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Updates on COVID-19 clinical trials The pace of research and development for treatments and vaccines for the [ ... ]

Updates on COVID-19 clinical trials

The pace of research and development for treatments and vaccines for the novel Coronavirus has intensified, with dozens of clinical trials underway around the world. Several papers were published over the weekend with preliminary findings on the two largest studies that were both stopped for different reasons.

In the New England Journal of Medicine, researchers reported on a randomized double-blind study for remdesivir by the U.S. CDC that was stopped prematurely due to positive preliminary results. For patients hospitalised with COVID-19, the antiretroviral appears to reduce the recovery time (by four days) and mortality (from 12% to 7%), while presenting no additional adverse events. While this is promising, the results appear to be worse for visible minorities (a group that has been disproportionately impacted by the pandemic). Researchers have also been surprised that patients treated sooner after symptom onset may not have markedly better outcomes than those treated later in the course of disease.
A paper in the Lancet, meanwhile, presents on the WHO Global COVID-19 Solidarity Trail on chloroquine and hydroxychloroquine. Based on the advice of the WHO Executive Group – comprised of experts from ten countries involved in the trial – the observational study was stopped as preliminary findings suggest the possibility of higher mortality rates. The WHO Chief Scientist committed to a comprehensive analysis of all emerging clinical trial data globally to consider benefit and harm, acknowledging that unlike randomized controlled trials, observational studies have been known to yield misleading results. Expertshave also critiqued the failure of the study to adequately adjust for the fact that many of the patients in the trial are more likely to be severely ill and already at increased risk of death.

Ethics of controlled Coronavirus infection

An article in Science this week also expresses concern in the growing trend of researchers pursuing, and thousands of people expressing interest in participating in, controlled human infection (CHI) studies, i.e. deliberately exposing healthy people to COVID-19 to study infection and treatment efficacy. The authors present an ethical framework for CHIs that emphasizes “social value” as fundamental in justifying these studies. The proposed Ethical Framework for SARS-CoV-2 CHI considers six additional criteria, including: Reasonable Risk-Benefit Profile, Context-Specific Stakeholder Engagement, Suitable Site Selection, Fair Participant Selection, Robust Informed Consent, and Proportionate Payment.

Everyone in the (patent) pool

More than 100 former heads of government and leading scientists have urged all COVID-19 related research and intellectual property to be shared freely, and for the equitable distribution of vaccines. An editorial this week in Nature laments that the growing concern of “techno-protectionism” necessitates such a letter, while highlighting the remarkable speed of advancements as a result of global consortia of researchers (“Work that would normally have taken months, possibly years, is completed in weeks”). The Nature article focuses particularly on the patent pool model that is was popularized by the UNITAID Medicines Patent Pool that was successful in bringing antiretrovirals to market.

The World Health Assembly Resolution last week made explicit reference to IP rights flexibilities with respect to R&D, manufacturing and distribution of COVID-19 vaccines. Support was not unanimous, however, as some countries (notably the U.S. and the U.K) and research consortia (including the Coalition for Epidemic Preparedness Innovations) expressed their preference for conventional models where vaccine developers retain the IP rights that they may sub-license and their determined price. An article in the Harvard Business Review drew attention to the dangers of this form of ‘vaccine nationalism’, particularly as the underlying research thus far has been pooled and governments around the world have shouldered much of the risk in funding the vaccine effort.

World leaders pledge $8 billion for research into vaccine and therapies as well as equitable and timely distribution (Coronavirus Global Response Summit)

The absence of the U.S., India and Russia points to possible fractures in global health diplomacy (Washington Post)

Vaccine could be available as early as 9-24 months (Gates Foundation)

A vaccine likely won’t be available until the end of 2021 due to Phase 2 and 3 clinical trials to ensure safety and efficacy, according to the chair of the WHO Global Outbreak Alert and Response Network (CNBC)

Nature: Multiple vaccines are in competition: how will scientists choose the best?

Rapid review for the anti-coronavirus effect of remdesivir (Drug Discoveries & Therapeutics)

Video: How does Gilead’s drug remdesivir work against coronavirus? (STAT)

Gilead to charge up to US$4,500 for experimental COVID-19 treatment remdesivir (Institute for Clinical and Economic Research)

WHO to engage U.S. and Gilead as data on safety and efficacy emerge to ensure wider availability of remdesivir (CNBC)

GAVI Vaccine Alliance proposes an Advanced Market Commitment program for COVID-19 vaccine (GAVI)

Internet of Things has been deployed in innovative ways to provide information and monitoring during the COVID-19 epidemic, including automated and transparent treatment (Journal of Diabetes & Metabolic Syndrome)

Emerging technologies to combat COVID-19 pandemic (J of Clinical and Experimental Hepatology)

Going Viral: how to boost the spread of coronavirus science on social media (Nature)

COVID-19 has reinforced the importance of preprints as a means for rapid research dissemination (Nature Biotechnology)

Tool: Google releases an AI-powered COVID-19 Research Explorer to assist researchers with complex queries

UK researchers create antibody test claiming 100% sensitivity, 99.8% specificity and results in 35 minutes (UK Standard)

U.S. Food and Drug Administration tighten standards for antibody testing following false specificity and sensitivity claims (WSJ)

Ethical and practical challenges of COVID-19 human vaccine trials (STAT)

Human Challenge Studies to Accelerate Coronavirus Vaccine Licensure (Journal of Infections Diseases)

WHO to issue ethical guidelines this month to inform human challenge trials amidst reports of deliberate infection of healthy human volunteers to test vaccine candidates (SCMP)

Frontier technologies for COVID-19 need better governance (WEF)

Unproven herbal remedy, ‘Madagascar Tonic’, touted by some African governments despite warnings from health officials (Globe & Mail; The Economist)

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A paper in Nature this week reports that Chinese scientists discovered RNA of the virus in tiny droplets in Wuhan hospitals, raising the possibility of airborne transmission. The range of clinical manifestations in patients that test positive for COVID-19 remains a public health challenge, with some remaining asymptomatic while others die quickly. Despite the more than 1,000 papers that are published every week, a Science articles concludes that a “clear picture is elusive, as the virus acts like no pathogen humanity has ever seen.”

The CDC this week added six new symptoms that may be linked with COVID-19. These include chills, repeated shaking with chills, muscle pain, headache, sore throat and a loss of taste or smell – in addition to previously listed symptoms (fever, cough and shortness of breath or difficulty breathing).

The number of cases in Russia has surged past 100,000 following a record daily increase that included its Prime Minister testing positive. The Prime Minister of Japan has also suggested the country is likely to extend the state of emergency past May 4. Yesterday, Chile announced that it will back away from plans to distribute immunity cards following warnings by the WHO of the lack of evidence of ‘sufficient immunity’ to COVID-19 that would prevent reinfection. In its daily briefing, the WHO also has urged countries to be vigilant and to avoid prematurely lifting control measures as early evidence of sero-epidemiological data suggests a significant proportion of infected people may have been missed by surveillance measures.

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Ten countries have now confirmed more than 1,000 COVID-related deaths, with 14 countries reporting more than 10,000 cases. With less than 17% of all confirmed cases globally, Italy and Spain continue to account for more than 35% of all reported deaths (21,645 and 19,130, respectively). Both countries are experiencing a slow-down in the rates of transmission, however, and while Spain is beginning to relax control measures, Italy has extended lockdown measures until May.

Sweden (12,540) is the latest country to exceed 10,000 cases, as the number of deaths doubled in less than a week, which has been blamed on its controversial voluntary public health measures. France (147,863) and Turkey (69,392) continue to experience significant daily increases in confirmed cases and deaths, while the U.K. is expected to see a drop in new cases and hospitalization, despite surpassing 10,000 deaths and approaching 100,000 cases. The U.K. Prime Minister Boris Johnson was moved out of Intensive Care over the weekend, noting “I owe (NHS staff) my life.”

Transmission rates in Russia have also raised concerns, as daily reported cases continue to surge 20% for a second consecutive day, approaching 28,000 cases and 232 deaths. As the number of COVID-related deaths in Belgium surpass China, Germany is reporting an increase of COVID-related outbreaks in nursing homes and hospitals, where the elderly account for only 17% of cases but 86% of all deaths.

Many European countries are also reporting high CFR near or above 10%, including Italy, Spain, France, the U.K., Netherlands, Belgium, and Sweden. This has been partly attributed to selective testing strategies, as a paper this week in BMJ suggests early and widespread testing may be contributing to Germany’s relatively low CFR (2%). The European CDC has recommended that countries scale up testing and surveillance systems to guide and monitor the escalation and de-escalation of mitigation strategies.

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Updates on COVID-19 clinical trials

In the New England Journal of Medicine, researchers reported on a randomized double-blind study for remdesivir by the U.S. CDC that was stopped prematurely due to positive preliminary results. For patients hospitalised with COVID-19, the antiretroviral appears to reduce the recovery time (by four days) and mortality (from 12% to 7%), while presenting no additional adverse events. While this is promising, the results appear to be worse for visible minorities (a group that has been disproportionately impacted by the pandemic). Researchers have also been surprised that patients treated sooner after symptom onset may not have markedly better outcomes than those treated later in the course of disease.
A paper in the Lancet, meanwhile, presents on the WHO Global COVID-19 Solidarity Trail on chloroquine and hydroxychloroquine. Based on the advice of the WHO Executive Group – comprised of experts from ten countries involved in the trial – the observational study was stopped as preliminary findings suggest the possibility of higher mortality rates. The WHO Chief Scientist committed to a comprehensive analysis of all emerging clinical trial data globally to consider benefit and harm, acknowledging that unlike randomized controlled trials, observational studies have been known to yield misleading results. Expertshave also critiqued the failure of the study to adequately adjust for the fact that many of the patients in the trial are more likely to be severely ill and already at increased risk of death.

Ethics of controlled Coronavirus infection

Everyone in the (patent) pool

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