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What is Unity Clinical Trial for Treatment of COVID-19?

"Unity" clinical trial for the treatment of COVID-19

"Unity" is an international clinical trial initiated by the World Health Organization and its partners to help find effective treatments for the COVID-19 disease.

 

The Unity trial compared four treatment options with standard care to assess their relative effectiveness against COVID-19. The solidarity trial recruited patients in multiple countries to quickly discover whether any drugs can slow the progression of the disease or improve survival. Based on emerging evidence, other drugs can be added.

 

Doctors and medical associations not to recommend or use these unproven COVID-19 drugs 

Until there is sufficient evidence, the WHO warns doctors and medical associations not to recommend or use these unproven drugs to COVID-19 patients or self-administered drugs. 

The WHO is concerned about reports of individuals taking chloroquine on their own and causing serious harm to themselves. The WHO guidance document on the use of compassion can be found here.


Update on treatment branch trials

On July 4, 2020, the WHO accepted the recommendation of the International Steering Committee of the "Unity Test" to stop the two branches of hydroxychloroquine and lopinavir / ritonavir in the trial.

 

Infographics on Unity Clinical Trial for Treatment of COVID-19
Utility Clinical Trial

What are the results on comparison of hydroxychloroquine and standard treatment and lopinavir/ritonavir?

According to the results of the solidarity trial interim trial results on the comparison of hydroxychloroquine and standard treatment and lopinavir/ritonavir and standard treatment. Also, after review, WHO COVID-19 research and innovation from July 1 to 2 all the experimental evidence presented at the summit, the International Steering Committee made this recommendation.


The results of the interim trial showed that the use of hydroxychloroquine and lopinavir/ritonavir did not or almost did not reduce the mortality of COVID-19 hospitalized patients compared with standard treatment. The unity test investigator will immediately interrupt the test.

 

According to the results of interim trials, there is no conclusive evidence that the two drugs will increase mortality. 


Discovery trials

However, the clinical laboratory results of the additional items "discovery trials" of the participants in the Unity trial showed some relevant safety signals. 

These will also be reported in peer-reviewed publications.

 

COVID Solidarity Trial

This decision is only applicable to solidarity trials for hospitalized patients, and does not affect the possible evaluation of other hydroxychloroquine or lopinavir/ritonavir efficacy studies conducted for non-inpatients, or as a pre-exposure or exposure to COVID-19 Evaluation of post-preventive therapy. 

The solidarity trial mid-term results are now ready and will be published after peer review.

 

 

What is the reason for COVID19 Unity Trial?

COVID-19 puts pressure on the health system, so WHO considers that trials need to reach a certain speed and scale.

Generally, the design and implementation of randomized clinical trials will take several years, but solidarity trials will reduce the time required by 80%.


Enrolling patients in a single randomized trial will help facilitate the rapid comparison of unproven treatments on a global scale. 

This will overcome the risk that multiple small-scale trials will not produce the strong evidence needed to determine the relative effectiveness of potential drugs.

 

How to take part in the solidarity experiment?

As of July 1, 2020, 21 of the 39 countries that have approved the start of recruitment have recruited nearly 5,500 patients.

 More than 100 countries in all 6 regions of WHO have participated or expressed their wish to participate in the trial. WHO is actively supporting these countries:

  • Approval of the WHO core procedures from both ethical and regulatory aspects
  • Determine the hospitals participating in the trial
  • Train hospital clinicians to master the network-based random allocation and data system
  • Delivery of test drugs according to the requirements of participating countries


Donations from pharmaceutical factories promoting the provision of thousands of courses of medication

The more participating countries, the faster the results will be produced. 

Through donations from several pharmaceutical factories, WHO is promoting the provision of thousands of courses of medication for participating institutions.

 The WHO also invites developers and companies to cooperate to ensure that drugs that ultimately prove effective are available and affordable.


Does Unity Therapeutics trial provide conclusive evidence for the effectiveness of COVID-19 repurposed drugs in record time?

In just six months, the world's largest randomized controlled trial of COVID-19 therapy provided conclusive evidence on the effectiveness of several repurposed drugs used to treat COVID-19.

 

The interim results of the solidarity treatment trial coordinated by the World Health Organization indicate that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon therapy appear to have an effect on the 28-day mortality rate of hospitalized patients or the duration of COVID-19 hospitalization with little or no impact.

 

The study covered more than 30 countries and studied the effects of these treatments on the overall mortality, initiation of ventilation and length of stay in hospitalized patients. 

Other uses of drugs, such as treating patients in the community or for prevention, will need to be examined using different tests.

 

What does progress made in Solidarity trial show?

The progress made in the Solidarity treatment trial shows that even during a pandemic, large-scale international trials are possible. 

Such trials offer the prospect of rapid and reliable answers to key public health questions related to therapies.

 

The results of this trial are under review, will be published in a medical journal, and have been uploaded to medRxiv as a preprint, available through the following link: https://www.medrxiv.org/content/10.1101/2020.10.15.20209817v1.

 

The global platform of the unity trial is ready to quickly evaluate promising new treatment options, and nearly 500 hospitals can be opened as trial sites.

 

The evaluation of new antiviral drugs, immunomodulators, and monoclonal antibodies against SARS COV-2 is being considered.



 


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