Potential Therapeutics

Many thanks to Dr Andy Ustianowski, Principle Clinical Research Lead and Consultant in Infectious Diseases and Tropical Medicine at North Manchester Hospital, for his help with this article. He is also overseeing Gilead's Phase III UK trials of remdesivir for the treatment of Covid-19.

There are, as yet, no proven or licensed treatments for SARS-coronavirus 2. However there are multiple promising agents being investigated.

They tend to fall within 2 main domains – antiviral and immunomodulators, the former targeting the virus directly, the latter attempting to alter the adverse immune mediated inflammation that some individuals develop.

In the UK, there are several trials underway to investigate the use of novel or repurposed therapeutics for the treatment of Covid-19. Some are stand-alone studies, but others are being combined and compared in national platform adaptive studies. The larger platform studies are RECOVERY (in hospitalised patients), REMAP-CAP (in ITU patients) and PRINCIPLE (in the community).

These are presented below using the PICO format. More trials will be rolled out in the coming weeks so check back regularly for more up-to-date information. 

Please liaise with your local research teams to see what is available in your area/hospital.

Randomised Evaluation of Covid-19 Therapy (RECOVERY)

P: Covid-19 positive AND aged >18

I: Randomisation to lopinavir/ritonavir 400/100mg BD PO for 10 days vs. dexamethsone 6mg OD PO/IV for 10 days vs. hydroxychloroquine vs. interferon-beta-1a 6MIU OD neb for 10

C: Standard care

O: Primary: all-cause mortality. Secondary: duration of hospital stay, mechanical ventilation, renal-replacement therapy

Find out how to set up your site for the trial and undertake specific training here.

Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (REMAP-CAP)

P: Community-acquired pneumonia (including Covid and influenza) requiring ICU admission

I: Multiple arms: for Covid interventions include lopinavir/ritonavir 400/100mg BD for 14 days, hydroxychloroquine 200mg BD for 10 days, lopinavir/ritonavir + hydroxychloroquine, interferon-beta1a 10ug IV OD for 6 days, anakinra (anti-IL1Ra) 300mg IV OD

C:  Standard care/no anti-viral agents

O: Primary: all-cause mortality, days alive outside of ICU

Find out more about the trial here.

Platform Randomised trial of INterventions against Covid-19 in older peoPLE (PRINCIPLE)

P: Covid-19 positive AND aged >65 (or >50 with significant listed comorbidities) in the community

I:  Hydroxychloroquine 200mg BD PO for 7 days

C:  Standard care.

O: Primary: Hospital admission or death within 28 days.

The GP practices taking part in this study are listed here.

Phase III Trial: Remdesivir (Moderate and Severe Covid-19)

P: Covid-19 positive AND aged >18,  confirmed lung involvement, 12 days or less since symptom onset. (Moderate: sats >94% on room air, severe: sats 94% or below on room air)

I: 5 days vs 10 days of remdesivir with initial 200mg IV loading dose on day 1 the 100mg OD IV.

C:  Moderate: Standard care. Severe: none.

O: Moderate: Discharge by day 14. Severe: normalisation of fever and oxygen sats by day 14. 

Currently only Manchester Foundation Trust (formerly Pennine Acute) and King’s College Hospital Trust are participating in this trial in the UK.

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