The London School of Hygiene Tropical Medicine (LSHTM) founded in 1899, specializes in public health and tropical medicine and now pursues a significant adaptive clinical trial affording the study team the ability to change the investigational products should evidence on the benefits or harm of the intervention being trialed implicate a particular direction. In the case of this Phase 3 trial, the prominent investigational team, operating in the West African country of The Gambia investigates the impact of cheap and widely available investigational products starting with Ivermectin. Targeting 1,200 participants, the investigators from the LSHTM’s Medical Research Council (MRC) unit assess the impact of Ivermectin, an anti-parasite drug approved by the U.S. Food and Drug Administration and many regulatory bodies around the world, on the natural history of SARS-CoV-2 in two cohorts, including 1) those with mild or moderate pneumonia (Cohort 1) and 2) those with severe pneumonia (Cohort 2), via a randomization to non-identical placebo or intervention arm. Led by the MRC Unit The Gambia at LSHTM, one of two research units established in sub-Saharan Africa by the Medical Research Council UK, it is the single largest investment in medical research in a low and middle income country. The movement to investigate Ivermectin as a safe and effective treatment for COVID-19 grows.
A geographically small, very narrow nation in West Africa; The Gambia borders follow the meandering Gambia River. Less than 31 miles wide at the country’s widest point, its total square mileage is about 500 square miles making it the smallest country on the African mainland and for comparison it would cover a bit less than Jamaica. The country is surrounded by Senegal by three sides and the Atlantic Ocean to the west.
Long subject to feuding colonial powers such as the British and the French, the nation gained its independence from the United Kingdom in 1965. For three decades thereafter, the country was run democratically via a liberal democracy until a military coup in 1994 changed the course of the nation toward military rule. However, a new constitution was authored and by 1996, the country moved again toward a more democratic style of government—albeit still authoritarian. However, by the 2016 election, the country changed course again led by opposition parties seeking a more full representation. Just recently the constitution was amended yet again but a move to institute Sharia law fell short.
With a liberalized market-based economy, the nation primary depends on subsistence (agriculture accounts for about 30% of GDP). English is the official language and the 2.5 million population is overwhelmingly Islamic. However, tourism has steadily grown as the nation represents a treasure trove of golden beaches, forests, sleeping fishing villages and lagoons with nature preserves as well as wildlife sanctuaries. The recent pandemic has significantly impacted the tourist economy. The nation was a major hub during the slave trade and many Blacks in the Americas potentially can trace a connection to the country. In fact, Alex Haley’s epic story Roots started there. And some thousands of Blacks from both the U.S. and the UK have sought to relocate there. Leaving cities such as San Francisco, Chicago and New York, a small but notable number now call the nation home.
This trial is being conducted in The Gambia by the MRC Unit The Gambia at the LSHTM working closely with the Gambian Ministry of Health. A long list of investigators and government officials have designed the trial and are working on its implementation which is very important for the country and the region. On the other hand, trial implementation is also very challenging due to the stigmatization surrounding COVID-19. Targeting 1,200 participants, the Medical Research Council, London School of Hygiene Tropical Medicine (LSHTM) sponsors one of the larger studies to date that started in January according to a recent disclosure with clinicaltrials.gov.
An adaptive study, the study includes two cohorts including (1) current index cases with mild COVID-19 or moderate pneumonia randomized to Ivermectin 0.3-0.4 mg/kg daily for three days (arms 1 and 2) or non-identical placebo (arm 3). Index case randomization will also include HH members to be treated with Ivermectin 0.3-0.4 mg/kg daily for three days (arm 1) or non-identical placebo (arms 2 and 3). All households will receive a preventative package containing soap and personal protective equipment such as masks; (2) patients admitted to hospital meeting World Health Organization (WHO) criteria for severe COVID-19 pneumonia will be randomized to aspirin 150mg or non-identical placebo for 28 days or until hospital discharge (whichever is sooner) as reported in clinicaltrials.gov. Other care will follow National guidelines.
Carried out in multiple trial sites within The Gambia, with the option to recruit from other Western African countries should it be necessary. Of course the study team would be subject to further local ethical reviews.
This study again commences this month with the planned Estimated Primary Completion Date is March 2022, and the Estimated Study Completion Date of July 2022.
The Research Team
The study is led by a two principal investigators and a study director. Effua Usuf, MBChB, PhD, with MRC, The Gambia at London School of Hygiene & Tropical Medicine. Dr. Usuf, a Clinical Epidemiologist has focused in the past on a major Pneumococcal Surveillance Project headed by Dr. Grant Mackenzie.
Additionally involved from the MRC is Behzad Nadjm, MBChB, FRCP as well as University College London NHS Foundation Trust. Anna Roca, PhD, serves as the Study Directorl educated in Spain, she has been working as an epidemiologist in The Gambia for over a decade.
MRC Unit The Gambia LSHTM
The MRC Unit The Gambia at LSHTM represents a unique concentration of scientific expertise and high quality research platforms in the West African region. Focused on investigator-initiated studies that combine excellent laboratory facilities as well as access to the field, the group works with well-defined populations supportive of their dedication to research. They bring what they are proud to declare GCP complaint trials via rigorous ethical procedures. Their significant portfolio of research spans basic research to the various studies centering on the control of diseases of public health importance in this region of Africa.
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