They have selected drugs for which many studies are already available and most of the studies have shown discouraging results. They have mentioned that they are selecting these drugs based on evidence from laboratory, animal and clinical studies.
Following treatment option will be considered
Remdesivir; Lopinavir/Ritonavir; Lopinavir/Ritonavir with Interferon beta-1a; and Chloroquine or Hydroxychloroquine.
Do you think that this can provide any additional benefit or game changing therapies for COVID -19?
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-research-on-novel-coronavirus-2019-ncov/solidarity-clinical-trial-for-covid-19-treatments
Yes these trial might provide potential treatment options for these clinical trials, alleviating the financial and procurement responsibility of already overburdened hospitals. The pressure COVID-19 puts on health systems means that WHO considered the need for speed and scale in the trial. While randomized clinical trials normally take years to design and conduct, the Solidarity Trial will reduce the time taken by 80%.
WHO is not only leading the global search for a treatment through the Solidarity Clinical Trial, but also ensuring that when a treatment is found, all COVID-19 patients around the world will have access to it. The world needs the development, production and equitable delivery of safe and effective COVID-19 vaccine, therapeutics and diagnostics. Not a vaccine or treatments for one country or one region or one-half of the world — but a vaccine and treatments that are affordable, safe, effective, easily-administered and universally available — for everyone, everywhere.”
WHO-supervised SOLIDARITY trial (1) is a randomised controlled international trial that would test the following medications in COVID-19 patients:
- Remdesivir
- Lopinavir/ritonavir combined
- Lopinavir/ritonavir combined with interferon-beta
- Hydroxychloroquine or chloroquine
However, to date some early results have already shown that Hydroxychloroquine or chloroquine alone or in combination with azithromycin does not decrease the COVID-19 mortality (1-2). Similar results are found for Lopinavir/ritonavir combined (3).
Only Remdesivir has shown early potential benefits.
Being a larger and international study, SOLIDARITY Trial would give the final answer whether any of the medications used in this trial makes any difference on mortality of COVID-19 patients and the results will be eagerly awaited by the global medical community.
1. https://www.trialsitenews.com/who-launches-global-megatrial-of-the-four-most-promising-coronavirus-treatments/
2. Article Observational Study of Hydroxychloroquine in Hospitalized Pa...
3. Article Association of Treatment With Hydroxychloroquine or Azithrom...
4. Article A Trial of Lopinavir–Ritonavir in Adults Hospitalized with S...
The overall idea and brute force design of the Solidarity Trial by the WHO is smart.
And I like and support it.
Many countries and hospitals can contribute very fast to data collections of which new approaches work or work not.
The idea was if one approach does not work, it shall be replaced by other ideas...
Two out of four arms have been stopped:
"Latest update on on treatment arms
Posted 6 July 2020
On 4 July 2020, WHO accepted the recommendation from the Solidarity Trial’s International Steering Committee to discontinue the trial’s hydroxychloroquine and lopinavir/ritonavir arms.
The International Steering Committee formulated the recommendation in light of the evidence for hydroxychloroquine vs standard-of-care and for lopinavir/ritonavir vs standard-of-care from the Solidarity trial interim results, and from a review of the evidence from all trials presented at the 1-2 July WHO Summit on COVID-19 research and innovation.
These interim trial results show that hydroxychloroquine and lopinavir/ritonavir produce little or no reduction in the mortality of hospitalized COVID-19 patients when compared to standard of care. Solidarity trial investigators will interrupt the trials with immediate effect.
For each of the drugs, the interim results do not provide solid evidence of increased mortality. There were, however, some associated safety signals in the clinical laboratory findings of the add-on Discovery trial, a participant in the Solidarity trial. These will also be reported in the peer-reviewed publication.
This decision applies only to the conduct of the Solidarity trial in hospitalized patients and does not affect the possible evaluation in other studies of hydroxychloroquine or lopinavir/ritonavir in non-hospitalized patients or as pre- or post-exposure prophylaxis for COVID-19.
The interim Solidarity results are now being readied for peer-reviewed publication."
OK and here my question:
Why have not two new legs choosen?
The successes received yet have not been resulted in the WHO solidarity study:
- dexamethasone,
- Corticosteroid mix (dexamethasone and hydrocortisone and...) and
- Ivermectin...
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