More than 200 new crown trials are about to be completed. Data analysis is extremely busy this summer

Wu Yanzu, Baiziwan < br / > less than three months after the World Health Organization (who) announced the global pandemic, and five months after the first sequencing of new coronavirus, the drug development has progressed to the extent that hundreds of clinical trials are about to read data, which is really "new coronavirus speed"With a bunch of repositioning drugs (old drugs and new ones), a new vaccine and the first batch of new coronavirus neutralizing antibodies, the screening of mechanism and mode may start soon< br / > the observation of compounds and therapeutic mechanisms in these studies suggests some biological problems that may be solved in the near future, and the evaluation of trial scale, comparative indicators and stages can help to separate the coming signals from noiseNovel coronavirus pneumonia trials and treatment trials will end or produce mid term results in the world from June 1st to August 31stThis means that after the fall of this year, drug developers and health professionals will have a clearer understanding of when and what strategies they will respond to in 232These clinical trials come from the clinical trials database of the National Library of Medicine（ ClinicalTrials.gov ）, and the website of China clinical trial registration center（)。 < br / > < br / > < br / > < br / > < br / > new vaccines and drugs for new coronavirus have entered the clinical trial phase, starting to keep pace with the repositioning drugsTwo leading vaccine companies, Moderna (NASDAQ: mRNA) and kangxinuo Biology (HKEx: 6185), have published the preliminary results of their respective vaccines inducing virus neutralizing antibodies in healthy volunteersAt the end of this summer, preliminary data of up to eight vaccines are available, including Ad5 ncov of conchino, mrna-1273 of Moderna, ino-4800 of inovio, picovacc of Kexing biology, two new coronavirus inactivated vaccines of Sinopharm group, azd1222 of AstraZeneca / Oxford University / vacitech, nvx-cov2373 of Novavax / emergent biosolutions< br / > the neutralizing McAb ly cov555 against spike protein, the fastest growing anti coronavirus, is from Eli Lilly and abcellera biology Incclinical tests will begin this week (June 8-14)The first batch of data is expected to be released by the end of June this year< br / > virus neutralizing mAb has attracted attention due to its potential in the prevention and treatment environmentAt least three more virus neutralizing mAb research and development projects are planned to start clinical trials this summer, including Lilly's joint project with js016, virbiotechnology Inc (NASDAQ: VIR) and GSK (vir-7831, vir-7832), and regeneron's regn-cov2Js016 reduces the risk of antibody mediated damage by FC modificationVir-7831 can prolong half-life by FC modification and cross neutralize with SARS coronavirusVir-7832 can be cross neutralized with SARS CoV by FC modification, which can prolong half-life and enhance binding with immune activated receptor Regn-cov2 is an "antibody cocktail" therapy containing two specific antibodies against the new coronavirus < br / > < br / > < br / > hydroxychloroquine / chloroquine is the most prominent repositioning drug so far At least 61 clinical trials have tested the drug as part of single drug therapy or combination therapy Unfortunately, novel coronavirus pneumonia in June 4th failed to play a role in the hospitalization of new crown pneumonia patients in June 4th Recovery is a large randomized controlled study in which 28 day mortality was 25.7% in 1542 patients treated with hydroxychloroquine, compared with 23.5% in 3132 patients treated with standard care (P = 0.1) For other indicators of clinical benefit during hospitalization, the researchers failed to find evidence of the efficacy of hydroxychloroquine Novel coronavirus pneumonia / chloroquine has been increasingly used to treat new crown pneumonia is likely to accumulate enough data to abolish the emergency use authorization of hydroxychloroquine / chloroquine (EUA) by the end of this summer, as France has done < br / > < br / >, The clinical recovery rate did not improve on the 7th day of treatment < br / > of the top 10 new crown therapies tested, the only non repositioning therapy (old drug and new drug) is mesenchymal stem cell (MSc) therapy, which is under 12 studies and is expected to end this summer Mesenchymal stem cells are novel coronavirus pneumonia, which is used to prevent or correct the excessive inflammation of acute respiratory distress syndrome (ARDS), which is considered to cause severe acute respiratory syndrome (CNS) in severe acute respiratory syndrome patients < br / > most immunosuppressants have changed their use and are in the leading position in the research of new crown drug classification They have defeated the antiparasitic drugs such as hydroxychloroquine and ivermectin, as well as the antiviral drugs Inhibition of IL-6 by drugs such as tocilizumab is the main method to control inflammation There are 11 trials of tocilizumab The main results are completed this summer In late 4, novel coronavirus pneumonia (Regeneron) sarilumab (trade name Kevzara) did not show significant benefit in clinical outcomes of patients with severe acute respiratory syndrome, and an independent data monitoring committee (IDMC) recommended only "severe" patients to continue to participate in the III phase being studied In contrast, tocilizumab (actemra) of Genentech, a gene owned by Roche, showed a significant reduction in the need for ventilation or death at the composite primary end point at 14 days compared with placebo in the phase II corimuno-toci trial < br / > although the phase I and I / II clinical trials with fewer enrolled patients account for less than 15% of the clinical trials to be read out, the scale of clinical trials in all stages is relatively small, with about 46% of clinical trials involving less than 100 patients (Table 5) < br / > < br / > < br / > < br / > in addition, only 42% of the 232 trials are placebo-controlled, and about 50% of the 232 trials are not blinded, which means that the interpretation of the test results will be difficult < br / > < br / > < br / > < br / > The master protocol trial allows for the use of the same endpoints, data analysis methods, and other protocol parameters, and parallel evaluation of multiple treatments These arms share resources, such as a control arm, and the adaptive design of the structure uses Bayesian statistical methods to understand which treatments are working as early as possible At present, novel coronavirus pneumonia is designed by at least 9 Master Agreements, and 1 master protocols have been designed for vaccines The UK has been leading the way in guiding patients, therapies and test sites into the master protocol trials, preparing for the success of the trials, as well as launching a remap-cap master protocol to test combination therapies (Figure 7)