It is only appropriate that any pandemic the size of COVID-19 is matched by almost equivalent human effort to counter it. A range of treatments have been proposed, but only extensive population based-trials will provide evidence on their safety and efficacy. The need to fast-track development of drugs and a vaccine, and subsequently, the necessity to scale up manufacturing processes have naturally spurred vast, global efforts involving a large number of people, and in one instance, many nations.
The World Health Organisation’s (WHO) Solidarity Trial and the U.K.’s RECOVERY Trial are two of the world’s leading scientific efforts pivoting cutting edge research in the battle against COVID-19. These past weeks have brought these two trials into the limelight, the latest being the study by the RECOVERY Trial that showed success in reducing mortality with low doses of a steroid — dexamethasone — to target lung inflammation.
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WHO Director General Tedros Adhanom Ghebreyesus explained the rationale of the Solidarity Trial: “The pressure COVID-19 puts on health systems means that WHO considered the need for speed and scale in the trial. While randomised clinical trials normally take years to design and conduct, the Solidarity Trial will reduce the time taken by 80%.”
It started out to compare four treatment options against standard of care, to assess their relative effectiveness against COVID-19: Hydroxycloroquine (HCQ), Remdesivir; Lopinavir with Ritonavir; and Lopinavir with Ritonavir plus Interferon beta-1a. On June 17, however, the WHO announced that the HCQ arm of the Solidarity Trial was being stopped. The decision was based on evidence from the Solidarity Trial, the RECOVERY Trial and a Cochrane review of other evidence on HCQ. Data showed that HCQ dId not result in the reduction of mortality of hospitalised COVID-19 patients.
While it came with its own controversy over the validity of data sets used in papers published in two peer-reviewed journals, as the clouds cleared, ultimately the generation of conclusive evidence to suspend HCQ is proof of concept. In the process of moving towards the end point of COVID-19, it is also important to move on to treatments that will work, leaving by the wayside those that are just diversions.
Timeline for a vaccine
The WHO also anchors the Solidarity Vaccine Trial, to evaluate the safety and efficacy of several preventive candidates under development. In a recent webinar organised by Project Echo, Soumya Swaminathan, Chief Scientist, WHO, said the expected timeline for a possible vaccine is between 12-18 months. Further, it is important “ultimately to ensure that the vaccine is available to a large number of people.”
Solidarity II promotes the implementation of serological surveys of SARS-CoV-2. “Understanding the occurrence of SARS-CoV-2 infection is critical for the world to know how frequently infection occurs among different populations, how many people have had mild or asymptomatic infection, how many have been infected but may not have been identified by routine disease surveillance, and what proportion of the population may be immune from infection by SARS-CoV-2 in the future,” the WHO explained.
The RECOVERY Trial was reportedly set up in record time, taking just nine days from conception to launch, and has recruited over 10,000 patients in 176 U.K. hospitals in just two months. Deputy Chief Investigator of the trial, Martin Landray, said: “What we have achieved with RECOVERY is unprecedented, but it couldn’t have been done without the support and commitment of everyone involved .”
It tests existing drugs on hospital in-patients with suspected or confirmed COVID-19. Each participant is randomised to receive either standard hospital care, or one of four active treatments. Besides its recent success with Dexamethasone, it also uses Lopinavir-Ritonavir, Azithromycin, Tocilizumab, and convalescent plasma. The HCQ arm was dropped. Ed Juszczak, associate professor - director, NPEU Clinical Trials Unit, Oxford university notes the path-breaking nature of such trials. “For this trial, the timeline has been re-written. The timescales have gone from months and years to hours and days, which is just phenomenal, and shows what’s possible.”
