We are in for the long-haul with COVID-19, as the rotating apex of the pandemic now jumps across the Atlantic to North America.
Regardless of how this disease continues to play out this northern hemisphere summer, we in Nepal and elsewhere will still be dealing with it for the rest of 2020. All models predict there will be ‘hill and valley’ outbreaks as the epidemic peaks and falls.
Widespread testing, hand washing, physical distancing and masks in certain situations will certainly make a difference together with lockdowns of the kind we are going through.
An effective vaccine will be the game-changer, but it is still at least a year away if we are lucky. In the meantime a potent drug therapy antidote against this disease would be most welcome.
Labs in China, Italy, France, USA, the UK and other countries are doing drug trials even as they deal with the onslaught of the disease. Once the disease is established, there is no other way but to do proper drug trials to treat the disease.
The World Health Organization (WHO) has come up with an innovative idea of carrying out what it calls a public health emergency ‘Solidarity’ trial – an international, randomised trial of hospitalised patients with COVID-19.
This is ground-breaking because rich and poor countries will be involved in the study, and crucially, it is being carried out in the midst of the pandemic. There was a time when studies like these would be considered after the dust settled.
Difficult as it may be, the pandemic is the best time to find a treatment so that more people can benefit. Large sample sizes are needed for conclusions from such a study to be robust and reliable. Findings from a trial using 100 patients will be less certain than a study which employs 1,000.
Norway, South Africa, Argentina, and Iran among others have already signed up for the study which has just begun. The WHO is inviting many countries to participate in Solidarity trials so that the results can be generalised and trustworthy.
Because the study is being carried out ‘in the heat of the battle’ WHO has kept the study very simple. The trial procedures are greatly simplified, and no paperwork is required. Once the institution has obtained national approval and informed consent from the patient, electronic data entry takes a few minutes.
These modern studies using electronic data entry versus paperwork are really not new in countries in South Asia including Nepal which have taken part in state-of–the art collaborative studies before.
This WHO COVID-19 trial has four drug arms: Remdesivir, Kaletra (2 anti-HIV drugs), Interferon and Kaletra, and Chloroquin or hydroxychloroquin. All patients will receive the standard of care in their country, and in addition will be randomised to one of the arms.
These drugs are not new and have been used against various viral and parasitical diseases in the past. For example, chloroquin has been used for many decades against malaria. Doctors will be familiar with these repurposed drugs and their side-effects which sometimes can be worse than the treatment. Hence the importance of a robust drug trial.
The final outcomes to determine which is the best choice, if any, among these four arms have also been kept clear-cut: number of deaths, ventilator use, and number of days in hospital.
Because this is a WHO-lead practical study focusing on helping resource-limited settings, it is important that countries in South Asia including Nepal be involved. Funding may not necessarily be a problem. Many countries in South Asia can at least be randomised to chlorquin or hydroxycholorquin which are not expensive to see if this drug works against COVID-19 or not.
President Trump said he “felt good” about hydoxychloroquin, but this needs scientific backing which does not exist yet. The published French study that concluded usefulness of chloroquin had a very small sample size, did not report clinical outcomes and was not randomised to be scientifically sound.
Similarly the Chinese study using Kaletra and recently reported in the New England Journal of Medicine also had shortcomings. Hence the need for a larger sample size which the WHO’s Solidarity trial is poised to do.
In Nepal, the best-placed institution to help carry out such an important study with potentially multiple hospitals involved is the Nepal Health Research Council ( NHRC), a revered 30-year-old institution.
True, Nepal has only three COVID-19 patients in hospitals right now, but the possibility of this number growing exponentially soon cannot easily be dismissed. It is best to get the practical research system in place, especially because the WHO will welcome the move, and may help with the process so that we may be better able to help our patients with useful, and not harmful, drugs.
It will also give NHRC a chance to help nurture the talent of a young Nepali researcher to help drive this study in Nepal, coordinating with the different hospitals. This is an opportunity that should not be missed.
Buddha Basnyat is a clinical researcher at Patan Academy of Health Sciences and a frequent health columnist for Nepali Times.