The WHO has developed the SOLIDARITY trial platform to assess potential therapies for COVID-19. The aim is for thousands of patients to be recruited globally, with standardised data capture that can be easily shared. Currently this protocol has been developed with four treatment arms, but it can be changed at any time and there is scope for adapting this to different settings, and potentially, different endpoints. Many research teams are planning on implementing this study.
The goal of The Global Health Network community is to support COVID-19 research in all settings and clinical contexts to ensure equity in the ability to undertake and engage in research. In turn this ensures that evidence, interventions and recommendations from research are globally applicable and can be put into practice.
It is critical that therapies are tested in different co-morbidities and healthcare contexts. Here we summarise the SOLDARITY protocol and ask: ‘Are you are interested in taking part, and what support would you need?’ We would also like to hear your views on the therapies included so far and comments on how appropriate and feasible these are to your situation.
Our aim is to support WHO’s lead on gaining quality, standardised clinical trial data as rapidly as possible. We aim to help by collating views and pulling together the knowledge and resources that research teams need in order to adapt and implement the SOLIDARITY trial in their centre. The trial is currently designed to assess the following therapies:
- Chloroquine and hydroxychloroquine
Minimal data in man, early trials in China show limited benefit. A high dose may be required, which could cause more adverse-effects, especially in the hydroxychloroquine form. Trials in arboviruses have failed to show benefit. This is an inexpensive drug but consideration would be needed for use in malarious regions (even though this is not used widely as an anti-malaria treatment) because of the risk of antimalarial resistance.
This combination was developed for HIV treatment. It is a protease inhibitor which has shown efficacy in coronavirus animal models.
This is an expensive drug given intravenously, and so may be of limited use in early infection and in the community.
- Ritonavir/Lopinavir plus interferon-beta
Adding interferon-beta to the R/L combination brings inflammatory response regulation. This needs careful safety monitoring for potential adverse-effects.
Key factors for consideration in the target product profile of a therapy to use in early stages would include:
- Safety and tolerability
- Ease of administration
- Scalability of manufacturing
What other questions are there? What trials are there for supportive care therapies? Are there trials investigating late stage disease? What are the most appropriate outcome measures?
Are you considering conducting a trial? Please let us know what you have planned and if you need any support. We want to support the WHO in implementing the SOLIDARITY protocol in different settings and especially in LMICs. Please get in touch and get involved!