More than 200 new crown trials are about to be completed this summer, data analysis is particularly busy
Last Update: 2020-06-16
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With less than three months to go before the World Health Organization (WHO) announced its entry into the global pandemic, and five months after the first sequencing of the new coronavirus, drug development has progressed to the point where hundreds of clinical trials are about to read dataWith a bunch of re-positioned drugs (new drugs), a new vaccine, and the first batch of new coronavirus neutralizing antibodies, screening of mechanisms and patterns may soon beginClinical trials grow rapidly as outbreaks develop, and observations of compounds and therapeutic mechanisms in these studies suggest biological questions that may be answered in the near future, while an assessment of the size, comparative indicators, and stages of the trial can help separate upcoming signals from noiseBetween June 1 and August 31, at least 232 clinical trials of new drugs and vaccines for neo-coronary pneumonia will be completed or produce medium-term results, meaning that by the end of this fall, drug developers and health professionals should have a clearer picture of when and what strategies to respond toThe clinical trial information comes from the National Library of Medicine's Clinical Trials Database (clinicaltrials.gov) and the China Clinical Trials Registry website (Chart 1Number of clinical trials completed or produced in the medium term in 2020 Source: clinicaltrials.gov, chictr.org.cn, China Health Industry Capital Research Center, several new crown vaccine trials this summer, new vaccines and drugs for the new coronavirus have rushed into clinical trials and are beginning to match the re-positioning drugsTwo leading vaccine companies, Moderna (NASDAQ: MRNA) and Consino Bio (HKEX:6185), have published preliminary results of their respective vaccines ininducing viruses and antibodies in healthy volunteersPreliminary data on up to eight vaccines were available at the end of the summer, including Ad5-nCoV in Consino, mRNA-1273 in Moderna, INO-4800 in Inovio, PiCoVacc of Coshing Bio, National Medicines The Group's two new crown virus inactivated vaccines, AstraZeneca/Oxford University/Vaccitech's AZD1222 (ChAdOx1nCoV-19), Novavax/Emergent Biosolutions' NVX-CoV2373The fastest-paced anti-spike-co-vVV555 from Eli Lilly and Abcellera Biologics Inc will begin clinical testing this week (June 8-14), with the first data expected to be released by the end of JuneViral neutral monotoreactors are cause for concern because of their potential in preventive and treatment settingsAt least three other viral neutral monovirus research and development projects are scheduled to launch clinical trials this summer, including Lilly's JS016 with Junshi Bio (HKEX:1877), a partnership between VirBiotechnology Inc (NASDAQ:VIR) and GSK (VIR-7831, VIR-7832), and Regeneron's REGN-COVV2JS016 reduces the risk of antibody-mediated damage through Fc modificationVIR-7831 extends half-life through Fc modification and can be intersected with SARS coronavirusVIR-7832 extends half-life through Fc modification and enhances binding to immunoactivated receptors, which can also be neutralized with SARS coronavirusREGN-COV2 is an "antibody cocktail" therapy that contains two specific antibodies against the new coronavirusChart 2New coronavirus has been or is about to enter the clinical phase of neutralization of monotonication source: public information, Zhongkang Industrial Capital Research Center re-positioning drug clinical trials many recently concluded clinical trials are the test of re-location drugs (old drugs new)Hydroxychloroquine/chloroquine is by far the most prominent re-positioned drug, with at least 61 clinical trials testing the drug as part of a single-drug or combination therapyUnfortunately, however, a mid-term analysis of the RECOVERY study at Oxford University on 4 June found that hydroxychloroquine failed to work in patients with new coronary pneumonia in hospitalRECOVERY was a large randomized controlled study in which the 28-day mortality rate was 25.7 per cent among 1,542 patients treated with hydroxychloroquine, compared with 28 days for 3,132 patients receiving standard care (p-0.1)For other clinical benefits during hospitalization, the researchers were unable to find evidence of the efficacy of hydroxychloroquineThere is growing evidence that hydroxychloroquine/chloroquine is not effective against neo-coronal pneumonia and is likely to accumulate enough data by the end of the summer to abolish the Emergency Use Authorization (EUA) for hydroxychloroquine/chloroquine, as France has already doneChart 3No fewer than five new crown therapies in clinical trials Source: clinicaltrials.gov, chictr.org.cn, China Health Industry Capital Research Center, other drugs that have proven to benefit little, the number of top10 trials, include the antiviral combination lopinavir/litonevir, which failed to accelerate clinical improvement in a study of 199 patients in China; Of the new crown therapy trials of top10, the only non-relocation therapy (the new drug is the old drug) is interstitial stem cell (MSC), which is undergoing 12 studies and is expected to end this summerInterstitial liver cells are mainly used to prevent or correct excessive inflammation that is thought to cause acute respiratory distress syndrome (ARDS) in patients with severe patients with new coronary pneumonia, mainly because of their anti-inflammatory propertiesThe distribution of clinical trials in different types of drugs Most immunosuppressants have changed their use, leading the way in the classification of new coronadrugs, defeating antiparasitic drugs such as hydroxychloroquine and ivermexin, as well as antiviral drugsThe main method of controlling inflammation through drugs such as tocilizumab is the main method of controlling inflammation, and tozhuzumab is undergoing 11 trials, with the main results due this summerChart 4New crown pneumonia clinical trials by drug type Distribution Source: clinicaltrials.gov, chictr.org.cn, Zhongkang Industrial Capital Research Center in late April, Regeneron's sarilumab (commodity name Kevzara) in patients with severe pneumonia in the new crown pneumonia clinical results showed no significant benefits, an independent data monitoring committee (IDMC) only recommended that "severe" patients continue to participate in the ongoing Phase III studyIn contrast, Roche's Genentech's tocilizumab, Actemra, in the Phase II trial of CORIMUNO-TOCI, had a significant reduction in the need for ventilation or death at the 14-day compound primary endpoint compared to a placeboTrial phase and recruitment distribution Although phase I and I/II clinical trials with fewer patients in the group accounted for less than 15% of the clinical trials to read the results, the scale of clinical trials at all stages was small, with about 46% of the number of patients in clinical trials being less than 100 (Figure 5)Chart 5 The distribution of recruitment stakes for 232 trials read out this summer Source: clinicaltrials.gov, chictr.org.cn, And the Center for Industrial Capital Research in China, only 42% of all 232 trials were placebo-controlled, and about 50% of all 232 trials were not blinded, meaning that the results would be difficult to interpret Chart 6 Clinical trial design program control, blind distribution Source: clinicaltrials.gov, chictr.org.cn, the importance of the main protocol test of the China Kang Industrial Capital Research Center highlights the high proportion of small, non-blind trials, highlighting the need for master protocol for experimental coordination and harmonization The master protocol trial allows the use of the same endpoint, data analysis methods, and other protocol parameters, and the parallel evaluation of multiple treatments These test arms share resources, such as a control arm, and the adaptive design of the structure uses Bayesian statistical methods to understand early which treatments are working At present, at least 9 main protocols have been designed for the new coronal pneumonia drug, and one master protocol has been designed for the vaccine The UK has been a leader in guiding patients, therapies and test sites into the master protocol and preparing for the success of the trial, and has introduced a REMAP-CAP master protocol to test combination therapies (Figure 7) Chart 7 Britain's new main agreement on crown pneumonia Source: Public Information, China Health Industrial Capital Research Centre
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