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20 november 2020: De WHO raadt het gebruik van remdesivir af bij patiënten besmet met het coronavirus - Covid-19. Dit afraden gebeurt binnen een half jaar nadat de FDA en EMU remdesivir versneld goedgekeurd hebben. Ook de Nederlandse regering heeft miljoenen doses van remdesivir besteld. Dit is toch wel opmerkelijk te noemen. Terwijl in NEJM op 5 november nog een studierapport werd gepubliceerd met juist bewijs van effectiviteit: Remdesivir for the Treatment of Covid-19 — Final Report 

Officiele standpunt van WHO staat in deze PDF: 

The latest version ofthis WHOliving guidance focuses on remdesivir, following the 15October 2020 preprint publication of results from the WHOSOLIDARITY trial. It contains a weak or conditional recommendation against the use of remdesivir in hospitalised patients with covid-19

16 oktober 2020: WHO - Solidarity Therapeutics Trial

Tussentijdse resultaten van de Solidarity Therapeutics Trial, gecoördineerd door de Wereldgezondheidsorganisatie, geven aan dat behandelingen met remdesivir, hydroxychloroquine, lopinavir / ritonavir en interferon weinig of geen effect lijken te hebben op de 28-daagse mortaliteit of het in het ziekenhuis beloop van COVID-19 onder ziekenhuispatiënten.
In de studie, die meer dan 30 landen omvat, werd gekeken naar de effecten van deze behandelingen op de algehele sterfte, het begin van de beademing en de duur van het ziekenhuisverblijf bij ziekenhuispatiënten. Andere toepassingen van de medicijnen, bijvoorbeeld bij de behandeling van patiënten in de gemeenschap of voor preventie, zouden met verschillende onderzoeken moeten worden onderzocht. 

Lees dit onderzoek: Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results

Hier de gegevens uit het abstract:

Repurposed antiviral drugs for COVID-19; interim WHO SOLIDARITY trial results

WHO Solidarity Trial Consortium, Hongchao Pan, Richard Peto, Quarraisha Abdool Karim, Marissa Alejandria, Ana Maria Henao Restrepo, Cesar Hernandez Garcia, Marie Paule Kieny, Reza Malekzadeh, Srinivas Murthy, Marie-Pierre Preziosi, Srinath Reddy, Mirta Roses, Vasee Sathiyamoorthy, John-Arne Rottingen, Soumya Swaminathan
doi: https://doi.org/10.1101/2020.10.15.20209817
This article is a preprint and has not been certified by peer review [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

Abstract

BACKGROUND WHO expert groups recommended mortality trials in hospitalized COVID-19 of four re-purposed antiviral drugs. METHODS Study drugs were Remdesivir, Hydroxychloroquine, Lopinavir (fixed-dose combination with Ritonavir) and Interferon-β1a (mainly subcutaneous; initially with Lopinavir, later not). COVID-19 inpatients were randomized equally between whichever study drugs were locally available and open control (up to 5 options: 4 active and local standard-of-care). The intent-to-treat primary analyses are of in-hospital mortality in the 4 pairwise comparisons of each study drug vs its controls (concurrently allocated the same management without that drug, despite availability). Kaplan-Meier 28-day risks are unstratified; log-rank death rate ratios (RRs) are stratified for age and ventilation at entry. RESULTS In 405 hospitals in 30 countries 11,266 adults were randomized, with 2750 allocated Remdesivir, 954 Hydroxychloroquine, 1411 Lopinavir, 651 Interferon plus Lopinavir, 1412 only Interferon, and 4088 no study drug. Compliance was 94-96% midway through treatment, with 2-6% crossover. 1253 deaths were reported (at median day 8, IQR 4-14). Kaplan-Meier 28-day mortality was 12% (39% if already ventilated at randomization, 10% otherwise). Death rate ratios (with 95% CIs and numbers dead/randomized, each drug vs its control) were: Remdesivir RR=0.95 (0.81-1.11, p=0.50; 301/2743 active vs 303/2708 control), Hydroxychloroquine RR=1.19 (0.89-1.59, p=0.23; 104/947 vs 84/906), Lopinavir RR=1.00 (0.79-1.25, p=0.97; 148/1399 vs 146/1372) and Interferon RR=1.16 (0.96-1.39, p=0.11; 243/2050 vs 216/2050). No study drug definitely reduced mortality (in unventilated patients or any other subgroup of entry characteristics), initiation of ventilation or hospitalisation duration. CONCLUSIONS These Remdesivir, Hydroxychloroquine, Lopinavir and Interferon regimens appeared to have little or no effect on hospitalized COVID-19, as indicated by overall mortality, initiation of ventilation and duration of hospital stay. The mortality findings contain most of the randomized evidence on Remdesivir and Interferon, and are consistent with meta-analyses of mortality in all major trials. (Funding: WHO. Registration: ISRCTN83971151, NCT04315948)

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

ISRCTN83971151, NCT04315948

Funding Statement

Funding was from WHO. No external funding was received.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Research Ethics Committees in each country and WHO Ethics Review Committee

All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.

Yes

Paper in collection COVID-19 SARS-CoV-2 preprints from medRxiv and bioRxiv

Copyright 
The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.

remdesivir, hydroxychloroquine, lopinavir / ritonavir, interferon, coronavirus, covid-19, medicijnen, wetenschappelijke studies, WHO, Solidarity Therapeutics Trial


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