence research in health care settings
- Violence research in humanitarian settings
Dr Karen Devries, Dr Cathy Zimmerman and Dr Ana Maria Buller
The course will also feature lectures from Prof Charlotte Watts and visiting staff from other universities.
Duration: 17-28 May 2021
Fees for 2021: £850
Contact email: email@example.com
Find out more and apply: www.lshtm.ac.uk/study/short-courses/gender-violence
Position: Female Research Assistant
Ref. Number: MITU/RA/1/21
The Mwanza Intervention Trials Unit (MITU) based at the National Institute for Medical Research (NIMR) campus in Mwanza, (Tanzania) is a collaborative research unit of the London School of Hygiene and Tropical Medicine and NIMR. MITU’s mission is to contribute to improving health through the development and evaluation of interventions against HIV and other health problems by conducting research, including clinical trials, to the highest international standards; to enhance the capacity to carry out such research in Tanzania and the East African region; and to contribute to the translation of research findings into health policy.
Adolescent 360 (A360) is a programme that aims to increase voluntary modern contraceptive use and reduce unplanned pregnancy among young women aged 15-19 years old in Ethiopia, Tanzania and Nigeria. MITU is collaborating with other research partners to conduct an endline survey to investigate the history, knowledge and use of family planning methods among young women aged 15-19 years old in Mwanza region, Tanzania. The study will be conducted in 15 wards in the Ilemela district in Mwanza city. MITU is inviting applications from young women to participate as Research Assistants in the study.
Location: Ilemela district, Mwanza
Reporting to: Study Coordinator and Field Coordinator
Duration of assignment: April 2021 – June 2021
Starting date: 01 April 2021
- Conduct informed consent procedures with study participants prior to conducting the interviews.
- Conduct structured face-to-face interviews with participants and record responses in tablet computers and other paper-based forms.
- Assure participant safety and confidentiality during data collection.
- Manage and safeguard data collection tools e.g. tablets.
- Prepare weekly progress reports to share with the study management team.
- Participate in regular field team debriefing meetings.
- Perform other tasks as needed by supervisors.
- Applicants must be women aged between 18 to 27 years of age.
- At least a degree or equivalent in a relevant field to the study topic.
- Good written and oral communication in English and Kiswahili.
- Experience in conducting structured, face to face interviews.
- Able to work on flexible schedule, including weekends and after normal working hours.
- Ability to work effectively with minimal supervision and adhere to set priorities, standards and deadlines.
- Ability to work as part of a team.
- Experience in the use of tablets in data collection.
- Experience with working with adolescent young girls.
- Application letter should be written in English.
- Applicants much attach relevant copies of their academic certificates.
- Applicants must attach their curriculum vitae (CV). CVs should have a daytime mobile number, email address of the applicant and contacts of two referees.
- Only shortlisted candidates will be contacted.
- Closing date for applications is 25 March 2021.
Mode of Application
Those who meet the criteria should send their application letter with the heading “A360
RESEARCH ASSISTANT” and required documentation to firstname.lastname@example.org
Results from this study highlight the importance of maintaining and increasing vaccine coverage to sustain gains made in reducing deaths related to infectious diseases in low-and middle-income countries.
In recent years, handwashing with soap has been gaining recognition as an important practice for maintaining good health. Many international organisations, including the World Health Organization (WHO), have taken part in promoting regular handwashing with soap. This is mainly because current scientific evidence shows that handwashing with soap reduces transmission of infectious agents and is an effective means to prevent infections.
Since the effectiveness of handwashing is well-established, the scientists at the Mwanza Intervention Trials Unit (MITU) are working to include this practice as part of a package of public interventions aiming to combat worm infections among primary school children in Kagera region, northwestern Tanzania. Recently, Dr. Kenneth Makata and his colleagues published an article in PlosOne that describes their work, which uses handwashing with soap as a tool to reduce the burden of common worm infections (namely Ascaris lumbricoides and Trichuris trichiura) in the study population. This article presents results of a survey which was conducted before the implementation of a large study aiming to assess the effectiveness of a range of measures, including handwashing with soap, in reducing the chance of getting new worm infections following mass treatment of school children.
It is interesting to note the innovation that goes into the design of this research project. Dr. Makata and his colleagues installed handwashing facilities close to the latrine building in 8 primary schools taking part in this study in 3 districts of Kagera region.
Each facility had replenishable pieces of soap to be used. The team also painted the pathways linking latrines and handwashing facilities to make them look friendly and to sub-consciously motivate the school children to use the facilities to wash hands. Teacher-led classroom teaching and sessions to involve parents were also provided as part of the package.
“We were very pleased to see school children highly motivated to use the facilities after their installations,” said Dr. Makata who coordinated all activities related to this study in Kagera. “Our study confirms that worm infections among school children are a major health problem in Kagera region”. Results of the main study have been submitted for publication.
The Mwanza Intervention Trials Unit (MITU) based at the National Institute for Medical Research (NIMR) campus in Mwanza, Tanzania is a collaborative research unit of NIMR and the London School of Hygiene and Tropical Medicine. The mission of MITU is to contribute to improving health through the development and evaluation of interventions against infections and other health problems by conducting research, including clinical trials, to the highest international standards. MITU also aims to enhance the capacity to carry out such research in Tanzania and to contribute to the translation of research findings into health policy. The Unit is now inviting applications from motivated and suitably qualified candidates to fill the following position that will be based at NIMR campus, Mwanza.
Position: Senior Finance Officer
Ref. Number: MITU/FIN/01/21
We are seeking to appoint an ambitious and highly motivated senior finance officer with proven technical experience in accounting and financial management, who is capable of working under the supervision of the Associate Director of Finance and Administration as part of the finance team of MITU.
- Be responsible for managing all finance aspects of various projects, including preparing quarterly management accounts and providing day-to-day advice, guidance and support to MITU’s Principal Investigators (PI’s) and Project Co-ordinators (PC’s).
- Maintain and update MITU’s financial systems and controls, verifying and checking the financial records, reports, ledgers and statements.
- To support with the preparation of audit files during audits, liaise with staff and auditors during the process and help prepare supporting documentations and the production of audited annual accounts.
- To be responsible for the processing of sales invoices for grants and other income sources, thereby ensuring that all monies are received and banked accordingly.
- To maintain appropriate computerised and paper filing systems of financial information in accordance with MITU’s process and procedures.
- To manage the MITU fixed asset register in collaboration with the procurement team, thereby ensure that this is fully updated.
- To assist Investigators during proposal budget preparation and to also help with setting up of budgets within the MITU finance systems.
- To assist with the monthly payroll, including the reviewing of overtime claims forms and ensure that all overtime claims are accurate and in line with MITU’s processes and procedures.
- To provide financial information and advice to other MITU colleagues as and when required.
- To liaise with MITU senior staff and collaborating institutions on any administrative issues.
- Promote MITU, its core values and services, and play a positive role in the delivery of its day-to-day operations and strategic goals.
- To carry out other duties relevant to the post as and when requested.
Essential criteria for selection
- A relevant accounting qualification, degree in Accounting, Finance, Business Administration or a professional accounting qualification (CPA/ACCA or equivalent).
- A minimum of 5 years experience working within a similar organisation preparing management accounts using computerised software packages.
- Excellent financial software knowledge such as ERP Navision, SUN, QuickBooks.
- Excellent financial report-writing skills and the ability to communicate financial information easily to be understood and in a clear format.
- Proven experience of preparing and monitoring budgets and financial reports.
- Strong organisational skills with proven ability to work effectively within a team, assess priorities and manage workload with minimum supervision.
- Proven experience of good written and oral communication skills in English.
- Experience of managing restricted/unrestricted income and expenditure accounting and reporting.
- Experience of managing grants from international Donor such as DFID, ERC, MRC, USAID etc.
- Self-motivation and effective time management skills.
- Excellent communication and interpersonal skills.
Desirable criteria for selection
- Experience of working within the development sector e.g., Non-governmental Organisations (INGO’s or NGO).
- Experience of working within a Research Institution/Organisation.
MODE OF APPLICATION
E-mail applications to email@example.com with the following:
- Detailed supporting statement/letter – Whereby each section should set out how your qualifications, experience and skills meet each of the essential and desirable criteria within the person specification. Please provide one or more paragraphs addressing each criterion. The supporting statement is an essential part of the selection process and thus a failure to provide this information will mean that the application will not be considered. An answer to any of the criteria such as “Please see attached CV” will not be considered acceptable.
- Please include a daytime mobile telephone number and e-mail contact details.
- Curriculum vitae (CV) including names and addresses of two referees (one must be from your most recent employer or training institution).
CLOSING DATE FOR APPLICATION
- Applications received later than 26th February 2021 will not be considered.
- You will be informed by email if selected for interview and only shortlisted candidates will be contacted.
- Interviews will be held in the following weeks at the NIMR Mwanza Centre, Isamilo, Mwanza or remotely through zoom or other online platform.
According to studies, intimate partner violence – defined as physical, sexual or psychological harm by a current or former partner or spouse – is the most common form of violence experienced by women in relationships throughout the world. It is estimated that about one in every three women worldwide will experience physical or sexual violence from an intimate partner during their lifetime.
This high rate of violence against women needs special attention, and it can’t be ignored. Luckily, Dr. Shelley Lees and her colleagues at Mwanza Intervention Trials Unit (MITU) and the London School of Hygiene over the past 10 years have been working to find a solution to this common problem among women. This involves women attending in groups ten gender training sessions which were held in a convenient location within their community. This training was aimed to help them gain skills and knowledge to challenge physical and/or sexual violence from their male partners.
Recently, Dr. Lees and colleagues published part of their continuing work in the Journal of Culture, Health & Sexuality. This report provides information which helps to understand how gender training is helping women to change their attitudes and overcome violence. The study interviewed a subset of women who participated in a large trial implemented by MITU (called the MAISHA trial) to find out if it is possible to reduce violence among women in Mwanza city, Tanzania. From women’s views, gender training, which seeks to develop political awareness and transformation, can promote change amongst participants through a collective learning process. And this change brings a sense of confidence, worth, and power among women who participated in gender training to enable them to challenge violence.
The findings from this study bring hope to the fight to end violence against women in Tanzania.
Menstruation – the monthly genital bleeding experienced by women after reaching puberty – is a big problem among school girls in many parts of the world. Girls generally feel shame when the bleeding leaks on their school uniforms, get laughed at or teased by boys, lack soap, water or private places to change, clean or dry menstrual pads, or lack ways to reduce pains while at school. These problems have been reported to limit girl‘s participation in some school activities that require to stand or walk to the front of the class to answer a question or demonstrate something. They also cause girls to leave school early, miss some classes, stay at home during the days they are bleeding or leave school for good before the end of their school years.
MITU has received funds from the UK Medical Research Council (MRC) to carry out this study that will help address the problems related to menstruation and contribute in improved reproductive health.
Dr Elialilia Okello, a senior MITU research scientist, is leading this three-year study which will take place in eight secondary schools in Mwanza and Kilimanjaro regions. MITU will be implementing this study together with Femme International, a local non-governmental organisation working in Tanzania; the London School of Hygiene & Tropical Medicine, UK; and local government leaders in the two regions.
The study has three main stages. The first stage is the review of a health education programme implemented by Femme International and develop a plan to bring on board boys and local government leaders in the programme. This will help the boys and the leaders to understand issues related to menstruation and offer their support to girls during that period instead of laughing or teasing them. The study will recommend ways of giving out reusable sanitary pads at school and improving school water supply, toilet and hand washing facilities to help girls have the menstrual products, safe and private places to change or clean and dry the pads. The first stage will also include looking for ways to relief girls from pain during menstruation.
The second stage will involve researchers working with local government leaders and school teachers, to look at ways of including the improved health education programme in the routine school activities. The third stage will involve the assessment of the improved health education programme to see if it can be delivered in a long-term at lower cost, and is accepted by students, teachers and local government leaders. The programme will also be evaluated to see if it helps to change what girls do during their menstruation period and how they think about it.
Although the focus of this study is on problems related to menstruation among girls, it is expected that the boys will get a chance to understand issues related to menstruation as well as benefit from improved water supply, toilet and handwashing facilities at school. Apart from boys, the results are expected to benefit teachers, school officials and the general community. The study will also contribute in improved school participation and performance among school girls.
“During menstruation, girls are usually worried about the blood leaking into clothes while in class. A girl who stains her clothes in class is laughed at. Some girls experience severe pain and may need pain killers. Due to these problems girls may not be comfortable to attend a school with poor facilities or services to support them during this period” Dr Okello says. “Many times they miss attending school for several days each month and their performance may go down“
Dr Okello feels this study came at the right time. “In July 2017 I joined MITU to work in a research that was trying to assess if washing hands with soap every time school children used the toilet will help to reduce worm infection” she says. “The project gave me a chance to work within the schools. It is during this time that I realised that we needed to do more to help adolescent girls gain knowledge, skills and basic resources to manage their menstruation”
Continuing routine immunisations during the pandemic estimated to save more than 700,000 child lives from vaccine-preventable diseases
The health benefits of maintaining routine childhood vaccination programmes in Africa during the COVID-19 pandemic far outweigh the risk of SARS-CoV-2 transmission that might be associated with clinic visits, according to a modelling study published in The Lancet Global Health.
For every additional COVID-19 death that might be associated with additional exposure to the virus during routine clinic visits, the model predicts that 84 deaths in children before five years of age could be prevented by continuing with routine vaccinations. The additional risk of COVID-19 transmission associated with clinic visits is predicted to primarily affect older adults living in the same household as the vaccinated children.
The findings suggest that continuing with usual vaccination schedules could prevent 702,000 child deaths from the point of immunisation until they reach five years of age.
The study looked at all 54 countries of Africa and found that in all countries, the number of child deaths averted through vaccination far exceeded the number of excess COVID-19 deaths that might be associated with clinic visits.
However, the authors acknowledge there are other issues that will affect whether vaccination programmes can continue, such as vaccine supply chain problems or healthcare staff shortages during the pandemic.
Dr Kaja Abbas, joint lead author of the study, from the London School of Hygiene and Tropical Medicine, UK, said: “We found that, even with our most conservative estimates, the benefits of routine childhood immunisation in Africa are likely to far outweigh the risk of additional COVID-19 transmission that might ensue, and these programmes should be prioritised as far as logistically possible.”
National immunisation programmes are at risk of disruption due to the severe health system constraints associated with the ongoing COVID-19 pandemic and physical distancing measures introduced to mitigate transmission of the virus.
Researchers created a mathematical model to assess the risks and benefits of continuing with vaccination programmes during the current pandemic for all 54 countries of Africa. Their model assumes that the spread of COVID-19 in African countries will be similar to other countries that were affected earlier in the pandemic and were unable to control the virus. It estimates around 60% of the population will become infected and that the potential disruption to health services will last for six months.
Exact data on the risk of SARS-CoV-2 infection associated with routine clinic trips for childhood immunisations were not available, so the model was based on assumptions relating to the likely number of people encountered during such a journey, both at the clinic itself as well as during travel there and back again. Risks to the child, accompanying adult and any household members were taken into account. The model also accounted for the household size and age composition in each country, as risk of death from COVID-19 is known to substantially increase with age.
The researchers based their estimates of the number of childhood deaths that could be prevented by routine immunisations on existing health data from each country. They focused on the impact of vaccines for diptheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and Streptococcus pneumoniae (bacterial causes of pneumonia and meningitis), rotavirus, measles, rubella, meningitis A and yellow fever. Vaccination rates for each country were assumed to be the same as in 2018.
According to the model, continuing with routine immunisation programmes may lead to 8,300 additional deaths across Africa (uncertainty interval 1,300 to 25,000), attributable to SARS-CoV-2 infections associated with children visiting immunisation clinics.
However, suspending such vaccination programmes to avoid excess COVID-19 deaths could lead to 702,000 children across Africa dying from preventable diseases before the age of five (uncertainty interval 635,000 and 782,000), according to the model. The researchers say this scenario assumes no catch-up vaccination campaigns at the end of the COVID-19 risk period and may overestimate the negative impact of suspending vaccination services for a short period of time.
Even in a much more conservative scenario (where suspending vaccination is primarily assumed to increase the chance of a local measles outbreak and children would be protected from other diseases from existing immunity in the population or catch-up immunisation campaigns at the end of the COVID-19 risk period), the number of childhood deaths that could be prevented was still greater than the potential increase in COVID-19 deaths for most countries of Africa.
Dr Tewodaj Mengistu, co-author of the study, from Gavi, the Vaccine Alliance, Switzerland, said: “Routine immunisation programmes are facing enormous disruption across the globe due to this pandemic. Lockdowns make it harder for vaccinators and parents to reach vaccination sessions, health workers are being diverted to COVID-19 response, and misinformation and fear are keeping parents away. This important study shows just how big an impact this could have, risking the resurgence of diseases that vaccines have kept largely at bay.”
Findings were similar for all 54 countries of Africa, ranging from between 4 and 124 preventable child deaths in Morocco to between 28 and 598 in Angola, for each excess COVID-19 death. One third of vaccine-preventable deaths would be in Nigeria, Ethiopia, Democratic Republic of Congo and Tanzania, the study found. Around one third of vaccine-preventable deaths would be caused by measles, and another third would be attributable to pertussis, according to the model.
While the study clearly shows the health benefits of vaccination for children, it revealed that the additional risk of COVID-19 infections acquired during visits to the clinic would primarily affect adults from the same household. According to the model, 11% of excess COVID-19 deaths attributable to clinic visits are expected to affect parents or adult carers and 88% are predicted to affect older adults living in the same household as the vaccinated children. The researchers say this highlights the importance of shielding older adults to lower their risk of acquiring COVID-19, while children in their households can benefit from routine vaccinations.
Dr Stefan Flasche, senior author of the study, from the London School of Hygiene & Tropical Medicine, UK, said: “We found that the biggest factors affecting the benefit of maintaining childhood immunisations during the pandemic are the likelihood of transmission of COVID-19 during clinic visits and the number of people encountered at the clinic. This highlights the need for personal protective equipment for clinic staff, the need to implement physical distancing measures and avoid crowded waiting rooms, and the importance of good hygiene practices to reduce virus transmission.”
The authors acknowledge that other factors must be considered when making decisions on sustaining routine childhood immunisation programmes during the COVID-19 pandemic. These include vaccine supply chain problems, reallocation of doctors and nurses to other prioritised health services, staff shortages resulting from ill-health or COVID-19 infection, and decreased demand for vaccination caused by fear of contracting COVID-19.
Dr Emily Dansereau, co-author and program officer at the Bill & Melinda Gates Foundation, USA, said: “Across the African continent, many essential health services – from immunization to antenatal care to HIV and TB services – are experiencing significant challenges in the face of COVID-19. To address these new challenges and build resilient health systems, countries are exploring how to rethink health service delivery and are embracing innovative approaches to reach women, children and families with high quality support and care.”
Kaja Abbas*, Simon R Procter*, Kevin van Zandvoort, Andrew Clark, Sebastian Funk, Tewodaj Mengistu, Dan Hogan, Emily Dansereau, Mark Jit, Stefan Flasche, LSHTM CMMID COVID-19 Working Group. Routine childhood immunisation during the COVID-19 pandemic in Africa: a benefit–risk analysis of health benefits versus excess risk of SARS-CoV-2 infection. Lancet Global Health. DOI:10.1016/ S2214-109X(20)30308-9
The investigational antiviral remdesivir is superior to the standard of care for the treatment of COVID-19, according to a report published today in the New England Journal of Medicine. The preliminary analysis is based on data from the Adaptive COVID-19 Treatment Trial (ACTT), sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The randomized, controlled trial enrolled hospitalized adults with COVID-19 with evidence of lower respiratory tract involvement (generally moderate to severe disease). Investigators found that remdesivir was most beneficial for hospitalized patients with severe disease who required supplemental oxygen. Findings about benefits in other patient subgroups were less conclusive in this preliminary analysis.
The study began on Feb. 21, 2020 and enrolled 1,063 participants in 10 countries in 58 days. Patients provided informed consent to participate in the trial and were randomly assigned to receive local standard care and a 10-day course of the antiviral remdesivir intravenously, developed by Gilead Sciences, Inc., or local standard care and a placebo. The trial was double-blind, meaning neither investigators nor participants knew who was receiving remdesivir or placebo.
The trial closed to enrollment on April 19, 2020. On April 27, 2020 (while participant follow-up was still ongoing), an independent data and safety monitoring board overseeing the trial reviewed data and shared their preliminary analysis with NIAID. NIAID quickly made the primary results of the study public due to the implications for both patients currently in the study and for public health. The report published today in the New England Journal of Medicine describes the preliminary results of the trial.
The report notes that patients who received remdesivir had a shorter time to recovery than those who received placebo. The study defined recovery as being discharged from the hospital or being medically stable enough to be discharged from the hospital. The median time to recovery was 11 days for patients treated with remdesivir compared with 15 days for those who received placebo. The findings are statistically significant and are based on an analysis of 1059 participants (538 who received remdesivir and 521 who received placebo). Clinicians tracked patients’ clinical status daily using an eight-point ordinal scale ranging from fully recovered to death. Investigators also compared clinical status between the study arms on day 15 and found that the odds of improvement in the ordinal scale were higher in the remdesivir arm than in the placebo arm. Trial results also suggested a survival benefit, with a 14-day mortality rate of 7.1% for the group receiving remdesivir versus 11.9% for the placebo group; however, the difference in mortality was not statistically significant.
Ultimately, the findings support remdesivir as the standard therapy for patients hospitalized with COVID-19 and requiring supplemental oxygen therapy, according to the authors. However, they note that the mortality rate of 7.1% at 14 days in the remdesivir arm indicates the need to evaluate antivirals with other therapeutic agents to continue to improve clinical outcomes for patients with COVID-19. On May 8, 2020, NIAID began a clinical trial (known as ACTT 2) evaluating remdesivir in combination with the anti-inflammatory drug baricitinib compared with remdesivir alone.
J Beigel, et al. Remdesivir for the Treatment of COVID-19 – A Preliminary Report. The New England Journal of Medicine. DOI: 10.1056/NEJMoa2007764 (2020).
NIAID Director Anthony S. Fauci, M.D., is available for comment.
NIAID conducts and supports research—at NIH, throughout the United States, and worldwide—to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID website.
Full publication : https://www.nejm.org/doi/full/10.1056/NEJMoa2007764