Press releases by RECOVERY (Randomised Evaluation of Covid-19 Therapy) Trial, University of Oxford

This UK national clinical trial, conducted by researchers at the University of Oxford in concert with other relevant institutions, aims to identify treatments that may be beneficial for people hospitalised with suspected or confirmed COVID-19... A range of potential treatments have been suggested for COVID-19 but nobody knows if any of them will turn out to be more effective in helping people recover than the usual standard of hospital care which all patients will receive. The RECOVERY Trial is aimed at evaluating the efficacy of such treatments. It has made a series of press statements from end-March 2020. This link takes you to them.

Read here (RECOVERY Trial website)

Russian university completes clinical trials of Covid-19 vaccine

Russia has become the first country to have completed clinical trials of a Covid-19 vaccine candidate, after Sechenov University said that it had concluded its study. According to Sechenov University Center for Clinical Research on Medications head and chief researcher Elena Smolyarchuk, study data showed the vaccine candidate’s effectiveness, reported Russian news agency TASS. Smolyarchuk was quoted by the news agency as saying: “The research has been completed and it proved that the vaccine is safe. The volunteers will be discharged on 15 July and 20 July.”

Read here (Clinical Trials Arena, July 13, 2020)

Why steroids are a Covid-19 game changer

This video provides clear information on how Covid-19 affects our bodies adversely, e.g. via inflammation and over-reaction of the immune system (cytokine storm); why anti-viral remdesivir and drug hydroxychloroquine have been found to be relatively ineffective; and how a low-cost steroid dexamethasone produced quite dramatic positive results in severely affected patients. Although well-produced, this video is a means by the producers Real Science to advertise services like Nebula and CuriosityStream.

View here (Real Science, July 11, 2020)

Human challenge trials with live coronavirus aren’t the answer to a Covid-19 vaccine

‘With vaccines already a target of widespread misinformation campaigns, the death of a single volunteer would likely cause even greater damage. From a public health perspective, it would be especially disastrous if it both slowed the race to develop a coronavirus vaccine and fueled the anti-vaccination movement. There are other ethical considerations. An important principle in human challenge studies is that subjects must give their informed consent in order to take part. That means they should be provided with all the relevant information about the risk they are considering. But that is impossible for such a new disease.’

Read here (STAT News, June 23, 2020)

To date (July 19, 2020), the 1DaySooner campaign has attracted nearly 33,000 volunteers from 140 countries. Read here

Volunteers sign up to put their lives on the line for a coronavirus vaccine

‘Lehua Gray, a 32-year-old product manager in Austin, wants to risk her life for a coronavirus vaccine. A cloud of potentially deadly microbes would be spritzed up her nose — if she’s allowed to a participate in what’s called a human challenge trial.

‘It’s built on a deceptively simple premise: Researchers inject healthy volunteers with an experimental vaccine and then expose them to a pathogen. If the vaccine prevents volunteers from getting sick, the study can accelerate development of a promising formula.’

Read here (Washington Post, June 15, 2020)

Sinovac says early data show its Covid-19 vaccine generated immune responses

‘Sinovac Biotech announced preliminary study results on Saturday showing its experimental Covid-19 vaccine generated immune responses in patients and was safe — early data that suggest it might protect people against infections with the novel coronavirus. The Beijing-based drug maker’s vaccine, called CoronaVac, induced neutralizing antibodies in “above 90%” of people who were tested 14 days after receiving two injections, two weeks apart. There were no severe side effects reported, the company said in a statement. The preliminary results were from a 600-patient, placebo-controlled Phase 2 study. Sinovac is also conducting a 143-patient, placebo-controlled Phase 1 study.’

Read here (STAT News, June 14, 2020)

The role of vitamin D in reducing risk of COVID-19: A brief survey of the literature

‘The evidence that higher vitamin D status is causally linked to lower risk of COVID-19 incidence, severity, and death continues to increase. This brief report outlines what has been learned through early June 2020 and provides links to some of the key references.

‘It should be noted that acceptance of the role of vitamin D supplementation will probably not be achieved before reports are published that demonstrate randomized controlled trials of vitamin D supplementation significantly reduced COVID-19 incidence or death. Several RCTs and observational studies regarding vitamin D supplementation and COVID-19 incidence and outcomes are either in the planning stage or in progress. The obvious groups to study are those at highest risk: dark-skinned people living at high latitudes, people in nursing homes or health care facilities; prisoners; factory workers such as in meat-packing facilities in the U.S.; health care workers. A major problem is that the powers that be see vitamin D as a threat to income and profit, so use the Disinformation Playbook to suppress positive information on vitamin D...

‘In a review published in early April, it was proposed that vitamin D supplementation could reduce the risk of COVID-19. Two mechanisms were identified: 1, reduced survival and replication of viruses through vitamin D-stimulated release of cathelicidin and defensins, and 2, reduced risk of the cytokine storm by reducing production of pro-inflammatory cytokines...’

Read here (Orthomolecular Medicine News Service, June 9, 2020)

The pandemic's first major research scandal erupts

‘The controversy is an unfortunate distraction, says Miguel Hernán, a Harvard epidemiologist and co-investigator on an ongoing trial of hydroxychloroquine in Spain and Latin America. “If you do something as inflammatory as this without a solid foundation, you are going to make a lot of people waste time trying to understand what is going on.” Chaccour says both NEJM and The Lancet should have scrutinized the provenance of Surgisphere's data more closely before publishing the studies. “Here we are in the middle of a pandemic with hundreds of thousands of deaths, and the two most prestigious medical journals have failed us,” he says.’

Read here (Science Magazine, June 5, 2020)

99% confident that COVID-19 vaccine will work, says Chinese firm

‘Chinese scientists working on a COVID-19 vaccine have told Sky News they are "99%" sure it will be effective. Sinovac, a Beijing-based biotech company, currently has its coronavirus vaccine in stage 2 trials, with more than 1,000 volunteers participating. Sky News is the first British broadcaster to visit its labs.’

Read here (Sky News, May 30, 2020)

WHO temporarily pauses hydroxychloroquine study due to safety concerns

‘The World Health Organization has temporarily halted studying hydroxychloroquine as a potential Covid-19 treatment due to safety concerns, WHO Director-General Tedros Adhanom Ghebreyesus said during a media briefing in Geneva on Monday.

‘The decision was made after an observational study published Friday in the medical journal The Lancet described how seriously ill Covid-19 patients who were treated with hydroxychloroquine and chloroquine were more likely to die. Tedros said that an independent executive group is now reviewing the use of hydroxychloroquine in WHO's Solidarity Trial. The executive group represents 10 of the participating countries in the trial.’

Read here (CNN, May 25, 2020)

Take a shot, isolate at hotel: Chinese volunteer 048 describes Covid-19 vaccine trial

‘We were treated pretty well, says one of 108 participants in trial in Wuhan, whose results were published on Friday. The potential vaccine has since become the world’s first to enter a second phase of human testing, according to WHO.’

Read here (South China Morning Post, May 25, 2020)

Hydroxychloroquine or chloroquine with or without a macrolide for treatment of Covid-19: A multinational registry analysis

‘Hydroxychloroquine or chloroquine, often in combination with a second-generation macrolide, are being widely used for treatment of COVID-19, despite no conclusive evidence of their benefit. Although generally safe when used for approved indications such as autoimmune disease or malaria, the safety and benefit of these treatment regimens are poorly evaluated in COVID-19.

’We were unable to confirm a benefit of hydroxychloroquine or chloroquine, when used alone or with a macrolide, on in-hospital outcomes for COVID-19. Each of these drug regimens was associated with decreased in-hospital survival and an increased frequency of ventricular arrhythmias when used for treatment of COVID-19.’

Read here (The Lancet, May 22, 2020)

First human trial of COVID-19 vaccine finds it is safe and induces rapid immune response

‘These results represent an important milestone. The trial demonstrates that a single dose of the new adenovirus type 5 vectored COVID-19 (Ad5-nCoV) vaccine produces virus-specific antibodies and T cells in 14 days, making it a potential candidate for further investigation,’ says Professor Wei Chen from the Beijing Institute of Biotechnology in Beijing, China, who is responsible for the study. ‘However, these results should be interpreted cautiously. The challenges in the development of a COVD-19 vaccine are unprecedented, and the ability to trigger these immune responses does not necessarily indicate that the vaccine will protect humans from COVID-19. This result shows a promising vision for the development of COVID-19 vaccines, but we are still a long way from this vaccine being available to all.’

Read here (Science Daily, May 22, 2020)

This is the original report in The Lancet. Read here (The Lancet, May 22, 2020)

‘Advance market commitment for Covid-19 vaccine’ by Gavi, the vaccine alliance

‘If the world is to beat COVID-19, we will need to develop one or more vaccines to protect us from it. And with thousands of people dying each week, not to mention an estimated US$ 2 trillion per year in lost economic activity, the pressure to protect the population and return life to normal has never been greater.

‘The positive news is that the global response in terms of vaccine development has been historic. Today, over 80 preclinical candidates are in development and seven have already progressed to human trials. This could well give us a better chance of getting more than one COVID-19 vaccine introduced in record-breaking time. However it also shines a light on another critical challenge: how to ensure that once a vaccine is available, it is accessible to everyone that needs it. We can only stop the pandemic if it is under control everywhere.’

Read here (Gavi, May 4, 2020)

Read more about Gavi here

Finding effective treatments for COVID-19: Scientific integrity and public confidence in a time of crisis

‘Everyone wants new treatments and vaccines to address the devastation of coronavirus disease 2019 (COVID-19). But, currently, under intense pressure and based on hope and limited data from poorly conducted clinical trials and observational data, many clinicians are embarking on ill-advised and uncontrolled human experimentation with unproven treatments.’

This paper calls for three important considerations:

1. ‘First, the regulatory and research communities owe it to patients, families, and clinicians to quickly learn what treatments are effective... 
2. ‘Second, it is important to optimise treatments that already exist, including supportive critical care. As learned from the Ebola outbreak, mortality can be reduced through identifying best practices...
3. ‘Third, and most important, it is critical to protect the integrity of and resulting public trust in the scientific and regulatory agencies and their advice and decisions. That trust will be needed once vaccines against COVID-19 become available and in future public health emergencies.’

Read here (JamaNetwork, April 16, 2020)

Dow futures rally 700 points after Gilead drug reported shows effectiveness. There are reservations about the report and clinical trials funded by Gilead

Dow futures rally. Read here (CNBC, April 16, 2020)

‘Gilead’s severe Covid-19 study includes 2,400 participants from 152 different clinical trial sites all over the world. Its moderate Covid-19 study includes 1,600 patients in 169 different centers, also all over the world.

‘The trial is investigating five- and 10-day treatment courses of remdesivir. The primary goal is a statistical comparison of patient improvement between the two treatment arms. Improvement is measured using a seven-point numerical scale that encompasses death (at worst) and discharge from hospital (best outcome), with various degrees of supplemental oxygen and intubation in between.

‘The lack of a control arm in the study could make interpreting the results more challenging.’

Read here (STAT News, April 16, 2020)

Clinical trials on repurposing two vaccines, BCG and polio: Both statements start with "There is no evidence..."

On polio: ’There is no evidence that oral poliovirus vaccine (OPV) protects people against infection with COVID-19 virus. A clinical trial addressing this question is planned in the USA, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend OPV vaccination for the prevention of COVID-19.’

Download here (Polio Eradication Initiative, March 2020)

On BCG: ‘There is no evidence that the Bacille Calmette-Guérin vaccine (BCG) protects people against infection with COVID-19 virus. Two clinical trials addressing this question are underway, and WHO will evaluate the evidence when it is available. In the absence of evidence, WHO does not recommend BCG vaccination for the prevention of COVID-19. WHO continues to recommend neonatal BCG vaccination in countries or settings with a high incidence of tuberculosis.’

Read here (WHO, April 12, 2020)