The #COVID19 #antiviral domain within @remap_cap has been updated and is already recruiting! Twenty-seven patients have already been randomized.
The objective of this domain is to determine the effectiveness of different #antiviral agents for #COVID19 patients.
This @remap_cap domain previously compared hydroxychloroquine, lopinavir-ritonavir, and a combination of these agents against a Standard of Care control.
link.springer.com/article/10.100…
link.springer.com/article/10.100…
Another widely available and low-cost anti-parasitic #medicine, ivermectin, has been promoted as being effective against #SARSCoV2. In-vitro and animal model studies report that ivermectin has anti-viral activity against #SARSCoV2 and anti-inflammatory activity in #COVID19.
Possible mechanisms are inhibition of #SARSCoV2 replication, inhibition of nuclear import of host and viral proteins, and competition in binding with the host-receptor binding region of #SARSCoV2 spike protein.
Several studies are available, but all are subject to potential sources of bias, e.g. small sample size, various doses and schedules used, use of concomitant medications, severity of #COVID19 not well described, and study outcomes measures not clearly defined.
In addition, there have been recent concerns regarding the accuracy of some of the ivermectin studies posted on pre-print servers. These concerns highlight the need for the generation of high-quality data to guide clinicians and regulators.
Despite the pre-clinical uncertainty about the mechanism and potential confounders in the clinical data for effectiveness, the limited clinical data supports the possibility of benefit. Furthermore, #COVID19 clinical trials, to date, reported a low occurrence of adverse effects.
Despite the lack of clear evidence base supporting the efficacy and safety of ivermectin in the critically ill, it is being prescribed ‘off label’ to patients in many regions of the world.
Given the wide use, it is imperative to determine the efficacy and safety of ivermectin in the critically ill. Therefore, ivermectin needs to be tested in a larger (not single-centered) high-quality randomized trial. @remap_cap facilitates rapid evaluation of ivermectin.
In the new #COVID19 #antiviral domain within
@remap_cap #COVID19 patients are randomized to no ivermectin (in combination with antiviral agents that are licensed and in standard care) or ivermectin (also permitting the use of antivirals licensed for #COVID19).
@remap_cap #COVID19 patients are randomized to no ivermectin (in combination with antiviral agents that are licensed and in standard care) or ivermectin (also permitting the use of antivirals licensed for #COVID19).
We are excited to further investigate the potential for benefit of ivermectin for #COVID19 patients. Sites in the US, Ireland, the Netherlands, Germany, Pakistan, Nepal, India, and South Africa are in various stages of preparation to participate in this domain.
If you also want to join @remap_cap or this domain, please contact us at remapcap.org, eu.remapcap@umcutrecht.nl, Instagram or LinkedIn.
@nichol_alistair @rhaniffa @YaseenarabiYa @smythm86 @Lennie333 @DrJohnCMarshall @srinmurthy99 @ZahraBhimani @agordonICU @KathyRowan101 @PaulMouncey @LamontagneFran5 @cjmca @dfmcauley
@statberry @MarcBonten @BrunkhorstFrank @peripatetical @ProfHGoossens @ed_litton @RachaelParke @diptesharyal @kennethbaillie
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